ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02563106
Recruitment Status : Completed
First Posted : September 29, 2015
Results First Posted : March 12, 2018
Last Update Posted : June 25, 2018
Sponsor:
Information provided by (Responsible Party):
Synthetic Biologics Inc.

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).

Condition or disease Intervention/treatment Phase
Clostridium Difficile Clostridium Infections Drug: SYN-004 Drug: Placebo Phase 2

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  (Clinical Trial)
Actual Enrollment : 413 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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
Study Start Date : October 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Arm Intervention/treatment
Experimental: SYN-004
SYN-004 150 mg
Drug: SYN-004
Placebo Comparator: Placebo
Matching placebo
Drug: Placebo



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02563106


  Show 43 Study Locations
Sponsors and Collaborators
Synthetic Biologics Inc.
Investigators
Study Director: Joseph Sliman, MD Synthetic Biologics

Responsible Party: Synthetic Biologics Inc.
ClinicalTrials.gov Identifier: NCT02563106     History of Changes
Other Study ID Numbers: SB-2-004-005
First Posted: September 29, 2015    Key Record Dates
Results First Posted: March 12, 2018
Last Update Posted: June 25, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
Infection
Respiratory Tract Infections
Clostridium Infections
Respiratory Tract Diseases
Gram-Positive Bacterial Infections
Bacterial Infections