At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 413 enrolled
Drug / intervention
SYN-004 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating SYN-004 and Placebo for Clostridium Difficile and Clostridium Infections. Completed, enrolled 413 participants across 43 sites in 7 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsClostridium Difficile, Clostridium Infections
CountriesBulgaria, Canada, Hungary, Poland, Romania, Serbia, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 2015
Enrollment StartOct 2015
Primary CompletionNov 2016
TodayJul 2026
First PostedSep 29, 2015
Enrollment StartOct 1, 2015
Primary CompletionNov 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 10.8 years ago
Interventions
SYN-004drug
Placebodrug