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NCT02563106 · ClinicalTrials.gov registry record · Phase 2
A Study of SYN-004 for the Prevention of C.Diff in Patients With a LRTI
A Phase 2 study, sponsored by Theriva Biologics.
- Completed
- Registry status
- Phase 2
- Development phase
- 413
- Enrollment target
NCT02563106: Completed Phase 2 study, sponsored by Theriva Biologics.
NCT02563106 is a Phase 2 study that has completed, run by Theriva Biologics. The registered enrollment target is 413 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (211% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02563106, a Phase 2 study, has completed, sponsored by Theriva Biologics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 413 participants
- Enrollment target
Study Summary
A Phase 2b Parallel-Group, Double-Blind, Placebo-Controlled, Multicenter Study of SYN-004 Compared to Placebo for the Prevention of Clostridium difficile Infection (CDI) in Hospitalized Patients receiving IV ceftriaxone with a Diagnosis of a Lower Respiratory Tract Infection (LRTI).
Primary Outcome
Percentage of subjects with CDI, based on the protocol definition of CDI (defined as 3 or more unformed stools per 24 hour period and a stool sample being positive for C. difficile toxin A and/or B \[or their respective genes, tcdA and/or tcdB\], based on the clinical site local laboratory results) from Day 1 to the 4-week Follow-up Visit in the SYN-004 treatment group compared to the placebo group, imputing early termination without CDI as not being treatment failures.
Interventions
- DRUG Placebo
- DRUG SYN-004
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 413 participants |
| Start Date | 2015-10 |
| Est. Completion | 2016-11 |
| Phase | Phase 2 |
What the finished NCT02563106 record still lists
NCT02563106 is an interventional study that assigns participants to a tested intervention. The registered 413 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 (211% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02563106 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02563106 about?
NCT02563106 is a clinical study titled "A Study of SYN-004 for the Prevention of C.Diff in Patients With a LRTI". A Phase 2b Parallel-Group, Double-Blind, Placebo-Controlled, Multicenter Study of SYN-004 Compared to Placebo for the Prevention of Clostridium difficile Infection (CDI) in Hospitalized Patients receiving IV ceftriaxone with a Diagnosis of a Lower Respiratory Tract Infection (LRTI).
What is the current status of trial NCT02563106?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 413 participants. The study started on 2015-10. Estimated completion is 2016-11.
What interventions are being tested in trial NCT02563106?
The interventions under investigation include: Placebo (DRUG), SYN-004 (DRUG).
Who is sponsoring clinical trial NCT02563106?
This trial is sponsored by Theriva Biologics, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02563106's enrollment target sits among peer trials
413 93rd of 2000 higher than 1,908 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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