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NCT01968733 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of Intravenous to Oral Solithromycin (CEM-101) Compared to Intravenous to Oral Moxifloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia
A Phase 3 study, sponsored by Melinta Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 863
- Enrollment target
NCT01968733: Completed Phase 3 study, sponsored by Melinta Therapeutics.
NCT01968733 is a Phase 3 study that has completed, run by Melinta Therapeutics. The registered enrollment target is 863 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (12% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01968733, a Phase 3 study, has completed, sponsored by Melinta Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 863 participants
- Enrollment target
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
Interventions
- DRUG Moxifloxacin
- DRUG Solithromycin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 863 participants |
| Start Date | 2013-11 |
| Est. Completion | 2015-09 |
| Phase | Phase 3 |
What the finished NCT01968733 record still lists
NCT01968733 is an interventional study that assigns participants to a tested intervention. The registered 863 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 (12% higher).
The record links to 0 conditions, and to 2 interventions - of which Moxifloxacin is the first listed.
NCT01968733 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01968733 about?
NCT01968733 is a clinical study titled "Efficacy and Safety Study of Intravenous to Oral Solithromycin (CEM-101) Compared to Intravenous 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 NCT01968733?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 863 participants. The study started on 2013-11. Estimated completion is 2015-09.
What interventions are being tested in trial NCT01968733?
The interventions under investigation include: Moxifloxacin (DRUG), Solithromycin (DRUG).
Who is sponsoring clinical trial NCT01968733?
This trial is sponsored by Melinta Therapeutics, which has 31 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01968733's enrollment target sits among peer trials
863 380th of 2000 higher than 1,621 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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