Overview

A Study of SYN-004 for the Prevention of C.Diff in Patients With a LRTI

Status:
Completed
Trial end date:
2016-11-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Synthetic Biologics Inc.
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.