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
Overview
- Phase
- Phase 4
- Intervention
- TEICOPLANIN
- Conditions
- Clostridium Difficile Infection-associated Diarrhea and Colitis
- Sponsor
- Sanofi
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Recurrence rate
- Status
- Terminated
- Last Updated
- 7 months ago
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Teicoplanin
teicoplanin, administered orally 100-200 mg, twice a day
Intervention: TEICOPLANIN
Outcomes
Primary Outcomes
Recurrence rate
Time Frame: Up to 10 weeks
Recurrence is defined as reappearance of diarrhea during the 8-week follow-up period.
Time to resolution of diarrhea
Time Frame: Up to 10 weeks
Resolution of diarrhea (ROD) (≤ 3 unformed bowel movement (UBM) per day for at least 2 consecutive days) on study treatment and maintained for 2 days after end of treatment.
Clinical cure rate
Time Frame: 2 days after 7-14 days treatment
Clinical cure is defined as: Resolution of diarrhea (ROD) (≤ 3 unformed bowel movement (UBM) per day for at least 2 consecutive days) on study treatment and maintained for 2 days after End of treatment (EOT), AND No additional antimicrobial treatment active against Clostridium difficile-associated diarrhea (CDAD) or fecal microbiota transplant (FMT) between first dose of study drug and 2 days after EOT (inclusive)
Secondary Outcomes
- Incidence of nephrotoxicity(Until 10 weeks)
- Incidence of hepatotoxicit(Up to 10 weeks)
- Incidence of thrombocytopenia(Up to 10 weeks)
- Incidence of hearing and balance/vestibular disorders(Up to 10 weeks)
- Additional renal endpoints: renal failure, dialysis and renal replacement therapy(Until 10 weeks)
- Any untoward adverse events/reactions(Up to 10 weeks)