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Safety and Efficacy of DAV132 in Patients at High-Risk for Clostridium Difficile Infection (CDI)

NCT03710694 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2019-08-30

No results posted yet for this study

Summary

The purpose of this study is to determine the safe use and evaluate the efficacy/performance of DAV132 in hospitalized patients at high risk for Clostridium difficile infection (CDI) and who receive fluoroquinolones (FQs) for the treatment of acute infections or for prophylaxis of febrile neutropenia.

Conditions

  • Clostridium Difficile Infection

Interventions

DEVICE

DAV132

DAV132: * Dosage: 15 g/day activated charcoal (22.5 g/day DAV132) * Route: Oral * Duration: duration of fluoroquinolone treatment + 2 days DAV132 is regulated as a medical device in Europe and as a drug in the United States of America.

Sponsors & Collaborators

Principal Investigators

  • Maria J.G.T Vehreschild, MD · Universitaetsklinikum Frankfurt

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-31
Primary Completion
2019-08-09
Completion
2019-08-09

Countries

  • Bulgaria
  • Germany
  • Romania
  • Serbia

Study Locations

More Related Trials

Entities

Companies

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 NCT03710694 on ClinicalTrials.gov