Efficacy and Safety of Teicoplanin in CDAD

  • STATUS
    Recruiting
  • participants needed
    50
  • sponsor
    Sanofi
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Updated on 4 December 2020
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Summary

Primary Objective:

Explore the efficacy of teicoplanin (100-200 mg administered orally twice a day for 7 to 14 days) in patients with Clostridium difficile infection-associated diarrhea and colitis

Secondary Objective:

Evaluate the safety of teicoplanin in patients with Clostridium difficile infection-associated diarrhea and colitis

Description

Approximate 10 weeks

Details
Condition Clostridium Difficile Infection-associated Diarrhea and Colitis
Age 18years - 100years
Treatment TEICOPLANIN
Clinical Study IdentifierNCT04003818
SponsorSanofi
Last Modified on4 December 2020

Eligibility

 Yes No Not Sure

Inclusion Criteria

Signed Informed Consent
Male or female no less than 18 years of age
Inpatient with a diagnosis of mild-moderate or severe CDAD (first occurrence or first recurrence within 3 months) with: Diarrhea: a change in bowel habits with > 3 liquid or unformed bowel movements (UBM) within 24 hours prior to enrollment, AND Positive C. difficile toxin test on a stool sample produced within 72 hours prior to enrollment

Exclusion Criteria

More than one previous episode of CDAD in the 3-month period prior to enrollment
Evidence of life-threatening or fulminant CDAD
Likelihood of death within 72 hours from any cause
History of inflammatory colitides, chronic abdominal pain, or chronic diarrhea
Antimicrobial treatment active against CDAD administered for > 24 hours except for metronidazole treatment failures (MTF)
Known hypersensitivity or contraindication to teicoplanin
Pregnant or nursing females
Unable or unwilling to comply with all protocol requirements
Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
The above information is not intended to contain all considerations relevant
to a patient's potential participation in a clinical trial
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