Impact of Prescription Quality, Infection Control and Antimicrobial Stewardship on Gut Microbiota… (NCT03765528) | Clinical Trial Compass
UnknownNot Applicable
Impact of Prescription Quality, Infection Control and Antimicrobial Stewardship on Gut Microbiota Domination by Healthcare-Associated Pathogens
Germany1,500 participantsStarted 2019-01-01
Plain-language 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 hypothesize that receiving inappropriate antibacterial treatment places patients at high risk of intestinal domination and subsequent infection by these bacteria. Further analyses will address cost-effectiveness of specific interventions, behavioural analyses of the decision process leading to inappropriate antibacterial treatment, and the rate of undetected colonization with EPE/VRE/C. difficile on admission.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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 criteria
✕. 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
What they're measuring
1
Impact of inappropriate antibacterial prescription on intestinal microbiota domination by healthcare associated pathogens
✕. 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