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

Completed · Phase 2 · Has a placebo group

Conditions studied: Clostridium Difficile, Clostridium Infections

In brief

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).

Key facts

Study ID

NCT02563106

Run by

Theriva Biologics, Inc.

People needed

413

Starts

2015-10-01

Expected to finish

2016-11-01

Last updated by the study team

2018-11-27

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Synthetic Biologics Investigational Site — Little Rock, Arkansas, United States
• Synthetic Biologics Investigational Site — Torrance, California, United States
• Synthetic Biologics Investigational Site — DeLand, Florida, United States
• Synthetic Biologics Investigational Site — Będzin, Louisiana, United States
• Synthetic Biologics Investigational Site — Debrecen, Louisiana, United States
• Synthetic Biologics Investigational SIte — Natchitoches, Louisiana, United States
• Synthetic Biologics Investigational Site — Gabrovo, Bulgaria
• Synthetic Biologics Investigational Site — Kyustendil, Bulgaria
• Synthetic Biologics Investigational Site — Lovech, Bulgaria
• Synthetic Biologics Investigational Site — Multiple Locations, Bulgaria
• Synthetic Biologics Investigational Site — Rousse, Bulgaria
• Synthetic Biologics Investigational Site — Sevlievo, Bulgaria
• Synthetic Biologics Investigational Site — Sofia, Bulgaria
• Synthetic Biologics Investigational Site — Targovishte, Bulgaria
• Synthetic Biologics Investigational Site — Sherbrooke, Canada
• Synthetic Biologics Investigational Site — Toronto, Canada
• Synthetic Biologics Investigational Site — Balassagyarmat, Hungary
• Synthetic Biologics Investigational Site — Budapest, Hungary
• Synthetic Biologics Investigational Site — Veszprém, Hungary
• Synthetic Biologics Investigational Site — Bialystok, Poland
• Synthetic Biologics Investigational Site — Bochnia, Poland
• Synthetic Biologics Investigational Site — Bydgoszcz, Poland
• Synthetic Biologics Investigational Site — Chodzież, Poland
• Synthetic Biologics Investigational Site — Lodz, Poland
• Synthetic Biologics Investigational Site — Oława, Poland

Full record on ClinicalTrials.gov

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