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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Pharmaceutical form:solution for oral administration Route of administration: oral
investigational site CHINA
China, China
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
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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