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NCT01756339 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of Oral Solithromycin (CEM-101) Compared to Oral Moxifloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia
A Phase 3 study of Community-acquired Bacterial Pneumonia, sponsored by Melinta Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 860
- Enrollment target
- 20
- Study locations
NCT01756339: Completed Phase 3 study of Community-acquired Bacterial Pneumonia, sponsored by Melinta Therapeutics.
NCT01756339 is a Phase 3 study of Community-acquired Bacterial Pneumonia that has completed, run by Melinta Therapeutics. The registered enrollment target is 860 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (11% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01756339, a Phase 3 study of Community-acquired Bacterial Pneumonia, has completed, sponsored by Melinta Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 860 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will evaluate the safety and efficacy of an experimental antibiotic, solithromycin, in the treatment of adult patients with community-acquired pneumonia.
Primary Outcome
To determine noninferiority (NI) in early clinical response rate, in at least 2 of the following 4 cardinal symptoms: cough, shortness of breath, chest pain, and sputum production.
Conditions Studied
Interventions
- DRUG Moxifloxacin
- DRUG Solithromycin
- OTHER Placebo to match solithromycin
Study Locations (20)
California
- - Glendale
- - Los Angeles
- - Mission Hills
- - Oxnard
- - Pasadena
- - Sylmar
- - Torrance
Florida
- - DeBary
- - DeLand
- - Miami
- - Miami
- - Saint Cloud
- - Tampa
Georgia
- - Duluth
Massachusetts
- - New Bedford
Montana
- - Butte
Ohio
- - Columbus
Pennsylvania
- - Downingtown
South Carolina
- - Summerville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 860 participants |
| Start Date | 2012-12 |
| Est. Completion | 2014-10 |
| Phase | Phase 3 |
What the finished NCT01756339 record still lists
NCT01756339 is an interventional study that assigns participants to a tested intervention. The registered 860 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (11% higher).
The record links to 1 condition, with Community-acquired Bacterial Pneumonia appearing as the primary indexed condition, and to 3 interventions - of which Moxifloxacin is the first listed.
NCT01756339 names 20 study sites across 9 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT01756339 about?
NCT01756339 is a clinical study titled "Efficacy and Safety Study of Oral Solithromycin (CEM-101) Compared to Oral Moxifloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia". This study will evaluate the safety and efficacy of an experimental antibiotic, solithromycin, in the treatment of adult patients with community-acquired pneumonia.
What is the current status of trial NCT01756339?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 860 participants. The study started on 2012-12. Estimated completion is 2014-10.
What conditions does trial NCT01756339 study?
This clinical trial studies the following conditions: Community-acquired Bacterial Pneumonia.
What interventions are being tested in trial NCT01756339?
The interventions under investigation include: Moxifloxacin (DRUG), Solithromycin (DRUG), Placebo to match solithromycin (OTHER).
Who is sponsoring clinical trial NCT01756339?
This trial is sponsored by Melinta Therapeutics, which has 31 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01756339 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Massachusetts, Montana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01756339's enrollment target sits among peer trials
860 380th of 2000 higher than 1,618 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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