Status:
UNKNOWN
Impact of Prescription Quality, Infection Control and Antimicrobial Stewardship on Gut Microbiota Domination by Healthcare-Associated Pathogens
Lead Sponsor:
University Hospital of Cologne
Collaborating Sponsors:
University Hospital of North Norway
Karolinska Institutet
Conditions:
Patients at High Risk of Antibacterial Treatment Upon Admission
Eligibility:
All Genders
18+ years
Brief Summary
Extended-spectrum beta-lactamase producing Enterobacteriaceae (EPE), vancomycin-resistant enterococci (VRE) and Clostridium difficile have become a major threat to hospitalised patients worldwide. We ...
Detailed Description
The prevalence of antimicrobial resistant pathogens has dramatically increased among hospitalised patients worldwide. While various management strategies have effectively reduced the burden caused by ...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Planned treatment or high likelihood of any systemic antibacterial treatment except trimethoprim/sulfamethoxazole within the next 10 days for a duration of ≥ 5 days
- Patients able to provide a stool sample before or within 4 hours of receiving first antibiotic dosage
- Written informed consent provided prior to inclusion
Exclusion
- Patients who have received courses of systemic antibacterials for 7 days or more within the past two months
- Patients having received any antibacterial compound other than trimethoprim/sulfamethoxazole within 14 days prior to study enrolment except first antibiotic dosage within 4 hours prior enrolment
- Patients with diarrhea at enrolment (≥3 unformed bowel movements within 24h)
- Patients with a stoma (jejunostomy, ileostomy, or colostomy) at time of inclusion
- Patients on enteral (tube fed or PEG) or parenteral nutrition
- 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
- Patients exclusively treated as outpatients without prior hospital admission
- Previous participation in this study
Key Trial Info
Start Date :
January 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 31 2022
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT03765528
Start Date
January 1 2019
End Date
July 31 2022
Last Update
August 3 2020
Active Locations (1)
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1
University Hospital of Cologne
Cologne, North Rhine-Westphalia, Germany, 50931