NCT03338738|Completed
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Sponsor study identifier
interventional
19
1 country
1
Study Start
July 19, 2018
Actual (reported)Primary Completion
March 31, 2021
Actual (reported)Study Completion
May 28, 2021
Actual (reported)The global spread of ESBL-producing enterobacteria (EBLSE) poses a real public health problem. The exposure of patients to antibiotic therapy leads to an increase in resistant bacterial populations within the digestive flora. As a result, the diagnosis of digestive colonization by EBLSE is an event that has become common in hospitalized patients in intensive care / intensive care under high pressure antibiotics. The aim of this work is to study the impact of beta-lactams frequently prescribed on the microbiota and the emergence of multiresistant bacteria in the digestive flora and to evaluate, in colonized patients, the factors associated with the occurrence of an infectious episode. In particular, the impact of the relative fecal abundance of ESBL enterobacteriaceae on the occurrence of this event will be studied.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 28, 2021
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 19, 2017
Actual (reported)November 9, 2017
Actual (reported)July 19, 2018
Actual (reported)March 31, 2021
Actual (reported)May 28, 2021
Actual (reported)percentage of EBLSE
ratio of number of colony of enterobacteria BLSE on number of total bacteria colony
Day 60
Patients with ESBL, antibiotic pressure will be included. On the day of inclusion, a stool culture is performed on the first stool issued after the start of antibiotic therapy in order to evaluate the initial flora and the relative initial faecal abundance of multidrug-resistant bacteria. In the absence of stool emission by the patient, a rectal swab will be performed. 72 hours after initiation of antibiotic therapy, a blood sample (5 ml) will be taken to determine plasma concentrations of antibiotics. In addition, a stool sample will be taken at 72 hours after the start of antibiotic therapy, at the end of antibiotic therapy and 60 days after this end to evaluate the change in initial flora and relative faecal abundance of ESBL-producing enterobacteria.
Patients with ESBL enterobacteria, antibiotic pressure are patients with ESBL positive result diagnosed by stool culture and a rectal swab. The intervention correspond to addition of 4 stool samples (or 4 rectal swabs in the absence of stool emission) and a blood sample.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014, France
Pilmis B, Mizrahi A, Pean de Ponfilly G, Philippart F, Bruel C, Zahar JR, Le Monnier A. Relative faecal abundance of extended-spectrum beta-lactamase-producing Enterobacterales and its impact on infections among intensive care unit patients: a pilot study. J Hosp Infect. 2021 Jun;112:92-95. doi: 10.1016/j.jhin.2021.03.022. Epub 2021 Mar 29.
ZAHAR Jean Ralph, Professor
AVICENNE HOSPITAL
LE MONNIER Alban, Professor
GHPSJ
19 participants (actual enrollment reported by the registry).
First Submitted
October 19, 2017
First Posted
November 9, 2017
Study Start
July 19, 2018
Actual (reported)Qnr Genes in Enterobacteriaceae
Contact the study team to confirm eligibility.
Primary Completion
March 31, 2021
Actual (reported)Study Completion
May 28, 2021
Actual (reported)Last Updated
June 2, 2021
Record last verified: 2021-05
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Source: ClinicalTrials.gov.
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