Efficacy and Safety of Teicoplanin in CDAD

Sanofi

Status and phase: Terminated; Phase 4

Conditions: Clostridium Difficile Infection-associated Diarrhea and Colitis

Treatments: Drug: TEICOPLANIN

Study type: Interventional

Funder types: Industry

Identifiers

NCT04003818

U1111-1230-0601 (Other Identifier)

LPS16229

Details and patient eligibility

About

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

Full description

Approximate 10 weeks

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Teicoplanin

Experimental group

Description:

teicoplanin, administered orally 100-200 mg, twice a day

Treatment:

Drug: TEICOPLANIN