Efficacy and Safety of Teicoplanin in CDAD

Phase 4

Terminated

• Conditions: Clostridium Difficile Infection-associated Diarrhea and Colitis
• Interventions: Drug: TEICOPLANIN

• Registration Number: NCT04003818
• Lead Sponsor: Sanofi

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

Study Timeline

• Study First Submitted: 2019-06-06
• Study First Submitted QC: 2019-06-28
• Study First Posted: 2019-07-01
• Study Start: 2020-05-15
• Primary Completion: 2021-01-21
• Study Completion: 2021-03-10
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Teicoplanin	TEICOPLANIN	teicoplanin, administered orally 100-200 mg, twice a day

Primary Outcome Measures

Name	Time	Method
Recurrence rate	Up to 10 weeks	Recurrence is defined as reappearance of diarrhea during the 8-week follow-up period.
Time to resolution of diarrhea	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	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 Outcome Measures

Name	Time	Method
Incidence of nephrotoxicity	Until 10 weeks	Nephrotoxicity is defined as: serum creatinine increase of more than 0.5 mg/dL if the baseline serum creatinine was ≤ 3 mg/dL or a rise of \> 1 mg/dL if the initial serum creatinine was \> 3 mg/dL; or 50% increase from baseline; or a drop in calculated creatinine clearance using Cockroft-Gault formula of ≥ 50% from baseline.
Incidence of hepatotoxicit	Up to 10 weeks	Hepatotoxicity is defined as: AST or ALT 3 times upper limit of normal or if AST or ALT baseline is abnormal, AST or ALT increase of ≥ 3 times the baseline and adverse events/ reactions using the MedDRA SMQ (Standardised MedDRA Query) "Hepatic Disorders".
Incidence of thrombocytopenia	Up to 10 weeks	Thrombocytopenia is defined as: platelets \< 100 000/mm3 or \< 100 Giga/L
Incidence of hearing and balance/vestibular disorders	Up to 10 weeks	Hearing and balance/vestibular disorders are defined as: identified via PT terms using MedDRA SMQ for "hearing and vestibular disorders" (narrow) and additionally the PT "balance disorder".
Additional renal endpoints: renal failure, dialysis and renal replacement therapy	Until 10 weeks
Any untoward adverse events/reactions	Up to 10 weeks

Trial Locations

Locations (1)

investigational site CHINA; 🇨🇳 China, China