1
40
9
-
Text
A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text.
URL Address
<a href="http://doi.org/10.18553/jmcp.2009.15.s2.5" target="_blank" rel="noreferrer noopener">http://doi.org/10.18553/jmcp.2009.15.s2.5</a>
Pages
S5–11
Issue
2
Volume
15
Dublin Core
The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/.
Title
A name given to the resource
The science of selecting antimicrobials for community-acquired pneumonia (CAP).
Publisher
An entity responsible for making the resource available
Journal of managed care pharmacy : JMCP
Date
A point or period of time associated with an event in the lifecycle of the resource
2009
2009-03
Subject
The topic of the resource
Humans; Microbial Sensitivity Tests; Anti-Bacterial Agents/*therapeutic use; Practice Guidelines as Topic; Streptococcus pneumoniae/isolation & purification; Community-Acquired Infections/drug therapy; *Drug Resistance; beta-Lactams/*therapeutic use; Chlamydophila pneumoniae/isolation & purification; Fluoroquinolones/*therapeutic use; Legionnaires' Disease/drug therapy; Macrolides/*therapeutic use; Pneumonia; Bacterial; Drug Therapy; Bacterial/*drug therapy; Combination
Creator
An entity primarily responsible for making the resource
File Thomas M
Description
An account of the resource
BACKGROUND: Among infectious diseases, community-acquired pneumonia (CAP) is the leading cause of death in the United States and is associated with a substantial economic burden to the health care system. Initiating appropriate empiric therapy can be challenging given elevated resistance rates among Streptococcus pneumoniae strains. OBJECTIVE: To present current recommendations for management of CAP with respect to (a) choosing the appropriate site of care, and (b) antimicrobial selection based on bacterial etiology and the prevalence of resistance. SUMMARY: Mortality prediction tools, such as the PORT (Pneumonia Outcomes Research Team) Severity Index, CURB-65 (Confusion, Urea concentration, Respiratory rate, Blood pressure, and age\textgreater65), or CRB-65 (Confusion, Respiratory rate, Blood pressure, and age\textgreater65), can be invaluable in determining which CAP patients require hospitalization. These tools can help reduce overall costs for CAP by limiting hospitalizations of low-risk patients. S. pneumoniae remains the most common causative pathogen for CAP across all disease severities, and elevated rates of resistance to penicillin and macrolides can hinder selection of appropriate antimicrobial therapy. Antimicrobial resistance can impact clinical outcomes, including increasing the risk of treatment failure and breakthrough bacteremia. Current management guidelines recommend monotherapy with a respiratory fluoroquinolone or combination therapy with a beta-lactam and a macrolide (for patients admitted to the general medical ward) or with a beta-lactam and either a respiratory fluoroquinolone or a macrolide (for patients admitted to the intensive care unit [ICU] and who do not have risk factors for methicillin-resistant S. aureus or Pseudomonas). Optimized dosing regimens aim to ensure that pharmacokinetic and pharmacodynamic targets are met to achieve successful clinical outcomes and minimize resistance development. CONCLUSION: Effective management of patients with CAP requires selection of the proper site of care and appropriate empiric antimicrobial. Given the elevated rates of resistance among S. pneumoniae, local resistance patterns must be considered when choosing empiric therapy.
Identifier
An unambiguous reference to the resource within a given context
<a href="http://doi.org/10.18553/jmcp.2009.15.s2.5" target="_blank" rel="noreferrer noopener">10.18553/jmcp.2009.15.s2.5</a>
Rights
Information about rights held in and over the resource
Article information provided for research and reference use only. All rights are retained by the journal listed under publisher and/or the creator(s).
*Drug Resistance
2009
Anti-Bacterial Agents/*therapeutic use
Bacterial
Bacterial/*drug therapy
beta-Lactams/*therapeutic use
Chlamydophila pneumoniae/isolation & purification
Combination
Community-Acquired Infections/drug therapy
Department of Internal Medicine
Drug Therapy
File Thomas M
Fluoroquinolones/*therapeutic use
Humans
Journal of managed care pharmacy : JMCP
Legionnaires' Disease/drug therapy
Macrolides/*therapeutic use
Microbial Sensitivity Tests
NEOMED College of Medicine
Pneumonia
Practice Guidelines as Topic
Streptococcus pneumoniae/isolation & purification
-
Text
A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text.
URL Address
<a href="http://doi.org/10.1378/chest.125.5.1888" target="_blank" rel="noreferrer noopener">http://doi.org/10.1378/chest.125.5.1888</a>
Pages
1888–1901
Issue
5
Volume
125
Dublin Core
The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/.
Title
A name given to the resource
Guidelines for empiric antimicrobial prescribing in community-acquired pneumonia.
Publisher
An entity responsible for making the resource available
Chest
Date
A point or period of time associated with an event in the lifecycle of the resource
2004
2004-05
Subject
The topic of the resource
Humans; United States; Practice Guidelines as Topic; Canada; Europe; Community-Acquired Infections/drug therapy; Fluoroquinolones/therapeutic use; Lactams/therapeutic use; Macrolides/therapeutic use; Drug Resistance; Pneumonia; Bacterial; Bacterial/*drug therapy
Creator
An entity primarily responsible for making the resource
File Thomas M Jr; Garau Javier; Blasi Francesco; Chidiac Christian; Klugman Keith; Lode Hartmut; Lonks John R; Mandell Lionel; Ramirez Julio; Yu Victor
Description
An account of the resource
Empiric antimicrobial prescribing for community-acquired pneumonia remains a challenge, despite the availability of treatment guidelines. A number of key differences exist between North American and European guidelines, mainly in the outpatient setting. The North American approach is to use initial antimicrobial therapy, which provides coverage for Streptococcus pneumoniae plus atypical pathogens. Europeans tend to focus on providing pneumococcal coverage with less emphasis on covering for an atypical pathogen. Ambulatory patients without comorbidity are more likely to receive macrolide therapy in North America, whereas in Europe these patients would probably receive a beta-lactam agent. Major issues that are fundamental to this difference include the importance of providing therapy for atypical pathogens and the clinical significance of macrolide-resistant S pneumoniae. Prospective data are required to evaluate which of these two approaches offers clinical superiority.
Identifier
An unambiguous reference to the resource within a given context
<a href="http://doi.org/10.1378/chest.125.5.1888" target="_blank" rel="noreferrer noopener">10.1378/chest.125.5.1888</a>
Rights
Information about rights held in and over the resource
Article information provided for research and reference use only. All rights are retained by the journal listed under publisher and/or the creator(s).
2004
Bacterial
Bacterial/*drug therapy
Blasi Francesco
Canada
Chest
Chidiac Christian
Community-Acquired Infections/drug therapy
Department of Internal Medicine
Drug Resistance
Europe
File Thomas M Jr
Fluoroquinolones/therapeutic use
Garau Javier
Humans
Klugman Keith
Lactams/therapeutic use
Lode Hartmut
Lonks John R
Macrolides/therapeutic use
Mandell Lionel
NEOMED College of Medicine
Pneumonia
Practice Guidelines as Topic
Ramirez Julio
United States
Yu Victor
-
Text
A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text.
URL Address
<a href="http://doi.org/10.1378/chest.115.suppl_1.3s" target="_blank" rel="noreferrer noopener">http://doi.org/10.1378/chest.115.suppl_1.3s</a>
Pages
3S–8S
Issue
3
Volume
115
Dublin Core
The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/.
Title
A name given to the resource
Overview of resistance in the 1990s.
Publisher
An entity responsible for making the resource available
Chest
Date
A point or period of time associated with an event in the lifecycle of the resource
1999
1999-03
Subject
The topic of the resource
Humans; Anti-Bacterial Agents/*therapeutic use; Community-Acquired Infections/drug therapy; *Drug Resistance; Cross Infection/drug therapy; Pneumonia; Multiple; Bacterial/*drug therapy
Creator
An entity primarily responsible for making the resource
File T M Jr
Description
An account of the resource
The tremendous therapeutic advantage afforded by antibiotics is being threatened by the emergence of increasingly resistant strains of microbes. Selective pressure favoring resistant strains arises from misuse and overuse of antimicrobials (notably extended-spectrum cephalosporins), increased numbers of immunocompromised hosts, lapses in infection control, increased use of invasive procedures and devices, and the widespread use of antibiotics in agriculture and animal husbandry. Outside the hospital, penicillin-resistant Streptococcus pneumoniae is of greatest concern; recent reports also indicate the appearance of outpatient methicillin-resistant Staphylococcus aureus (MRSA) infections. MRSA is a significant problem in the hospital, as are vancomycin-resistant Enterococcus, oxacillin-resistant S aureus, and multidrug-resistant Gram-negative bacilli. Owing to the high rate of antibiotic use and other risk factors, a person is more likely to acquire an antibiotic-resistant infection in the ICU than anywhere else, either inside or outside the hospital. Responsible antibiotic use and stringent infection-control policies are needed to discourage the development of resistant strains.
Identifier
An unambiguous reference to the resource within a given context
<a href="http://doi.org/10.1378/chest.115.suppl_1.3s" target="_blank" rel="noreferrer noopener">10.1378/chest.115.suppl_1.3s</a>
Rights
Information about rights held in and over the resource
Article information provided for research and reference use only. All rights are retained by the journal listed under publisher and/or the creator(s).
*Drug Resistance
1999
Anti-Bacterial Agents/*therapeutic use
Bacterial/*drug therapy
Chest
Community-Acquired Infections/drug therapy
Cross Infection/drug therapy
Department of Internal Medicine
File T M Jr
Humans
Multiple
NEOMED College of Medicine
Pneumonia
-
Text
A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text.
URL Address
<a href="http://doi.org/10.1185/030079904X2556" target="_blank" rel="noreferrer noopener">http://doi.org/10.1185/030079904X2556</a>
Pages
1473–1481
Issue
9
Volume
20
Dublin Core
The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/.
Title
A name given to the resource
Clinical implications of 750 mg, 5-day levofloxacin for the treatment of community-acquired pneumonia.
Publisher
An entity responsible for making the resource available
Current medical research and opinion
Date
A point or period of time associated with an event in the lifecycle of the resource
2004
2004-09
Subject
The topic of the resource
*Levofloxacin; Administration; Adult; Anti-Bacterial Agents/*administration & dosage/economics; Bacterial/*drug therapy; Community-Acquired Infections/drug therapy; Drug Administration Schedule; Drug Costs; Female; Humans; Infusions; Intravenous; Male; Ofloxacin/*administration & dosage/economics; Oral; Pneumonia; Treatment Outcome
Creator
An entity primarily responsible for making the resource
File Thomas M Jr; Milkovich Gary; Tennenberg Alan M; Xiang Jim X; Khashab Mohammed M; Zadeikis Neringa
Description
An account of the resource
OBJECTIVE: To evaluate the time to symptom resolution and i.v.-to-p.o. transition in community-acquired pneumonia (CAP) patients treated with 750 mg or 500 mg levofloxacin. RESEARCH DESIGN: A retrospective, subset analysis of a multicenter, randomized, double-blind, controlled trial comparing 750 mg levofloxacin for 5 days to 500 mg levofloxacin for 10 days for the treatment of CAP. PATIENTS AND METHODS: A total of 528 CAP patients were included. Baseline symptoms were re-evaluated on Day 3 of therapy, and time to i.v.-to-p.o. transition was recorded for inpatients. RESULTS: For the overall population, 67.4% of patients receiving 750 mg levofloxacin had resolution of fever by Day 3 of therapy, compared to 54.6% of 500 mg treated patients (P = 0.006). Patients who started on 750 mg levofloxacin i.v. (N = 108) transitioned to p.o. in an average of 2.68 days while those starting on 500 mg i.v. (N = 124) transitioned in 2.95 days (P = 0.144). The median time for i.v.-to-p.o. switch was 2.35 days and 2.75 days for patients receiving 750 mg and 500 mg levofloxacin, respectively (P = 0.098, log rank test). By Day 3 of therapy, 68% of patients receiving the 750 mg dose had transitioned from i.v. to p.o. levofloxacin, compared with 61% of the 500 mg group (P = 0.280). The safety profiles were comparable for the two regimens. CONCLUSIONS: The 750 mg levofloxacin dose resulted in a greater proportion of patients with resolution of CAP symptoms by Day 3 when compared with 500 mg therapy. Consequently, the 750 mg regimen trended toward more rapid transition to p.o., potentially resulting in lower overall drug costs. Time to switch from i.v. to p.o. was determined by the investigators' discretion rather than a set protocol. Additionally, length of stay data was not collected in this study, which can significantly impact overall healthcare costs. Further research is required to fully understand the economic impact of the 750 mg, 5-day levofloxacin regimen.
Identifier
An unambiguous reference to the resource within a given context
<a href="http://doi.org/10.1185/030079904X2556" target="_blank" rel="noreferrer noopener">10.1185/030079904X2556</a>
Rights
Information about rights held in and over the resource
Article information provided for research and reference use only. All rights are retained by the journal listed under publisher and/or the creator(s).
*Levofloxacin
2004
Administration
Adult
Anti-Bacterial Agents/*administration & dosage/economics
Bacterial/*drug therapy
Community-Acquired Infections/drug therapy
Current medical research and opinion
Department of Internal Medicine
Drug Administration Schedule
Drug Costs
Female
File Thomas M Jr
Humans
Infusions
Intravenous
Khashab Mohammed M
Male
Milkovich Gary
NEOMED College of Medicine
Ofloxacin/*administration & dosage/economics
Oral
Pneumonia
Tennenberg Alan M
Treatment Outcome
Xiang Jim X
Zadeikis Neringa
-
Text
A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text.
URL Address
<a href="http://doi.org/10.1128/AAC.03643-14" target="_blank" rel="noreferrer noopener">http://doi.org/10.1128/AAC.03643-14</a>
Pages
1119–1126
Issue
2
Volume
59
Dublin Core
The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/.
Title
A name given to the resource
Assessment of time to clinical response, a proxy for discharge readiness, among hospitalized patients with community-acquired pneumonia who received either ceftaroline fosamil or ceftriaxone in two phase III FOCUS trials.
Publisher
An entity responsible for making the resource available
Antimicrobial agents and chemotherapy
Date
A point or period of time associated with an event in the lifecycle of the resource
2015
2015-02
Subject
The topic of the resource
Adult; Aged; Anti-Bacterial Agents/*therapeutic use; Bacterial/*drug therapy; Ceftriaxone/*therapeutic use; Cephalosporins/*therapeutic use; Community-Acquired Infections/*drug therapy; Female; Humans; Male; Middle Aged; Pneumonia; Treatment Outcome
Creator
An entity primarily responsible for making the resource
Lodise Thomas P; Anzueto Antonio R; Weber David J; Shorr Andrew F; Yang Min; Smith Alexander; Zhao Qi; Huang Xingyue; File Thomas M
Description
An account of the resource
The primary driver of health care costs for patients with community-acquired pneumonia (CAP) is the hospital length of stay (LOS). Unfortunately, hospital LOS comparisons are difficult to make from phase III CAP trials because of their structured designs and prespecified treatment durations. However, an opportunity still exists to draw inferences about potential LOS differences between treatments through the use of surrogates for hospital discharge. The intent of this study was to quantify the time to a clinical response, a proxy for the time to discharge readiness, among hospitalized CAP patients who received either ceftaroline or ceftriaxone in two phase III CAP FOCUS clinical trials. On the basis of the Infectious Diseases Society of America and American Thoracic Society CAP management guidelines and recent FDA guidance documents for community-acquired bacterial pneumonia, a post hoc adjudication algorithm was constructed a priori to compare the time to a clinical response, a proxy for the time to discharge readiness, between patients who received ceftaroline or ceftriaxone. Overall, 1,116 patients (ceftaroline, n=562; ceftriaxone, n=554) from the pooled FOCUS trials met the selection criteria for this analysis. Kaplan-Meier analyses showed that ceftaroline was associated with a shorter time, measured in days, to meeting the clinical response criteria (P=0.03). Of the patients on ceftaroline, 61.0, 76.1, and 83.6% achieved a clinical response by days 3, 4, and 5, compared to 54.3, 69.8, and 79.3% of the ceftriaxone-treated patients. In the Cox regression, ceftaroline was associated with a shorter time to a clinical response (HR, 1.16, P=0.02). The methodology employed here provides a framework to draw comparative effectiveness inferences from phase III CAP efficacy trials. (The FOCUS trials whose data were analyzed in this study have been registered at ClinicalTrials.gov under registration no. NCT00621504 and NCT00509106.).
Identifier
An unambiguous reference to the resource within a given context
<a href="http://doi.org/10.1128/AAC.03643-14" target="_blank" rel="noreferrer noopener">10.1128/AAC.03643-14</a>
Rights
Information about rights held in and over the resource
Article information provided for research and reference use only. All rights are retained by the journal listed under publisher and/or the creator(s).
2015
Adult
Aged
Anti-Bacterial Agents/*therapeutic use
Antimicrobial agents and chemotherapy
Anzueto Antonio R
Bacterial/*drug therapy
Ceftriaxone/*therapeutic use
Cephalosporins/*therapeutic use
Community-Acquired Infections/*drug therapy
Department of Internal Medicine
Female
File Thomas M
Huang Xingyue
Humans
Lodise Thomas P
Male
Middle Aged
NEOMED College of Medicine
Pneumonia
Shorr Andrew F
Smith Alexander
Treatment Outcome
Weber David J
Yang Min
Zhao Qi
-
Text
A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text.
URL Address
<a href="http://doi.org/10.1093/jac/dkv415" target="_blank" rel="noreferrer noopener">http://doi.org/10.1093/jac/dkv415</a>
Pages
862–870
Issue
4
Volume
71
Dublin Core
The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/.
Title
A name given to the resource
Ceftaroline fosamil versus ceftriaxone for the treatment of community-acquired pneumonia: individual patient data meta-analysis of randomized controlled trials.
Publisher
An entity responsible for making the resource available
The Journal of antimicrobial chemotherapy
Date
A point or period of time associated with an event in the lifecycle of the resource
2016
2016-04
Subject
The topic of the resource
Anti-Bacterial Agents/*therapeutic use; Bacterial/*drug therapy; Ceftriaxone/*therapeutic use; Cephalosporins/*therapeutic use; Community-Acquired Infections/*drug therapy; Humans; Pneumonia; Randomized Controlled Trials as Topic
Creator
An entity primarily responsible for making the resource
Taboada Maria; Melnick David; Iaconis Joseph P; Sun Fang; Zhong Nan Shan; File Thomas M; Llorens Lily; Friedland H David; Wilson David
Description
An account of the resource
BACKGROUND: We conducted a meta-analysis of clinical trials of adults hospitalized with pneumonia outcomes research team (PORT) risk class 3-4 community-acquired pneumonia (CAP) receiving ceftaroline fosamil versus ceftriaxone. METHODS: Three Phase III trials (clinicaltrials.gov registration numbers NCT00621504, NCT00509106 and NCT01371838) including 1916 hospitalized patients with CAP randomized 1:1 to empirical ceftaroline fosamil (600 mg every 12 h) or ceftriaxone (1-2 g every 24 h) for 5-7 days were included in the meta-analysis. Primary outcome was clinical response at the test-of-cure visit (8-15 days after end of treatment) in the PORT risk class 3-4 modified ITT (MITT) and clinically evaluable (CE) populations. Data were tested for heterogeneity (chi(2) test) and, if not significant, results were pooled and OR and 95% CI constructed. A logistic regression analysis assessed factors impacting cure rate and treatment interactions. RESULTS: Clinical cure rates in each trial consistently favoured ceftaroline fosamil versus ceftriaxone, with no evidence of heterogeneity. In the meta-analysis, ceftaroline fosamil was superior to ceftriaxone in the MITT (OR: 1.66; 95% CI 1.34, 2.06; P \textless 0.001) and CE (OR: 1.65; 95% CI 1.26, 2.16; P \textless 0.001) populations. Results were consistent across various patient- and disease-related factors including patients' age and PORT score. Prior antimicrobial use within 96 h of starting study treatment was associated with diminished differences in cure rates between treatments. CONCLUSIONS: Ceftaroline fosamil was superior to ceftriaxone for empirical treatment of adults hospitalized with CAP. Receipt of prior antimicrobial therapy appeared to diminish the observed treatment effect.
Identifier
An unambiguous reference to the resource within a given context
<a href="http://doi.org/10.1093/jac/dkv415" target="_blank" rel="noreferrer noopener">10.1093/jac/dkv415</a>
Rights
Information about rights held in and over the resource
Article information provided for research and reference use only. All rights are retained by the journal listed under publisher and/or the creator(s).
2016
Anti-Bacterial Agents/*therapeutic use
Bacterial/*drug therapy
Ceftriaxone/*therapeutic use
Cephalosporins/*therapeutic use
Community-Acquired Infections/*drug therapy
Department of Internal Medicine
File Thomas M
Friedland H David
Humans
Iaconis Joseph P
Llorens Lily
Melnick David
NEOMED College of Medicine
Pneumonia
Randomized Controlled Trials as Topic
Sun Fang
Taboada Maria
The Journal of antimicrobial chemotherapy
Wilson David
Zhong Nan Shan
-
Text
A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text.
URL Address
<a href="http://doi.org/10.1093/jac/dkr096" target="_blank" rel="noreferrer noopener">http://doi.org/10.1093/jac/dkr096</a>
Pages
iii19–32
Volume
66 Suppl 3
Dublin Core
The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/.
Title
A name given to the resource
FOCUS 1: a randomized, double-blinded, multicentre, Phase III trial of the efficacy and safety of ceftaroline fosamil versus ceftriaxone in community-acquired pneumonia.
Publisher
An entity responsible for making the resource available
The Journal of antimicrobial chemotherapy
Date
A point or period of time associated with an event in the lifecycle of the resource
2011
2011-04
Subject
The topic of the resource
80 and over; 80 and Over; Aged; Bacteria; Bacteria/isolation & purification; Bacterial – Drug Therapy; Bacterial/*drug therapy; Ceftriaxone – Administration and Dosage; Ceftriaxone – Adverse Effects; Ceftriaxone/administration & dosage/adverse effects; Cephalosporins – Administration and Dosage; Cephalosporins – Adverse Effects; Cephalosporins/*administration & dosage/*adverse effects; Community-Acquired Infections – Drug Therapy; Community-Acquired Infections/*drug therapy; Double-Blind Method; Double-Blind Studies; Female; Human; Humans; Infusions; Intravenous; Male; Middle Age; Middle Aged; Pneumonia; Randomized Controlled Trials; Treatment Outcome; Treatment Outcomes
Creator
An entity primarily responsible for making the resource
File Thomas M Jr; Low Donald E; Eckburg Paul B; Talbot George H; Friedland H David; Lee Jon; Llorens Lily; Critchley Ian A; Thye Dirk A
Description
An account of the resource
OBJECTIVES: Ceftaroline, the active form of the prodrug ceftaroline fosamil, is a novel cephalosporin with bactericidal activity against important pathogens associated with community-acquired pneumonia (CAP), including Streptococcus pneumoniae and common Gram-negative pathogens. FOCUS 1 is a randomized, double-blinded, Phase III study that was conducted to evaluate the efficacy and safety of ceftaroline fosamil in treating patients with CAP. The primary objective was to determine non-inferiority [lower limit of 95% confidence interval (CI) \textgreater/= -10%] in clinical cure rates achieved with ceftaroline fosamil compared with those achieved with ceftriaxone in the clinically evaluable (CE) and modified intent-to-treat efficacy (MITTE) populations. METHODS: Patients hospitalized in a non-intensive care unit setting with CAP of Pneumonia Outcomes Research Team (PORT) risk class III or IV requiring intravenous (iv) therapy were randomized (1:1) to receive 600 mg of ceftaroline fosamil iv every 12 h or 1 g of ceftriaxone iv every 24 h. Patients also received two 500 mg doses of oral clarithromycin every 12 h administered on day 1. Clinical cure, microbiological response, adverse events (AEs) and laboratory tests were assessed. FOCUS 1 registration number NCT00621504 (http://clinicaltrials.gov/ct2/show/NCT00621504). RESULTS: Of 613 enrolled patients, 298 received ceftaroline fosamil and 308 received ceftriaxone. Baseline characteristics between treatment groups were comparable. Clinical cure rates were as follows: CE population, 86.6% (194/224) for ceftaroline fosamil and 78.2% (183/234) for ceftriaxone [difference (95% CI), 8.4% (1.4, 15.4)]; and MITTE population, 83.8% (244/291) for ceftaroline fosamil and 77.7% (233/300) for ceftriaxone [difference (95% CI), 6.2% (-0.2, 12.6)]. Clinical cure rates for CAP caused by S. pneumoniae in the microbiological MITTE population were 88.9% (24/27) and 66.7% (20/30) for ceftaroline fosamil and ceftriaxone, respectively. Both agents were well tolerated, with similar rates of AEs, serious AEs, deaths and discontinuations because of an AE. The most common AEs for ceftaroline fosamil-treated patients were diarrhoea, headache, insomnia and nausea, and the most common AEs for ceftriaxone-treated patients were hypokalaemia, hypertension, nausea and diarrhoea. CONCLUSIONS: Ceftaroline fosamil demonstrated high clinical cure and microbiological response rates in hospitalized patients with CAP of PORT risk class III or IV. Ceftaroline fosamil was well tolerated, with a safety profile similar to that of ceftriaxone and consistent with the cephalosporin class. In this study, ceftaroline fosamil was an effective and well-tolerated treatment option for CAP.
Identifier
An unambiguous reference to the resource within a given context
<a href="http://doi.org/10.1093/jac/dkr096" target="_blank" rel="noreferrer noopener">10.1093/jac/dkr096</a>
Rights
Information about rights held in and over the resource
Article information provided for research and reference use only. All rights are retained by the journal listed under publisher and/or the creator(s).
2011
80 and over
Aged
Bacteria
Bacteria/isolation & purification
Bacterial – Drug Therapy
Bacterial/*drug therapy
Ceftriaxone – Administration and Dosage
Ceftriaxone – Adverse Effects
Ceftriaxone/administration & dosage/adverse effects
Cephalosporins – Administration and Dosage
Cephalosporins – Adverse Effects
Cephalosporins/*administration & dosage/*adverse effects
Community-Acquired Infections – Drug Therapy
Community-Acquired Infections/*drug therapy
Critchley Ian A
Department of Internal Medicine
Double-Blind Method
Double-Blind Studies
Eckburg Paul B
Female
File Thomas M Jr
Friedland H David
Human
Humans
Infusions
Intravenous
Lee Jon
Llorens Lily
Low Donald E
Male
Middle Age
Middle Aged
NEOMED College of Medicine
Pneumonia
RANDOMIZED controlled trials
Talbot George H
The Journal of antimicrobial chemotherapy
Thye Dirk A
Treatment Outcome
Treatment Outcomes
-
Text
A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text.
URL Address
<a href="http://doi.org/10.1086/657313" target="_blank" rel="noreferrer noopener">http://doi.org/10.1086/657313</a>
Pages
1395–1405
Issue
12
Volume
51
Dublin Core
The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/.
Title
A name given to the resource
Integrated analysis of FOCUS 1 and FOCUS 2: randomized, doubled-blinded, multicenter phase 3 trials of the efficacy and safety of ceftaroline fosamil versus ceftriaxone in patients with community-acquired pneumonia.
Publisher
An entity responsible for making the resource available
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
Date
A point or period of time associated with an event in the lifecycle of the resource
2010
2010-12
Subject
The topic of the resource
80 and over; Administration; Adult; Aged; Anti-Bacterial Agents/*administration & dosage/*adverse effects; Bacterial/*drug therapy; Ceftriaxone/*administration & dosage/*adverse effects; Cephalosporins/*administration & dosage/*adverse effects; Community-Acquired Infections/drug therapy; Double-Blind Method; Female; Humans; Infusions; Intravenous; Male; Middle Aged; Oral; Pneumonia; Treatment Outcome
Creator
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File Thomas M Jr; Low Donald E; Eckburg Paul B; Talbot George H; Friedland H David; Lee Jon; Llorens Lily; Critchley Ian; Thye Dirk
Description
An account of the resource
BACKGROUND: Ceftaroline, the active form of ceftaroline fosamil, is a broad-spectrum cephalosporin with bactericidal activity against pathogens causing community-acquired pneumonia (CAP), including Streptococcus pneumoniae. Ceftaroline was evaluated for the treatment of CAP in 2 randomized, double-blind, multicenter trials: Ceftaroline Community Acquired Pneumonia Trial versus Ceftriaxone in Hospitalized Patients (FOCUS) 1 and FOCUS 2. METHODS: Patients hospitalized (but not admitted to an intensive care unit) with Pneumonia Outcomes Research Team risk class III or IV CAP requiring intravenous therapy were randomized to ceftaroline 600 mg every 12 h or ceftriaxone 1 g every 24 h for 5-7 days. Patients in FOCUS 1 received 2 doses of oral clarithromycin 500 mg every 12 h on day 1. RESULTS: In the individual trials, clinical cure rates in the clinically evaluable (CE) population for ceftaroline versus ceftriaxone were as follows: FOCUS 1, 86.6% vs 78.2% (difference, 8.4%; 95% confidence interval [CI], 1.4%-15.4%); FOCUS 2, 82.1% vs 77.2% (difference, 4.9%; 95% CI, -2.5% to 12.5%). In the integrated analysis, 614 patients received ceftaroline and 614 received ceftriaxone. Of the CE patients treated with ceftaroline, 84.3% achieved clinical cure, compared with 77.7% of ceftriaxone-treated patients (difference, 6.7%; 95% CI, 1.6%-11.8%). Clinical cure rates in the modified intent-to-treat efficacy population were 82.6% versus 76.6% for ceftaroline and ceftriaxone (difference, 6.0%; 95% CI, 1.4%-10.7%). Ceftaroline and ceftriaxone were well tolerated; rates of adverse events, serious adverse events, deaths, and premature discontinuations caused by an adverse event were similar in both treatment arms. CONCLUSIONS: Ceftaroline was noninferior to ceftriaxone in the individual trials. In this integrated analysis, clinical cure rates for the ceftaroline group were numerically higher than those for the ceftriaxone group. Ceftaroline was well tolerated, with a safety profile similar to that of ceftriaxone.
Identifier
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<a href="http://doi.org/10.1086/657313" target="_blank" rel="noreferrer noopener">10.1086/657313</a>
Rights
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Article information provided for research and reference use only. All rights are retained by the journal listed under publisher and/or the creator(s).
2010
80 and over
Administration
Adult
Aged
Anti-Bacterial Agents/*administration & dosage/*adverse effects
Bacterial/*drug therapy
Ceftriaxone/*administration & dosage/*adverse effects
Cephalosporins/*administration & dosage/*adverse effects
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
Community-Acquired Infections/drug therapy
Critchley Ian
Department of Internal Medicine
Double-Blind Method
Eckburg Paul B
Female
File Thomas M Jr
Friedland H David
Humans
Infusions
Intravenous
Lee Jon
Llorens Lily
Low Donald E
Male
Middle Aged
NEOMED College of Medicine
Oral
Pneumonia
Talbot George H
Thye Dirk
Treatment Outcome
-
Text
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URL Address
<a href="http://doi.org/10.1016/j.ijantimicag.2017.01.043" target="_blank" rel="noreferrer noopener">http://doi.org/10.1016/j.ijantimicag.2017.01.043</a>
Pages
247–251
Issue
2
Volume
50
Dublin Core
The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/.
Title
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Macrolide therapy for community-acquired pneumonia due to atypical pathogens: outcome assessment at an early time point.
Publisher
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International journal of antimicrobial agents
Date
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2017
2017-08
Subject
The topic of the resource
80 and over; Adult; Aged; Anti-Bacterial Agents/adverse effects/*therapeutic use; Atypical pathogen; Bacterial/*drug therapy; Ceftaroline fosamil; Ceftriaxone/adverse effects/*therapeutic use; Cephalosporins/adverse effects/*therapeutic use; Chlamydial Pneumonia; Chlamydophila pneumoniae; Clinical Trials; Combination/adverse effects/methods; Community-Acquired Infections/*drug therapy; Community-acquired pneumonia; Double-Blind Method; Drug Therapy; Female; Humans; Legionella pneumophila; Macrolide; Macrolides/adverse effects/*therapeutic use; Male; Middle Aged; Mycoplasma; Mycoplasma pneumoniae; Phase III as Topic; Pneumonia; Randomized Controlled Trials as Topic; Time Factors; Treatment Outcome
Creator
An entity primarily responsible for making the resource
File Thomas M Jr; Eckburg Paul B; Talbot George H; Llorens Lily; Friedland H David
Description
An account of the resource
BACKGROUND: Therapy directed against atypical pathogens in patients with community-acquired pneumonia (CAP) is often recommended. This post-hoc analysis evaluated the effect of addition of a macrolide to ceftaroline fosamil or ceftriaxone treatment in atypical CAP. METHODS: Two phase 3, double-blind, comparative safety and efficacy studies of ceftaroline fosamil vs. ceftriaxone, FOCUS 1 and FOCUS 2, enrolled adults with CAP. Only FOCUS 1 included 24-h adjunctive clarithromycin therapy for all patients on day 1. Day 4 and test-of-cure (TOC) outcomes were compared for adjunctive vs. no adjunctive therapy. RESULTS: Of 1240 enrolled patients, 130 patients with CAP due to atypical pathogens alone were included (FOCUS 1, n = 64; FOCUS 2, n = 66). Among patients infected with Mycoplasma pneumoniae and/or Chlamydophila pneumoniae alone, a higher clinical response rate was observed with clarithromycin plus ceftaroline fosamil or ceftriaxone compared with treatment without additional clarithromycin at day 4 [38/49 (77.6%; FOCUS 1) vs. 24/43 (55.8%; FOCUS 2)], but not at the TOC assessment [42/49 (85.7%; FOCUS 1) vs. 41/43 (95.3%; FOCUS 2)]. In patients infected with Legionella pneumophila alone, a higher clinical response rate with adjunctive clarithromycin therapy was observed at the TOC assessment alone [12/12 (100%; FOCUS 1) vs. 14/19 (73.7%; FOCUS 2)]. The unadjusted odds ratio of a favourable clinical response at day 4 with adjunctive clarithromycin vs. no adjunctive clarithromycin was 2.4 (95% confidence interval 1.1-5.1; P = 0.0299) for all pathogens combined. CONCLUSIONS: These results suggest that empirical antibiotic therapy against atypical pathogens may improve early clinical response rate. This hypothesis is best evaluated in a prospective trial.
Identifier
An unambiguous reference to the resource within a given context
<a href="http://doi.org/10.1016/j.ijantimicag.2017.01.043" target="_blank" rel="noreferrer noopener">10.1016/j.ijantimicag.2017.01.043</a>
Rights
Information about rights held in and over the resource
Article information provided for research and reference use only. All rights are retained by the journal listed under publisher and/or the creator(s).
2017
80 and over
Adult
Aged
Anti-Bacterial Agents/adverse effects/*therapeutic use
Atypical pathogen
Bacterial/*drug therapy
Ceftaroline fosamil
Ceftriaxone/adverse effects/*therapeutic use
Cephalosporins/adverse effects/*therapeutic use
Chlamydial Pneumonia
Chlamydophila pneumoniae
Clinical Trials
Combination/adverse effects/methods
Community-Acquired Infections/*drug therapy
Community-acquired pneumonia
Department of Internal Medicine
Double-Blind Method
Drug Therapy
Eckburg Paul B
Female
File Thomas M Jr
Friedland H David
Humans
International journal of antimicrobial agents
Legionella pneumophila
Llorens Lily
Macrolide
Macrolides/adverse effects/*therapeutic use
Male
Middle Aged
Mycoplasma
Mycoplasma pneumoniae
NEOMED College of Medicine
Phase III as Topic
Pneumonia
Randomized Controlled Trials as Topic
Talbot George H
Time Factors
Treatment Outcome