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Efficacy and Safety Study of Oral Solithromycin (CEM-101) Compared to Oral Moxifloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia
NCT01756339 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01756339
The ClinicalTrials.gov registry entry for NCT01756339 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 860 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Melinta Therapeutics, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01756339 reports 20 study locations spanning 9 distinct geographic areas — top geographies include California, Florida, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01756339?
The interventions under investigation include: Moxifloxacin (DRUG), Solithromycin (DRUG), Placebo to match solithromycin (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01756339?
This trial is sponsored by Melinta Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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