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NCT03105479 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Actelion.

Terminated
Registry status
Phase 2
Development phase
1
Enrollment target

NCT03105479: Clinical Trial Phase 2 study, sponsored by Actelion.

NCT03105479 is a Phase 2 study that was terminated before completion, run by Actelion. The registered enrollment target is 1 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03105479, a Phase 2 study, was terminated before completion, sponsored by Actelion.

TERMINATED
Registry status
Phase 2
Development phase
1 participants
Enrollment target

Study 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.

Primary Outcome

This is the percentage of participants in part B reported as with a clinical cure. Clinical Cure is defined as: • \<3 unformed bowel movement (UBM) per day (or no water diarrhea if subjects \< 2 years of age), for at least 2 consecutive days between first dose of study treatment up to end of treatment (EOT) (inclusive) AND • Subject remains well up to EOT + 2 days (inclusive) based on investigator judgment AND • No need for additional antimicrobial treatment active against Clostridium difficile-

Interventions

  • DRUG Cadazolid
  • DRUG Vancomycin capsule
  • DRUG Vancomycin solution

Trial Details

FieldValue
Enrollment Target 1 participants
Start Date 2017-04-14
Est. Completion 2018-04-17
Phase Phase 2
Actelion

63 total trials

Why NCT03105479 stopped before completion

NCT03105479 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 3 interventions - of which Cadazolid is the first listed.

NCT03105479 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03105479 about?

NCT03105479 is a clinical study titled "Comparison of Cadazolid Versus Vancomycin in Children With Clostridium Difficile-associated Diarrhea (CDAD)". 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 ca...

What is the current status of trial NCT03105479?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2017-04-14. Estimated completion is 2018-04-17.

What interventions are being tested in trial NCT03105479?

The interventions under investigation include: Cadazolid (DRUG), Vancomycin capsule (DRUG), Vancomycin solution (DRUG).

Who is sponsoring clinical trial NCT03105479?

This trial is sponsored by Actelion, which has 63 total clinical trials registered on ClinicalTrials.gov.

Learn More About Clinical Trials

How this trial's enrollment target compares

Where NCT03105479's enrollment target sits among peer trials

1 2001st of 2000 the lowest of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03105479, the US trial registry maintained by the National Library of Medicine. NCT03105479 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.