A Phase 4 interventional study of TEICOPLANIN in Clostridium Difficile Infection-associated Diarrhea and Colitis, sponsored by Sanofi. Terminated at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-23.
Sponsored by Sanofi · Phase 4, Interventional, and Treatment
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
1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.
This study's enrollment of 50 is below the median of 60 across 771 interventional studies indexed under Colitis.
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Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.
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Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
teicoplanin, administered orally 100-200 mg, twice a day
Drug: TEICOPLANIN
Pharmaceutical form:solution for oral administration Route of administration: oral
Clinical cure rate
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)
Time frame: 2 days after 7-14 days treatment
Recurrence rate
Recurrence is defined as reappearance of diarrhea during the 8-week follow-up period.
Time frame: Up to 10 weeks
Time to resolution of diarrhea
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.
Time frame: Up to 10 weeks
Incidence of nephrotoxicity
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.
Time frame: Until 10 weeks
Incidence of hepatotoxicit
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".
Time frame: Up to 10 weeks
Incidence of thrombocytopenia
Thrombocytopenia is defined as: platelets \< 100 000/mm3 or \< 100 Giga/L
Time frame: Up to 10 weeks
Incidence of hearing and balance/vestibular disorders
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".
Time frame: Up to 10 weeks
Additional renal endpoints: renal failure, dialysis and renal replacement therapy
Time frame: Until 10 weeks
Any untoward adverse events/reactions
Time frame: Up to 10 weeks
Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
This study is terminated, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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