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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Synthetic Biologics Inc.
ClinicalTrials.gov Identifier:
NCT02563106
First received: September 28, 2015
Last updated: November 10, 2016
Last verified: November 2016
  Purpose
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 Intervention Phase
Clostridium Difficile
Clostridium Infections
Drug: SYN-004
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Further study details as provided by Synthetic Biologics Inc.:

Primary Outcome Measures:
  • Percentage of patients with CDAD [ Time Frame: 4 weeks ]

Enrollment: 413
Study Start Date: October 2015
Study Completion Date: November 2016
Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SYN-004
SYN-004 150 mg
Drug: SYN-004
Placebo Comparator: Placebo
Matching placebo
Drug: Placebo

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).
  Eligibility

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02563106

Locations
United States, Arkansas
Little Rock, Arkansas, United States, 72205
United States, Florida
DeLand, Florida, United States, 32720
United States, Georgia
Decatur, Georgia, United States, 30030
United States, Louisiana
Natchitoches, Louisiana, United States, 71457
United States, Maryland
Annapolis, Maryland, United States, 21401
Sponsors and Collaborators
Synthetic Biologics Inc.
Investigators
Study Director: Klaus Gottlieb, M.D. Synthetic Biologics
  More Information

Responsible Party: Synthetic Biologics Inc.
ClinicalTrials.gov Identifier: NCT02563106     History of Changes
Other Study ID Numbers: SB-2-004-005
Study First Received: September 28, 2015
Last Updated: November 10, 2016

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

ClinicalTrials.gov processed this record on March 22, 2017