Clostridium Difficile Infection-associated Diarrhea and Colitis Clinical Trial
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
| Verified date | April 2022 |
| Source | Sanofi |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Terminated |
| Enrollment | 50 |
| Est. completion date | March 10, 2021 |
| Est. primary completion date | January 21, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion criteria : - Signed Informed Consent. - Male or female no less than 18 years of age. - Inpatient with a diagnosis of mild-moderate or severe CDAD (first occurrence or first recurrence within 3 months) with: Diarrhea: a change in bowel habits with > 3 liquid or unformed bowel movements (UBM) within 24 hours prior to enrollment, AND Positive C. difficile toxin test on a stool sample produced within 72 hours prior to enrollment. Exclusion criteria: - More than one previous episode of CDAD in the 3-month period prior to enrollment. - Evidence of life-threatening or fulminant CDAD. - Likelihood of death within 72 hours from any cause. - History of inflammatory colitides, chronic abdominal pain, or chronic diarrhea - Antimicrobial treatment active against CDAD administered for > 24 hours except for metronidazole treatment failures (MTF). - Known hypersensitivity or contraindication to teicoplanin. - Pregnant or nursing females. - Unable or unwilling to comply with all protocol requirements. - Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. |
| Country | Name | City | State |
|---|---|---|---|
| China | investigational site CHINA | China |
| Lead Sponsor | Collaborator |
|---|---|
| Sanofi |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) | 2 days after 7-14 days treatment | |
| Primary | Recurrence rate | Recurrence is defined as reappearance of diarrhea during the 8-week follow-up period. | Up to 10 weeks | |
| Primary | 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. | Up to 10 weeks | |
| Secondary | 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. | Until 10 weeks | |
| Secondary | 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". | Up to 10 weeks | |
| Secondary | Incidence of thrombocytopenia | Thrombocytopenia is defined as: platelets < 100 000/mm3 or < 100 Giga/L | Up to 10 weeks | |
| Secondary | 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". | Up to 10 weeks | |
| Secondary | Additional renal endpoints: renal failure, dialysis and renal replacement therapy | Until 10 weeks | ||
| Secondary | Any untoward adverse events/reactions | Up to 10 weeks |