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OpenTrials
Completed

NCT Number: NCT01222702

Efficacy, Safety and Tolerability of Cadazolid in Subjects With Clostridium Difficile Associated Diarrhea (CDAD)

Cadazolid is a new antibiotic developed for the treatment of Clostridiun difficile associated diarrhea (CDAD), also known as Clostridium Difficile Infection (CDI). The purpose of the study was to evaluate the efficacy and safety of different doses of cadazolid in order to find the dose of cadazolid to be used for further clinical development of the compound in subjects with CDAD.

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Key information

Conditions

Clostridium Difficile Infection Bacterial Infections Bacterial Infections and Mycoses Clostridium Infections Gram-Positive Bacterial Infections Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clinical Investigative Site 6605, Victoria, British Columbia, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Male or female
  • At least 18 years of age
  • With a diagnosis of Clostridium Difficile-associated diarrhea (CDAD): first occurrence or first recurrence.

Key Exclusion Criteria:

  • Concurrent life threatening condition.
  • Immuno-compromised subjects, concomittant immuno-suppresive treatment.
  • Concomitant antimicrobial treatment for CDAD.
  • Any circumstances or conditions, which, in the opinion of the investigator, would affect full participation of the subject in the study or compliance with the protocol

Treatment and study plan

Cadazolid

Drug

Cadazolid, provided as powder (250 mg, 500 mg or 1000 mg) to be reconstituted as a suspension prior to oral administration

Other names: ACT-179811

Vancomycin

Drug

Vancomycin, provided as capsules (125 mg) for oral administration

Other names: Vancomycin hydrochloride

Placebo-matching cadazolid

Drug

Placebo of cadazolid powder for oral suspension

Placebo-matching vancomycin

Drug

Placebo of vancomycin capsules

Primary outcomes

  1. Clinical cure rate at test-of-cure

    Time frame: Day 13 or 24-72 hours after end of treatment

    Percentages of subjects with clinical cure are calculated, with clinical cure being defined as resolution of diarrhea with no further Clostridium Difficile-associated diarrhea (CDAD) treatment required at test-of-cure (TOC) visit.

    Resolution of diarrhea was defined as the occurrence of ≤ 2 semi-formed or formed stools during 24 h for at least 2 consecutive 24 h periods.

Secondary outcomes

  1. Recurrence rate

    Time frame: Between Day 13 and Day 41 (within 4 weeks after end of treatment)

    Percentages of subjects with recurrence are calculated, with recurrence being defined as the occurrence of diarrhea (> 3 liquid or unformed stools within 24 h associated with positive C. difficile toxin A/B assay) within 4 weeks after EOT in subjects clinically cured (at test-of-cure).

  2. Sustained cure rate

    Time frame: Between Day 13 and day 41 (within 4 weeks after end of treatment)

    Percentages of subjects with sustained cure are calculated, with sustained cure being defined as clinical cure without CDAD recurrence up to the end of study

  3. Time to resolution of diarrhea

    Time frame: From Day 1 up to Day 13 (or 24-72 hours after end of treatment)

    Time to resolution of diarrhea was defined as the time (h) from the first intake of study treatment to the time (occurrence) of the first stool meeting the criteria for resolution of diarrhea up to test-of-cure.

  4. Incidence of treatment-emergent adverse events

    Time frame: From Day 1 to Day 14

    Percentage of subjects with any adverse events in each group from first study treatment intake up to 3 days after last study drug intake

  5. Adverse events leading to premature discontinuation of study treatment

    Time frame: Up to Day 10

    Number of patients in each group who discontinued the study treatment due to an adverse event

Other outcomes

  1. Modified clinical cure rate

    Time frame: Day 13 or 24-72 hours after end of treatment

    Percentage of subjects with modified clinical cure (mCC) is reported, with mCC defined as the occurrence of ≤ 3 liquid or unformed stools and any number of semi-formed or formed stools per day for at least two consecutive days, and thereafter maintained up to TOC visit. In addition, no concomitant medication active against CDAD received from the start of study treatment up to TOC

Sponsors and collaborators

Lead sponsor

Actelion

Industry

Registry information

Official study title

A Multi-center, Double-blind, Randomized, Active Reference, Parallel Group Study to Evaluate the Efficacy, Safety and Tolerability of a 10-day Twice Daily Oral Administration of Three Doses of Cadazolid (ACT-179811) in Subjects With Clostridium Difficile Associated Diarrhea (CDAD)

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 18, 2010
Registry last updated
Jun 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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