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NCT02903836 · ClinicalTrials.gov registry record · Phase 2
Phase II Study of Oral Nafithromycin in CABP
A Phase 2 study of Community-Acquired Bacterial Pneumonia (CABP), sponsored by Wockhardt.
- Completed
- Registry status
- Phase 2
- Development phase
- 231
- Enrollment target
- 6
- Study locations
NCT02903836: Completed Phase 2 study of Community-Acquired Bacterial Pneumonia (CABP), sponsored by Wockhardt.
NCT02903836 is a Phase 2 study of Community-Acquired Bacterial Pneumonia (CABP) that has completed, run by Wockhardt. The registered enrollment target is 231 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% higher). The trial reports 6 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02903836, a Phase 2 study of Community-Acquired Bacterial Pneumonia (CABP), has completed, sponsored by Wockhardt.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 231 participants
- Enrollment target
- 6
- Study locations
Study Summary
Study to Determine the Safety, Tolerability, Pharmacokinetics and Efficacy of Oral Nafithromycin Versus Oral Moxifloxacin in the Treatment of Community-Acquired Bacterial Pneumonia (CABP) in Adults
Primary Outcome
The primary efficacy endpoint was clinical response (response, non-response, or indeterminate) at Day 4, tested in the ITT population. Clinical response was determined programmatically using the investigator's assessment of CABP symptoms entered into the eCRF. The severity of the subject CABP symptoms of dyspnea (shortness of breath), cough, production of purulent sputum, and pleuritic chest pain were evaluated on a 4-point scale (absent, mild, moderate, or severe) based upon the CABP Symptom Se
Conditions Studied
Interventions
- DRUG Nafithromycin 800 mg 3 days
- DRUG Nafithromycin 800 mg 5 days
- DRUG Moxifloxacin 400 mg
Study Locations (6)
Florida
- A & L Clinical research - Miami
- A Plus Research Inc. - Miami
- RM Medical Research, Inc. - Miami
- Empire Clinical Research, LLC - Miami Lakes
Massachusetts
- HCI Metromedic Walkin Medical Center - Bedford
South Dakota
- Health Concepts - Bedford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 231 participants |
| Start Date | 2016-11-18 |
| Est. Completion | 2017-07-08 |
| Phase | Phase 2 |
What the finished NCT02903836 record still lists
NCT02903836 is an interventional study that assigns participants to a tested intervention. The registered 231 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% higher).
The record links to 1 condition, with Community-Acquired Bacterial Pneumonia (CABP) appearing as the primary indexed condition, and to 3 interventions - of which Nafithromycin 800 mg 3 days is the first listed.
NCT02903836 lists 6 locations in 3 states (Florida, Massachusetts, South Dakota).
Frequently Asked Questions
What is clinical trial NCT02903836 about?
NCT02903836 is a clinical study titled "Phase II Study of Oral Nafithromycin in CABP". Study to Determine the Safety, Tolerability, Pharmacokinetics and Efficacy of Oral Nafithromycin Versus Oral Moxifloxacin in the Treatment of Community-Acquired Bacterial Pneumonia (CABP) in Adults
What is the current status of trial NCT02903836?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 231 participants. The study started on 2016-11-18. Estimated completion is 2017-07-08.
What conditions does trial NCT02903836 study?
This clinical trial studies the following conditions: Community-Acquired Bacterial Pneumonia (CABP).
What interventions are being tested in trial NCT02903836?
The interventions under investigation include: Nafithromycin 800 mg 3 days (DRUG), Nafithromycin 800 mg 5 days (DRUG), Moxifloxacin 400 mg (DRUG).
Who is sponsoring clinical trial NCT02903836?
This trial is sponsored by Wockhardt, which has 27 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02903836 being conducted?
This trial has 6 study locations across Florida, Massachusetts, South Dakota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02903836's enrollment target sits among peer trials
231 257th of 2000 higher than 1,744 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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