NCT05798351 Rectal Carriage of Carbapenemase Producing-Enterobacteriaceae on Admission to a French University Teaching Hospital
| NCT ID | NCT05798351 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Rectal Carriage of Carbapenemase Producing-Enterobacteriaceae |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,195 participants |
| Start Date | 2023-04-03 |
| Primary Completion | 2026-05-31 |
Trial Parameters
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Brief Summary
"The emergence and spread of highly resistant bacteria, including carbapenemase-producing Enterobacteriaceae (CPE), is a public health challenge given their rapid spread and the lack of active antibiotics against these bacteria. The spread of extended-spectrum β-lactamase-producing Enterobacteriaceae (ESBLE) since the early 2000s raises concerns about a potential similar spread of CPE in the coming years, especially in the healthcare setting. Early detection of CPE carriage in hospitalized patients with risk factors for CPE carriage is essential to prevent their spread in hospitals as well as to guide empiric antibiotic therapy for CPE carriers with signs of severe infection. However, the prevalence of CPE carriage on admission to hospital is not precisely known, nor are factors associated with CPE carriage. Hence, the investigators sought to determine the prevalence of CPE carriage and its risk factors in patients admitted to hospital, in order to identify the appropriate indications for CPE screening on admission to hospital. Secondly, the investigators aimed to estimate the annual number of patients with CPE carriage who would not have been identified with the current targeted screening policy as well as to estimate the annual number of secondary cases that could be prevented if a universal screening policy was applied on admission (i.e. for all hospitalized patients, not just those with risk factors). Therefore, the investigators plan to carry out a systematic screening for rectal carriage of CPE on admission in a sample of patients hospitalized at the Bichat - Claude-Bernard Hospital. Inclusion criteria will include: Age ≥ 18 years, admission to a medical, surgical, obstetrical or intensive care unit at Bichat - Claude-Bernard Hospital in the previous 72 hours, no objection to participating in the study. Rectal swabs will be taken from all included patients for detection of CPE and/or ESBLE. Patients' characteristics, including sociodemographic data, country of birth and residence, clinical ward, current antibiotic treatment and that in the last 3 months, travel abroad and last geographical areas visited, hospitalization in France and abroad, and history of CPE and ESBLE carriage or infection in the previous year, will be collected by questionnaire and from medical records. "
Eligibility Criteria
Inclusion criteria * Age ≥ 18 years * Admission to a medical, surgical, obstetrical or intensive care unit at Bichat - Claude-Bernard Hospital in the previous 72 hours * No objection to participating in the study Non-inclusion criteria * Admission to Bichat - Claude-Bernard Hospital \> 72 hours before inclusion * Readmission to the same ward after discharge * Hospitalization in a rehabilitation unit or a long-stay unit * Non affiliation to social security * Patient under legal protection