Overview

This trial has been completed.

Conditions clostridium difficile, clostridium infections
Treatments syn-004, placebo
Phase phase 2
Sponsor Synthetic Biologics Inc.
Start date October 2015
End date November 2016
Trial size 413 participants
Trial identifier NCT02563106, SB-2-004-005

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose prevention
Arm
(Experimental)
SYN-004 150 mg
syn-004
(Placebo Comparator)
Matching placebo
placebo

Primary Outcomes

Measure
Percentage of patients with CDAD
time frame: 4 weeks

Eligibility Criteria

Male or female participants at least 50 years old.

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.

Additional Information

Official title A Double-Blind, Placebo-Controlled, Multicenter Study of SYN-004 Compared to Placebo for the Prevention of C.Diff in Patients With a Diagnosis of a Lower Respiratory Tract Infection
Description This is a Phase 2b, randomized, double-blind, placebo controlled, parallel-group, multi-center proof-of-concept study to assess the potential of SYN-004 in the prevention of CDI and the unwanted side effects of IV antibiotic treatment in at risk patients who are hospitalized for LRTI and receiving IV ceftriaxone alone or in combination with a macrolide. Subjects will be 50 years or older. The entire duration of the study may be up to 59 days. All patients will be evaluated for the occurrence of CDI and AAD by testing according to local diagnostic standards and monitoring for diarrhea (3 or more unformed stools per 24 hour period).
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Synthetic Biologics Inc..