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

NCT02563106 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 413

Last updated 2018-11-27

Study results available
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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).

Conditions

  • Clostridium Difficile
  • Clostridium Infections

Interventions

DRUG

SYN-004

DRUG

Placebo

Sponsors & Collaborators

  • Theriva Biologics, Inc.

    lead INDUSTRY

Principal Investigators

  • Michael Kaleko, MD · Synthetic Biologics

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • United States
  • Bulgaria
  • Canada
  • Hungary
  • Poland
  • Romania
  • Serbia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02563106 on ClinicalTrials.gov