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

Primary Purpose

Clostridium Difficile, Clostridium Infections

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SYN-004
Placebo
Sponsored by
Theriva Biologics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Clostridium Difficile

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Synthetic Biologics Investigational Site
  • Synthetic Biologics Investigational Site
  • Synthetic Biologics Investigational Site
  • Synthetic Biologics Investigational Site
  • Synthetic Biologics Investigational Site
  • Synthetic Biologics Investigational SIte
  • Synthetic Biologics Investigational Site
  • Synthetic Biologics Investigational Site
  • Synthetic Biologics Investigational Site
  • Synthetic Biologics Investigational Site
  • Synthetic Biologics Investigational Site
  • Synthetic Biologics Investigational Site
  • Synthetic Biologics Investigational Site
  • Synthetic Biologics Investigational Site
  • Synthetic Biologics Investigational Site
  • Synthetic Biologics Investigational Site
  • Synthetic Biologics Investigational Site
  • Synthetic Biologics Investigational Site
  • Synthetic Biologics Investigational Site
  • Synthetic Biologics Investigational Site
  • Synthetic Biologics Investigational Site
  • Synthetic Biologics Investigational Site
  • Synthetic Biologics Investigational Site
  • Synthetic Biologics Investigational Site
  • Synthetic Biologics Investigational Site
  • Synthetic Biologics Investigational Site
  • Synthetic Biologics Investigational Site
  • SyntheticBiologics Investigational Site
  • Synthetic Biologics Investigational Site
  • Synthetic Biologics Investigational Site
  • Synthetic Biologics Investigational Site
  • Synthetic Biologics Investigational Site
  • Synthetic Biologics Investigational SIte
  • Synthetic Biologics Investigational Site
  • Synthetic Biologics Investigational Site
  • Synthetic Biologics Investigational Site
  • Synthetic Biologics Investigational Site
  • Synthetic Biologics Investigational Site
  • Synthetic Biologics Investigational Site
  • Synthetic Biologics Investigational Site
  • Synthetic Biologics Investigational Site
  • Synthetic Biologics Investigational Site
  • Synthetic Biologics Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SYN-004

Placebo

Arm Description

SYN-004 150 mg

Matching placebo

Outcomes

Primary Outcome Measures

Percentage of Patients With Clostridium Difficile Infection at 4- Weeks of Follow-up.
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.

Secondary Outcome Measures

Full Information

First Posted
September 28, 2015
Last Updated
October 31, 2018
Sponsor
Theriva Biologics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02563106
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Theriva Biologics, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridium Difficile, Clostridium Infections

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
413 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SYN-004
Arm Type
Experimental
Arm Description
SYN-004 150 mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo
Intervention Type
Drug
Intervention Name(s)
SYN-004
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Percentage of Patients With Clostridium Difficile Infection at 4- Weeks of Follow-up.
Description
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.
Time Frame
Day 1 to the 4 week Follow-up Visit.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Kaleko, MD
Organizational Affiliation
Synthetic Biologics
Official's Role
Study Director
Facility Information:
Facility Name
Synthetic Biologics Investigational Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Synthetic Biologics Investigational Site
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Synthetic Biologics Investigational Site
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Synthetic Biologics Investigational Site
City
Będzin
State/Province
Louisiana
ZIP/Postal Code
71457
Country
United States
Facility Name
Synthetic Biologics Investigational Site
City
Debrecen
State/Province
Louisiana
ZIP/Postal Code
71457
Country
United States
Facility Name
Synthetic Biologics Investigational SIte
City
Natchitoches
State/Province
Louisiana
ZIP/Postal Code
71457
Country
United States
Facility Name
Synthetic Biologics Investigational Site
City
Gabrovo
Country
Bulgaria
Facility Name
Synthetic Biologics Investigational Site
City
Kyustendil
Country
Bulgaria
Facility Name
Synthetic Biologics Investigational Site
City
Lovech
Country
Bulgaria
Facility Name
Synthetic Biologics Investigational Site
City
Multiple Locations
Country
Bulgaria
Facility Name
Synthetic Biologics Investigational Site
City
Ruse
Country
Bulgaria
Facility Name
Synthetic Biologics Investigational Site
City
Sevlievo
Country
Bulgaria
Facility Name
Synthetic Biologics Investigational Site
City
Sofia
Country
Bulgaria
Facility Name
Synthetic Biologics Investigational Site
City
Tărgovište
Country
Bulgaria
Facility Name
Synthetic Biologics Investigational Site
City
Sherbrooke
Country
Canada
Facility Name
Synthetic Biologics Investigational Site
City
Toronto
Country
Canada
Facility Name
Synthetic Biologics Investigational Site
City
Balassagyarmat
Country
Hungary
Facility Name
Synthetic Biologics Investigational Site
City
Budapest
Country
Hungary
Facility Name
Synthetic Biologics Investigational Site
City
Veszprém
Country
Hungary
Facility Name
Synthetic Biologics Investigational Site
City
Białystok
Country
Poland
Facility Name
Synthetic Biologics Investigational Site
City
Bochnia
Country
Poland
Facility Name
Synthetic Biologics Investigational Site
City
Bydgoszcz
Country
Poland
Facility Name
Synthetic Biologics Investigational Site
City
Chodzież
Country
Poland
Facility Name
Synthetic Biologics Investigational Site
City
Oława
Country
Poland
Facility Name
Synthetic Biologics Investigational Site
City
Pomorskie
Country
Poland
Facility Name
Synthetic Biologics Investigational Site
City
Siedlce
Country
Poland
Facility Name
Synthetic Biologics Investigational Site
City
Tarnów
Country
Poland
Facility Name
SyntheticBiologics Investigational Site
City
Tychy
Country
Poland
Facility Name
Synthetic Biologics Investigational Site
City
Warszawice
Country
Poland
Facility Name
Synthetic Biologics Investigational Site
City
Łódź
Country
Poland
Facility Name
Synthetic Biologics Investigational Site
City
Arad
Country
Romania
Facility Name
Synthetic Biologics Investigational Site
City
Braşov
Country
Romania
Facility Name
Synthetic Biologics Investigational SIte
City
Bucharest
Country
Romania
Facility Name
Synthetic Biologics Investigational Site
City
Cluj-Napoca
Country
Romania
Facility Name
Synthetic Biologics Investigational Site
City
Oradea
Country
Romania
Facility Name
Synthetic Biologics Investigational Site
City
Otopeni
Country
Romania
Facility Name
Synthetic Biologics Investigational Site
City
Timişoara
Country
Romania
Facility Name
Synthetic Biologics Investigational Site
City
Belgrade
Country
Serbia
Facility Name
Synthetic Biologics Investigational Site
City
Gornji Matejevac
Country
Serbia
Facility Name
Synthetic Biologics Investigational Site
City
Kragujevac
Country
Serbia
Facility Name
Synthetic Biologics Investigational Site
City
Novi Sad
Country
Serbia
Facility Name
Synthetic Biologics Investigational Site
City
Užice
Country
Serbia
Facility Name
Synthetic Biologics Investigational Site
City
Čačak
Country
Serbia

12. IPD Sharing Statement

Citations:
PubMed Identifier
30885591
Citation
Kokai-Kun JF, Roberts T, Coughlin O, Le C, Whalen H, Stevenson R, Wacher VJ, Sliman J. Use of ribaxamase (SYN-004), a beta-lactamase, to prevent Clostridium difficile infection in beta-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.
Results Reference
derived

Learn more about this trial

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

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