ew treatment strategy for patients with multiple recurrent Clostridioides difficile infection with bezlotoxumab as first optio

Phase 4

Withdrawn

Conditions: C. difficile associated diarhea
C. difficile colitis
C. difficile infection
10017966

Registration Number: NL-OMON52061

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 66

Inclusion Criteria

- minimum age is 18 years old
- diarrhea (3 or more unformed stools per 24h for two consecutive days; or ><= 8
unformed stools per 48h)
- positive PCR test for toxin A/B genes and/or positive toxin EIA for current
and previous episodes (low PCR cycle threshold value when only PCR performed)
- a minimum of two prior CDI episodes, at least one of these treated with
vancomycin or fidaxomicin
- previous episode is maximum of 3 months prior to the current episode
- the current episode responds well to Standard of Care treatment (vancomycin
or fidaxomicin orally).
- Assessment of the severity of the disease will be performed according to the
ESCMID recommendations.
- Both mild and severe CDI will be included

Exclusion Criteria

- Severe complicated CDI, i.e presence of: hypotension, septic shock, elevated
serum lactate, ileus, toxic megacolon, bowel perforation, or any fulminant
course of disease.
- ICU admission for underlying disease
- pregnancy or current desire for pregnancy
- breastfeeding
- prolonged use of therapeuric antibiotics (other than for treatment of CDI)
during oral standard of care CDI treatment or foreseeable antibiotic use
directly after the intervention. Aside from this, there are no specific
restrictions on concomitant medication of any kind.
- previous use of bezlotoxumab or fecal microbiota transplantation
- a history of underlying congestive heart failure (potential safety signal
phase-III trail bezlotoxumab).
- Diagnosis of inflammatory bowel disease in medical history.
- Any other condition which in the opinion of the investigator would make the
patient unsuitable for enrollment or could interfere with the patient
participating in and completing the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Global cure of the treatment strategy. Global cure is defined as cure without<br /><br>relapse of CDI within 12 weeks after completion of the treatment strategy in<br /><br>the study arm, i.e. after completion of secondary treatment in case of failure<br /><br>on initial treatment. </p><br>

Secondary Outcome Measures