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

October 31, 2018 updated by: Synthetic Biologics Inc.

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

413

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • 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
      • Ruse, Bulgaria
        • Synthetic Biologics Investigational Site
      • Sevlievo, Bulgaria
        • Synthetic Biologics Investigational Site
      • Sofia, Bulgaria
        • Synthetic Biologics Investigational Site
      • Tărgovište, Bulgaria
        • Synthetic Biologics Investigational Site
  • Canada
      • Sherbrooke, Canada
        • Synthetic Biologics Investigational Site
      • Toronto, Canada
        • Synthetic Biologics Investigational Site
  • Hungary
      • Balassagyarmat, Hungary
        • Synthetic Biologics Investigational Site
      • Budapest, Hungary
        • Synthetic Biologics Investigational Site
      • Veszprém, Hungary
        • Synthetic Biologics Investigational Site
  • Poland
      • Białystok, Poland
        • Synthetic Biologics Investigational Site
      • Bochnia, Poland
        • Synthetic Biologics Investigational Site
      • Bydgoszcz, Poland
        • Synthetic Biologics Investigational Site
      • Chodzież, Poland
        • Synthetic Biologics Investigational Site
      • Oława, Poland
        • Synthetic Biologics Investigational Site
      • Pomorskie, Poland
        • Synthetic Biologics Investigational Site
      • Siedlce, Poland
        • Synthetic Biologics Investigational Site
      • Tarnów, Poland
        • Synthetic Biologics Investigational Site
      • Tychy, Poland
        • SyntheticBiologics Investigational Site
      • Warszawice, Poland
        • Synthetic Biologics Investigational Site
      • Łódź, Poland
        • Synthetic Biologics Investigational Site
  • Romania
      • Arad, Romania
        • Synthetic Biologics Investigational Site
      • Braşov, Romania
        • Synthetic Biologics Investigational Site
      • Bucharest, Romania
        • Synthetic Biologics Investigational Site
      • Cluj-Napoca, Romania
        • Synthetic Biologics Investigational Site
      • Oradea, Romania
        • Synthetic Biologics Investigational Site
      • Otopeni, Romania
        • Synthetic Biologics Investigational Site
      • Timişoara, Romania
        • Synthetic Biologics Investigational Site
  • Serbia
      • Belgrade, Serbia
        • Synthetic Biologics Investigational Site
      • Gornji Matejevac, Serbia
        • Synthetic Biologics Investigational Site
      • Kragujevac, Serbia
        • Synthetic Biologics Investigational Site
      • Novi Sad, Serbia
        • Synthetic Biologics Investigational Site
      • Užice, Serbia
        • Synthetic Biologics Investigational Site
      • Čačak, Serbia
        • Synthetic Biologics Investigational Site
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Synthetic Biologics Investigational Site
    • California
      • Torrance, California, United States, 90502
        • Synthetic Biologics Investigational Site
    • Florida
      • DeLand, Florida, United States, 32720
        • Synthetic Biologics Investigational Site
    • Louisiana
      • Będzin, Louisiana, United States, 71457
        • Synthetic Biologics Investigational Site
      • Debrecen, Louisiana, United States, 71457
        • Synthetic Biologics Investigational Site
      • Natchitoches, Louisiana, United States, 71457
        • Synthetic Biologics Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Matching placebo
Drug: Placebo
Experimental: SYN-004
SYN-004 150 mg
Drug: SYN-004

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1 to the 4 week Follow-up Visit.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Synthetic Biologics Inc.

Investigators

  • Study Director: Michael Kaleko, MD, Synthetic Biologics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

September 28, 2015

First Submitted That Met QC Criteria

September 28, 2015

First Posted (Estimate)

September 29, 2015

Study Record Updates

Last Update Posted (Actual)

November 27, 2018

Last Update Submitted That Met QC Criteria

October 31, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SB-2-004-005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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