Efficacy and Safety of Teicoplanin in CDAD
Efficacy and Safety of Teicoplanin in CDAD
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
Approximate 10 weeks
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.