Clostridium Difficile Infection-associated Diarrhea and Colitis
Conditions
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
Interventions
DRUGTEICOPLANIN
Pharmaceutical form:solution for oral administration Route of administration: oral
Sponsors
Sanofi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Any untoward adverse events/reactions | Up to 10 weeks | — |
| Additional renal endpoints: renal failure, dialysis and renal replacement therapy | Until 10 weeks | — |
| 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 |
Countries
China
Outcome results
None listed