Clinical trial NCT02563106: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Clostridium Difficile
Clostridium Infections
Lead sponsor: Theriva Biologics, Inc.
Sponsor class: INDUSTRY
First posted: 2015-09-29
Enrollment: 413
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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.

Primary outcomes:
measure: Percentage of Patients With Clostridium Difficile Infection at 4- Weeks of Follow-up.
timeFrame: Day 1 to the 4 week Follow-up Visit.
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Synthetic Biologics Investigational Site
state: Arkansas
city: Torrance
country: United States
facility: Synthetic Biologics Investigational Site
state: California
city: DeLand
country: United States
facility: Synthetic Biologics Investigational Site
state: Florida
city: Będzin
country: United States
facility: Synthetic Biologics Investigational Site
state: Louisiana
city: Debrecen
country: United States
facility: Synthetic Biologics Investigational Site
state: Louisiana
city: Natchitoches
country: United States
facility: Synthetic Biologics Investigational SIte
state: Louisiana
city: Gabrovo
country: Bulgaria
facility: Synthetic Biologics Investigational Site
city: Kyustendil
country: Bulgaria
facility: Synthetic Biologics Investigational Site
city: Lovech
country: Bulgaria
facility: Synthetic Biologics Investigational Site
city: Multiple Locations
country: Bulgaria
facility: Synthetic Biologics Investigational Site
city: Ruse
country: Bulgaria
facility: Synthetic Biologics Investigational Site
city: Sevlievo
country: Bulgaria
facility: Synthetic Biologics Investigational Site
city: Sofia
country: Bulgaria
facility: Synthetic Biologics Investigational Site
city: Tărgovište
country: Bulgaria
facility: Synthetic Biologics Investigational Site
city: Sherbrooke
country: Canada
facility: Synthetic Biologics Investigational Site
city: Toronto
country: Canada
facility: Synthetic Biologics Investigational Site
city: Balassagyarmat
country: Hungary
facility: Synthetic Biologics Investigational Site
city: Budapest
country: Hungary
facility: Synthetic Biologics Investigational Site
city: Veszprém
country: Hungary
facility: Synthetic Biologics Investigational Site
city: Białystok
country: Poland
facility: Synthetic Biologics Investigational Site
city: Bochnia
country: Poland
facility: Synthetic Biologics Investigational Site
city: Bydgoszcz
country: Poland
facility: Synthetic Biologics Investigational Site
city: Chodzież
country: Poland
facility: Synthetic Biologics Investigational Site
city: Oława
country: Poland
facility: Synthetic Biologics Investigational Site
city: Pomorskie
country: Poland
facility: Synthetic Biologics Investigational Site
city: Siedlce
country: Poland
facility: Synthetic Biologics Investigational Site
city: Tarnów
country: Poland
facility: Synthetic Biologics Investigational Site
city: Tychy
country: Poland
facility: SyntheticBiologics Investigational Site
city: Warszawice
country: Poland
facility: Synthetic Biologics Investigational Site
city: Łódź
country: Poland
facility: Synthetic Biologics Investigational Site
city: Arad
country: Romania
facility: Synthetic Biologics Investigational Site
city: Braşov
country: Romania
facility: Synthetic Biologics Investigational Site
city: Bucharest
country: Romania
facility: Synthetic Biologics Investigational SIte
city: Cluj-Napoca
country: Romania
facility: Synthetic Biologics Investigational Site
city: Oradea
country: Romania
facility: Synthetic Biologics Investigational Site
city: Otopeni
country: Romania
facility: Synthetic Biologics Investigational Site
city: Timişoara
country: Romania
facility: Synthetic Biologics Investigational Site
city: Belgrade
country: Serbia
facility: Synthetic Biologics Investigational Site
city: Gornji Matejevac
country: Serbia
facility: Synthetic Biologics Investigational Site
city: Kragujevac
country: Serbia
facility: Synthetic Biologics Investigational Site
city: Novi Sad
country: Serbia
facility: Synthetic Biologics Investigational Site
city: Užice
country: Serbia
facility: Synthetic Biologics Investigational Site
city: Čačak
country: Serbia
facility: Synthetic Biologics Investigational Site
Study officials:
affiliation: Synthetic Biologics
name: Michael Kaleko, MD
role: STUDY_DIRECTOR
References:
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.