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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Synthetic Biologics Inc.

ClinicalTrials.gov Identifier:

NCT02563106

First received: September 28, 2015

Last updated: November 10, 2016

Last verified: November 2016

History of Changes

Purpose

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).

Condition	Intervention	Phase
Clostridium Difficile Clostridium Infections	Drug: SYN-004 Drug: Placebo	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Investigator) Primary Purpose: Prevention
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

Further study details as provided by Synthetic Biologics Inc.:

Primary Outcome Measures:

Percentage of patients with CDAD [ Time Frame: 4 weeks ]


Enrollment:	413
Study Start Date:	October 2015
Study Completion Date:	November 2016
Primary Completion Date:	November 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: SYN-004 SYN-004 150 mg	Drug: SYN-004
Placebo Comparator: Placebo Matching placebo	Drug: Placebo

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


Ages Eligible for Study:	50 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02563106

Locations


United States, Arkansas

Little Rock, Arkansas, United States, 72205
United States, Florida

DeLand, Florida, United States, 32720
United States, Georgia

Decatur, Georgia, United States, 30030
United States, Louisiana

Natchitoches, Louisiana, United States, 71457
United States, Maryland

Annapolis, Maryland, United States, 21401

Sponsors and Collaborators

Synthetic Biologics Inc.

Investigators


Study Director:	Klaus Gottlieb, M.D.	Synthetic Biologics

More Information


Responsible Party:	Synthetic Biologics Inc.
ClinicalTrials.gov Identifier:	NCT02563106 History of Changes
Other Study ID Numbers:	SB-2-004-005
Study First Received:	September 28, 2015
Last Updated:	November 10, 2016

Additional relevant MeSH terms:


Infection Respiratory Tract Infections Clostridium Infections	Respiratory Tract Diseases Gram-Positive Bacterial Infections Bacterial Infections

ClinicalTrials.gov processed this record on June 23, 2017

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