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

Clostridium Difficile Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02563106
• Other study ID #: SB-2-004-005
• Status: Completed
• Phase: Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Clostridium Difficile
• Clostridium Infections
• Infection
• Respiratory Tract Infections

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.