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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02563106
Other study ID # SB-2-004-005
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date October 2015
Est. completion date November 2016

Study information

Verified date October 2018
Source Synthetic Biologics Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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).


Recruitment information / eligibility

Status Completed
Enrollment 413
Est. completion date November 2016
Est. primary completion date November 2016
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility 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 Design


Intervention

Drug:
SYN-004

Placebo


Locations

Country Name City State
Bulgaria Synthetic Biologics Investigational Site 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 Targovište
Canada Synthetic Biologics Investigational Site Sherbrooke
Canada Synthetic Biologics Investigational Site Toronto
Hungary Synthetic Biologics Investigational Site Balassagyarmat
Hungary Synthetic Biologics Investigational Site Budapest
Hungary Synthetic Biologics Investigational Site Veszprém
Poland Synthetic Biologics Investigational Site Bialystok
Poland Synthetic Biologics Investigational Site Bochnia
Poland Synthetic Biologics Investigational Site Bydgoszcz
Poland Synthetic Biologics Investigational Site Chodziez
Poland Synthetic Biologics Investigational Site Lódz
Poland Synthetic Biologics Investigational Site Olawa
Poland Synthetic Biologics Investigational Site Pomorskie
Poland Synthetic Biologics Investigational Site Siedlce
Poland Synthetic Biologics Investigational Site Tarnów
Poland SyntheticBiologics Investigational Site Tychy
Poland Synthetic Biologics Investigational Site Warszawice
Romania Synthetic Biologics Investigational Site Arad
Romania Synthetic Biologics Investigational Site Brasov
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 Timisoara
Serbia Synthetic Biologics Investigational Site Belgrade
Serbia Synthetic Biologics Investigational Site Cacak
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
United States Synthetic Biologics Investigational Site Bedzin Louisiana
United States Synthetic Biologics Investigational Site Debrecen Louisiana
United States Synthetic Biologics Investigational Site DeLand Florida
United States Synthetic Biologics Investigational Site Little Rock Arkansas
United States Synthetic Biologics Investigational SIte Natchitoches Louisiana
United States Synthetic Biologics Investigational Site Torrance California

Sponsors (1)

Lead Sponsor Collaborator
Synthetic Biologics Inc.

Countries where clinical trial is conducted

United States,  Bulgaria,  Canada,  Hungary,  Poland,  Romania,  Serbia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Day 1 to the 4 week Follow-up Visit.
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