Clinical trial NCT04003818: Efficacy and Safety of Teicoplanin in CDAD
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Clostridium Difficile Infection-associated Diarrhea and Colitis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2019-07-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: Clinical cure rate
timeFrame: 2 days after 7-14 days treatment
measure: Recurrence rate
timeFrame: Up to 10 weeks
measure: Time to resolution of diarrhea
timeFrame: Up to 10 weeks
Secondary outcomes:
measure: Incidence of nephrotoxicity
timeFrame: Until 10 weeks
measure: Incidence of hepatotoxicit
timeFrame: Up to 10 weeks
measure: Incidence of thrombocytopenia
timeFrame: Up to 10 weeks
measure: Incidence of hearing and balance/vestibular disorders
timeFrame: Up to 10 weeks
measure: Additional renal endpoints: renal failure, dialysis and renal replacement therapy
timeFrame: Until 10 weeks
measure: Any untoward adverse events/reactions
timeFrame: Up to 10 weeks
Other outcomes:
Locations:
city: China
country: China
facility: investigational site CHINA
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: