NCT02563106

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 413 (actual)
• Sponsor: Theriva Biologics, Inc. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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).

Detailed 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).

Conditions

• Clostridium Difficile
• Clostridium Infections

Interventions

Type	Name	Description
DRUG	SYN-004
DRUG	Placebo

Timeline

• Start date: 2015-10-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2015-09-29
• Last updated: 2018-11-27
• Results posted: 2018-03-12

Locations

43 sites across 7 countries: United States, Bulgaria, Canada, Hungary, Poland, Romania, Serbia