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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

413

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Oct 2015

Shorter than P25 for phase_2

Geographic Reach

7 countries

43 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.1 years study duration

First Submitted

Initial submission to the registry

September 28, 2015

Completed

1 day until next milestone

First Posted

Study publicly available on registry

September 29, 2015

Completed

2 days until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed

1.4 years until next milestone

Results Posted

Study results publicly available

March 12, 2018

Completed

Last Updated

November 27, 2018

Status Verified

October 1, 2018

Enrollment Period

1.1 years

First QC Date

September 28, 2015

Results QC Date

February 12, 2018

Last Update Submit

October 31, 2018

Conditions

Clostridium Difficile Clostridium Infections

Outcome Measures

Primary Outcomes (1)

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.

Study Arms (2)

SYN-004

EXPERIMENTAL

SYN-004 150 mg

Drug: SYN-004

Placebo

PLACEBO COMPARATOR

Matching placebo

Drug: Placebo

Interventions

SYN-004DRUG

SYN-004

PlaceboDRUG

Placebo

Eligibility Criteria

Age50 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.