NCT03710694

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

A European Multicenter, Randomized, Parallel-group Study to Evaluate the Safety and Efficacy/Performance of DAV132 in Hospitalized Patients at High Risk for Clostridium Difficile Infection and Who Receive Fluoroquinolones for the Treatment of Acute Infections

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 260 (actual)
• Sponsor: Da Volterra · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Da Volterra develops DAV132, a novel therapeutic option preserving the intestinal microbiota, to prevent potentially life-threatening conditions such as CDI or emergence of antibiotic-resistant bacteria. Prevention of CDI remains critical unmet need, especially for patients at high risk of developing such infection.

Conditions

• Clostridium Difficile Infection

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-10-31
• Primary completion: 2019-08-09
• Completion: 2019-08-09
• First posted: 2018-10-18
• Last updated: 2019-08-30

Locations

29 sites across 4 countries: Bulgaria, Germany, Romania, Serbia