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

• ClinicalTrials.gov Identifier: NCT02563106
• Recruitment Status: Completed
• First Posted: September 29, 2015
• Results First Posted: March 12, 2018
• Last Update Posted: November 27, 2018
• Sponsor: Synthetic Biologics Inc.
• Information provided by (Responsible Party): Synthetic Biologics Inc.

Tracking Information

• First Submitted Date: September 28, 2015
• First Posted Date: September 29, 2015
• Results First Submitted Date: February 12, 2018
• Results First Posted Date: March 12, 2018
• Last Update Posted Date: November 27, 2018
• Study Start Date: October 2015
• Actual Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 24, 2018)

Percentage of Patients With Clostridium Difficile Infection at 4- Weeks of Follow-up. [ Time Frame: Day 1 to the 4 week Follow-up Visit. ]

Percentage of subjects with CDI, based on the protocol definition of CDI (defined as 3 or more unformed stools per 24 hour period and a stool sample being positive for C. difficile toxin A and/or B [or their respective genes, tcdA and/or tcdB], based on the clinical site local laboratory results) from Day 1 to the 4-week Follow-up Visit in the SYN-004 treatment group compared to the placebo group, imputing early termination without CDI as not being treatment failures.

• Original Primary Outcome Measures (submitted: September 28, 2015): Percentage of patients with CDAD [ Time Frame: 4 weeks ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of SYN-004 for the Prevention of C.Diff in Patients With a LRTI
• 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
• Brief 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).
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Prevention

Condition

• Clostridium Difficile
• Clostridium Infections

Intervention

• Drug: SYN-004
• Drug: Placebo

Study Arms

• Experimental: SYN-004
  SYN-004 150 mg
  Intervention: Drug: SYN-004
• Placebo Comparator: Placebo
  Matching placebo
  Intervention: Drug: Placebo

• Publications *: Kokai-Kun JF, Roberts T, Coughlin O, Le C, Whalen H, Stevenson R, Wacher VJ, Sliman J. Use of ribaxamase (SYN-004), a β-lactamase, to prevent Clostridium difficile infection in β-lactam-treated patients: a double-blind, phase 2b, randomised placebo-controlled trial. Lancet Infect Dis. 2019 May;19(5):487-496. doi: 10.1016/S1473-3099(18)30731-X. Epub 2019 Mar 15.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 10, 2016): 413
• Original Estimated Enrollment (submitted: September 28, 2015): 372
• Actual Study Completion Date: November 2016
• Actual Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Bulgaria, Canada, Hungary, Poland, Romania, Serbia, United States

Administrative Information

• NCT Number: NCT02563106
• Other Study ID Numbers: SB-2-004-005
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Synthetic Biologics Inc.
• Study Sponsor: Synthetic Biologics Inc.
• Collaborators: Not Provided

Investigators

• Study Director: Michael Kaleko, MD; Synthetic Biologics

• PRS Account: Synthetic Biologics Inc.
• Verification Date: October 2018