Phase 2
Completed N=413
A Study of SYN-004 for the Prevention of C.Diff in Patients With a LRTI
Clostridium Difficile · Clostridium Infections
Source: ClinicalTrials.gov NCT02563106 ↗
Enrolled (actual)
413
Serious AEs
13.1%
Results posted
Mar 2018
Primary outcomePrimary: Percentage of Patients With Clostridium Difficile Infection at 4- Weeks of Follow-up. — 2; 7 Participants — p=0.045
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With Clostridium Difficile Infection at 4- Weeks of Follow-up. |
2; 7 | 0.045 sig |
Eligibility Criteria
Inclusion Criteria
- Expected minimum hospital stay of 5 days
- Expected ≥5 day course of intravenous (IV) ceftriaxone alone or in combination with a macrolide
- Clinical diagnosis of moderate to severe lower respiratory tract infection consisting of signs and symptoms of a lower respiratory tract infection and Pneumonia Severity Index (PSI/PORT) score for CAP of 90-130, inclusive. Evidence of a new or progressive infiltrate on chest x-ray is recommended.
Exclusion Criteria
- Presence of a diarrheal illness within 72 hours prior to randomization
- Current treatment for CDAD or ongoing active CDI, as evidenced by clinical signs of diarrhea along with the presence of toxin A and/or B (or their respective genes, tcdA and/or tcdB) of C. difficile in the stool
- Number of previous CDAD episodes >1 within 12 weeks of randomization and no C. difficile infection (CDI) within 4 weeks of randomization
- Use of antibiotics within 1 month of start of study drug except for the current illness.
Data sourced from ClinicalTrials.gov (NCT02563106). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.