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Comparison of Cadazolid Versus Vancomycin in Children With Clostridium Difficile-associated Diarrhea (CDAD)

NCT03105479 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2025-07-08

Study results available
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Summary

Cadazolid has demonstrated activity against a bacteria named Clostridium difficile in animal studies. The results of a first study conducted in adult patients have suggested efficacy of the new antibiotic, cadazolid, in the treatment of diarrhea caused by this bacteria. This is the first study of cadazolid in children. The overall purpose of this study is to provide reassurance on the safety and efficacy of cadazolid in children suffering from infection due to Clostridium difficile.

Conditions

  • Clostridium Difficile Infection

Interventions

DRUG

Cadazolid

Granules for oral suspension to be administered twice daily

DRUG

Vancomycin capsule

Capsule containing 125 mg of vancomycin to be administered orally 4 times a day

DRUG

Vancomycin solution

Vancomycin powder to be administered as oral solution at a dose of 40 mg/kg/day, 3 to 4 times a day

Sponsors & Collaborators

  • Actelion

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-14
Primary Completion
2018-04-17
Completion
2018-04-17
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • Czechia
  • Hungary
  • Italy
  • Poland
  • Romania
  • Spain

Study Locations

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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 NCT03105479 on ClinicalTrials.gov