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Full Title C. Diff
Protocol Number
Principal Investigator(s) Suresh K. Agarwal, Jr., MD, FACS, FCCM, FCCP
Division General Surgery
Status New
Description

Primary: To assess the effectiveness of treatment with SYN-004 for the prevention of Clostridium difficile (C. difficile) associated diarrhea (CDAD) in patients hospitalized for a lower respiratory tract infection receiving intravenous (IV) ceftriaxone alone or in combination with a macrolide.

To evaluate the safety and tolerability of SYN-004 in patients with a lower respiratory tract infection receiving ceftriaxone alone or in combination with a macrolide.

Secondary: To assess the effectiveness of treatment with SYN-004 for the prevention of antibiotic associated diarrhea (AAD) in patients hospitalized for a lower respiratory tract infection receiving IV ceftriaxone alone or in combination with a macrolide.

Primary endpoint
• Percentage of patients with CDAD based on the protocol definition of CDAD from Day 1 to the 4-week Follow-Up Visit in the SYN-004 treatment group compared to the placebo group
Secondary endpoints
• Percentage of patients with CDAD based on the protocol definition of CDAD from Day 1 to the 2-week Follow-Up Visit and 6-week Follow-Up Visit in the SYN-004 treatment group compared to the placebo group
• Percentage of patients treated for CDAD from Day 1 to the 4-week Follow-Up Visit and from Day 1 to the 6-week Follow-Up Visit in the SYN-004 treatment group compared to the placebo group
• Percentage of patients with AAD based on the protocol definition of AAD from Day 1 to the 2-, 4- and 6-week Follow-Up Visit in the SYN-004 treatment group compared to the placebo group
• Percentage of patients treated for AAD from Day 1 to the 4-week Follow-Up Visit and from Day 1 to the 6-week Follow-Up Visit in the SYN-004 treatment group compared to the placebo group.
• Comparison of SYN-004 and placebo treatment using a composite of the following clinical outcomes occurring throughout the study:
CDAD
AAD
− No diarrhea but colonization (change from baseline) by C. difficile
− No diarrhea but colonization (change from baseline) by VRE
Exploratory endpoints
• Change in stool colonization by
− C. difficile
VRE
ESBL-GNB
• Overall colonic microbiome changes in the

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