Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:47 AM
Ignite Modification Date:
2025-12-25 @ 4:47 AM
NCT ID:
NCT04003818
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04003818
Study Brief:
Protocol Section:
NCT04003818