Infection risk from carrying drug-resistant gut bacteria in hospitalized adults
Association Between Digestive MDRO Carriage and Infection Risk in Hospitalized Patients: A Single-Center Prospective Analysis
This project will test whether carrying multidrug-resistant bacteria in the gut increases the chance that adults admitted to hospital will get a healthcare-associated infection.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Emergency and Clinical Hospital "Dr. Agrippa Ionescu" Academic / other |
| Locations | 1 site (Bucharest, Bucharest) |
| Trial ID | NCT07134270 on ClinicalTrials.gov |
What this trial studies
This prospective observational cohort at the Clinical Emergency Hospital "Prof. Dr. Agrippa Ionescu" in Bucharest will enroll at least 400 adults admitted to surgery, internal medicine, infectious diseases, hematology, oncology, or ICU wards. Participants will undergo rectal swab screening for MDRO carriage at baseline (within 14 days prior to or at admission), on day 7, weekly thereafter, and at discharge, with a 30-day post-discharge telephone follow-up. Investigators will collect data on comorbidities, prior hospitalizations or surgeries, recent antibiotic exposure, and epidemiologic risk factors to link digestive carriage of ESBL, CRE, carbapenem-resistant non-fermenters (e.g., Pseudomonas aeruginosa, Acinetobacter baumannii) and VRE with subsequent healthcare-associated infections. The primary outcome is the cumulative risk of developing HAIs during hospitalization among MDRO carriers compared with non-carriers.
Who should consider this trial
Good fit: Adults (18+) admitted to one of the participating wards at the Bucharest hospital who can give informed consent are ideal candidates.
Not a fit: Patients under 18, those not admitted to the listed participating wards, or those unable to provide informed consent are unlikely to receive direct benefit from participation.
Why it matters
Potential benefit: If successful, the findings could help hospitals identify higher-risk patients and improve infection-prevention measures to reduce MDRO-related infections.
How similar studies have performed: Previous hospital cohort studies have shown that digestive carriage of ESBL and carbapenem-resistant organisms is associated with increased risk of subsequent infections, so this approach builds on existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years Admitted to participating wards Signed informed consent Exclusion Criteria: * withdrawal
Where this trial is running
Bucharest, Bucharest
- Emergency and Clinical Hospital Dr. Agrippa Ionescu — Bucharest, Bucharest, Romania (Recruiting)
Study contacts
- Study coordinator: Valeriu Gheorghita, Prof. Univ.
- Email: secretariat.agrippa@dcti.ro
- Phone: +40377720000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.