AssessmeNT of the Incidence of Clostridium difficile Infections in hospitalized Patients on Antibiotic TrEatment

Completed

• Conditions: Clostridium difficile infection; diarrhea caused by the bacterium Clostridium difficile; 10017966; 10004018

• Registration Number: NL-OMON42976
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

1. Male or female hospitalized patient.
2. Aged ><= 50 years old.
3. Initiation of intravenous or oral treatment with intended duration *5 days (*1 day for clindamycin) with at least one of the following antibiotic classes, or treatment scheduled within the next 72 hours:
- Third or fourth generation cephalosporins
- Fluoroquinolones
- Penicillins +beta-lactamase inhibitors
- Clindamycin
- Carbapenems
4. Written informed consent provided prior to inclusion.

Exclusion Criteria

1. Ongoing antibiotic treatment with one of the above classes initiated >6 hours before inclusion into the study.
2. ICU admission at the time of inclusion or anticipated admission within 48h.
3. Suspected or diagnosed CDI, ongoing treatment for CDI, or diarrhoea at the time of inclusion.
4. Subject has been included into this study previously.
5. Patient treated with probiotics to prevent CDI.
6. Patient with any social or logistical condition which in the opinion of the investigator may interfere with the conduct of the study, such as incapacity to well understand, not willing to collaborate, or cannot easily be contacted after discharge.
7. Subject deprived of liberty by judicial or administrative decision.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Incidence of CDI within 28 days of initiation of antibiotic treatment.</p><br>