1
40
1
-
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/cid/ciw490" target="_blank" rel="noreferrer noopener">http://doi.org/10.1093/cid/ciw490</a>
Pages
1007–1016
Issue
8
Volume
63
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
SOLITAIRE-IV: A Randomized, Double-Blind, Multicenter Study Comparing the Efficacy and Safety of Intravenous-to-Oral Solithromycin to Intravenous-to-Oral Moxifloxacin for Treatment of Community-Acquired Bacterial 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
2016
2016-10
Subject
The topic of the resource
*clinical trial; *community-acquired; *pneumonia; *solithromycin; *Streptococcus pneumoniae; 80 and over; Administration; Adult; Aged; Anti-Bacterial Agents/*administration & dosage/adverse effects; Bacterial; Bacterial/diagnosis/*drug therapy/*microbiology; Community-Acquired Infections/diagnosis/*drug therapy/*microbiology; Comorbidity; Drug Resistance; Female; Fluoroquinolones/*administration & dosage/adverse effects; Humans; Intravenous; Macrolides/*administration & dosage/adverse effects; Male; Microbial Sensitivity Tests; Middle Aged; Moxifloxacin; Oral; Pneumonia; Treatment Outcome; Triazoles/*administration & dosage/adverse effects
Creator
An entity primarily responsible for making the resource
File Thomas M Jr; Rewerska Barbara; Vucinic-Mihailovic Violeta; Gonong Joven Roque V; Das Anita F; Keedy Kara; Taylor David; Sheets Amanda; Fernandes Prabhavathi; Oldach David; Jamieson Brian D
Description
An account of the resource
BACKGROUND: Solithromycin, a novel macrolide antibiotic with both intravenous and oral formulations dosed once daily, has completed 2 global phase 3 trials for treatment of community-acquired bacterial pneumonia. METHODS: A total of 863 adults with community-acquired bacterial pneumonia (Pneumonia Outcomes Research Team [PORT] class II-IV) were randomized 1:1 to receive either intravenous-to-oral solithromycin or moxifloxacin for 7 once-daily doses. All patients received 400 mg intravenously on day 1 and were permitted to switch to oral dosing when clinically indicated. The primary objective was to demonstrate noninferiority (10% margin) of solithromycin to moxifloxacin in achievement of early clinical response (ECR) assessed 3 days after first dose in the intent-to-treat (ITT) population. Secondary endpoints included demonstrating noninferiority in ECR in the microbiological ITT population (micro-ITT) and determination of investigator-assessed success rates at the short-term follow-up (SFU) visit 5-10 days posttherapy. RESULTS: In the ITT population, 79.3% of solithromycin patients and 79.7% of moxifloxacin patients achieved ECR (treatment difference, -0.46; 95% confidence interval [CI], -6.1 to 5.2). In the micro-ITT population, 80.3% of solithromycin patients and 79.1% of moxifloxacin patients achieved ECR (treatment difference, 1.26; 95% CI, -8.1 to 10.6). In the ITT population, 84.6% of solithromycin patients and 88.6% of moxifloxacin patients achieved clinical success at SFU based on investigator assessment. Mostly mild/moderate infusion events led to higher incidence of adverse events overall in the solithromycin group. Other adverse events were comparable between treatment groups. CONCLUSIONS: Intravenous-to-oral solithromycin was noninferior to intravenous-to-oral moxifloxacin. Solithromycin has potential to provide an intravenous and oral option for monotherapy for community-acquired bacterial pneumonia. CLINICAL TRIALS REGISTRATION: NCT01968733.
Identifier
An unambiguous reference to the resource within a given context
<a href="http://doi.org/10.1093/cid/ciw490" target="_blank" rel="noreferrer noopener">10.1093/cid/ciw490</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).
*clinical trial
*Community-acquired
*Pneumonia
*solithromycin
*Streptococcus pneumoniae
2016
80 and over
Administration
Adult
Aged
Anti-Bacterial Agents/*administration & dosage/adverse effects
Bacterial
Bacterial/diagnosis/*drug therapy/*microbiology
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
Community-Acquired Infections/diagnosis/*drug therapy/*microbiology
Comorbidity
Das Anita F
Department of Internal Medicine
Drug Resistance
Female
Fernandes Prabhavathi
File Thomas M Jr
Fluoroquinolones/*administration & dosage/adverse effects
Gonong Joven Roque V
Humans
Intravenous
Jamieson Brian D
Keedy Kara
Macrolides/*administration & dosage/adverse effects
Male
Microbial Sensitivity Tests
Middle Aged
Moxifloxacin
NEOMED College of Medicine
Oldach David
Oral
Pneumonia
Rewerska Barbara
Sheets Amanda
Taylor David
Treatment Outcome
Triazoles/*administration & dosage/adverse effects
Vucinic-Mihailovic Violeta