Bezlotoxumab or fecal transplant for recurrent C. difficile infections

Phase 1

Active, not recruiting

Conditions: recurrent C. difficile infection
MedDRA version: 20.0Level: PTClassification code 10009657Term: Clostridium difficile colitisSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 20.0Level: LLTClassification code 10012748Term: Diarrhoea, Clostridium difficileSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 20.0Level: LLTClassification code 10012734Term: Diarrhea, Clostridium difficileSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Registration Number: EUCTR2021-004924-14-NL

Lead Sponsor: eiden University Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 66

Inclusion Criteria

- 18-90 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
- 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 66
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 66

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 antibiotics (other than for treatment of CDI) during the study period or directly after the intervention
- 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.