Efficacy and Safety of Teicoplanin in CDAD

Prospective, Interventional, Phase IV Study, Evaluating the Efficacy and Safety of Teicoplanin (100-200 mg, Administered Orally Twice a Day) in Patients With Clostridium Difficile Infection-associated Diarrhea and Colitis

NCT04003818•Sanofi

View on ClinicalTrials.gov

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

Detailed Description

Approximate 10 weeks

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

investigational site CHINA

China, China

Key Dates

Start Date

May 15, 2020

Primary Completion Date

January 21, 2021

Completion Date

March 10, 2021

Last Updated

September 23, 2025

Enrollment

ACTUAL participants

Conditions

Clostridium Difficile Infection-associated Diarrhea and Colitis

Interventions

TEICOPLANIN

DRUG