Efficacy and Safety of Teicoplanin in CDAD
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|ClinicalTrials.gov Identifier: NCT04003818|
Recruitment Status : Recruiting
First Posted : July 1, 2019
Last Update Posted : August 14, 2020
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
Evaluate the safety of teicoplanin in patients with Clostridium difficile infection-associated diarrhea and colitis
|Condition or disease||Intervention/treatment||Phase|
|Clostridium Difficile Infection-associated Diarrhea and Colitis||Drug: TEICOPLANIN||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||May 15, 2020|
|Estimated Primary Completion Date :||October 2022|
|Estimated Study Completion Date :||October 2022|
teicoplanin, administered orally 100-200 mg, twice a day
Pharmaceutical form:solution for oral administration Route of administration: oral
- 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)
- 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.
- Incidence of nephrotoxicity [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Up to 10 weeks ]Thrombocytopenia is defined as: platelets < 100 000/mm3 or < 100 Giga/L
- Incidence of hearing and balance/vestibular disorders [ Time Frame: 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 [ Time Frame: Until 10 weeks ]
- Any untoward adverse events/reactions [ Time Frame: Up to 10 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04003818
|Contact: Trial Transparency email recommended (Toll free number for US & Canada)||800-633-1610 ext option 6||Contact-US@sanofi.com|
|investigational site CHINA||Recruiting|
|Study Director:||Clinical Sciences & Operations||Sanofi|