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).
Brief Title
A Study of SYN-004 for the Prevention of C.Diff in Patients With a 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).
Categories
Completion Date
Completion Date Type
Actual
Conditions
Clostridium Difficile
Clostridium Infections
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.
* 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.
Inclusion 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.
* 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.
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
50 Years
NCT Id
NCT02563106
Org Class
Industry
Org Full Name
Theriva Biologics, Inc.
Org Study Id
SB-2-004-005
Overall Status
Completed
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
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
Primary Outcomes
Outcome 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.
Outcome Measure
Percentage of Patients With Clostridium Difficile Infection at 4- Weeks of Follow-up.
Outcome Time Frame
Day 1 to the 4 week Follow-up Visit.
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
50
Investigators
Investigator Type
Principal Investigator
Investigator Name
Paul Riska
Investigator Email
priska@montefiore.org
Investigator Phone
718-020-6494
Categories Mesh Debug
COVID-19 --- INFECTIONS
Infectious Disease --- INFECTIONS
MeSH Terms
CLOSTRIDIUM INFECTIONS
GRAM-POSITIVE BACTERIAL INFECTIONS
BACTERIAL INFECTIONS
BACTERIAL INFECTIONS AND MYCOSES
INFECTIONS
SYN-004
COUNTERFEIT DRUGS
SUBSTANDARD DRUGS
PHARMACEUTICAL PREPARATIONS