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NCT04190316
Factors Influencing the Fecal Relative Abundance of ESBL-producing Enterobacteriaceae in Intensive Care (BLSE-REA).
NA trial testing Evaluation of fecal RA and environmental contamination of ESBL-PE carrier in ICU in ESBL-producing Enterobacteriaceae Infections in 200 participants. Status unknown.
1 January 2022
Quick facts
| Lead sponsor | University Hospital, Angers |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 200 |
| Start date | 1 January 2020 |
| Primary completion | 1 January 2022 |
| Estimated completion | 1 January 2022 |
Drugs / interventions tested
- Evaluation of fecal RA and environmental contamination of ESBL-PE carrier in ICU
Conditions studied
- ESBL-producing Enterobacteriaceae Infections — all drugs for ESBL-producing Enterobacteriaceae Infections →
Sponsor
University Hospital, Angers
Who can join
18 and older, any sex, with ESBL-producing Enterobacteriaceae Infections. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Extended-Spectrum Beta-Lactamases (ESBL)-Producing Enterobacteriaceae (PE) pose a major problem among antimicrobial resistance. The worldwide spread of theses bacteria may be responsible for 10 million death in 2050. Infection with ESBL-PE are associated with a worse prognosis because of delay in the start of adequate antibiotic treatment, especially for severe infections. It has been proposed to identify colonized patients to predict the risk of infection and the risk of nosocomial cross transmission. This qualitative approach has limit as only 5 to 20% of patients will develop an infection with ESBL-PE. The fecal relative abundance (RA) of ESBL-PE is a ratio of ESBL-PE among enterobacteriaceae that could identify high-risk patients of infection or cross transmission. ESBL-PE RA may be highly variable in patient with antibiotic exposure depending on the molecule received but dynamic data is missing. The aim of this study is to identify the factor that influence the fecal RA of ESBL-PE in ICU and to evaluate the association between different level of fecal RA and infection or cross transmission with an ESBL-PE.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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- PubMed search for NCT04190316
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04190316 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Angers
- Last refreshed: 9 December 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04190316.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing