Impact of Beta-lactams on the Microbiota and Relative Fecal Abundance of Mulltidrug Resistant Bacteria
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|ClinicalTrials.gov Identifier: NCT03338738|
Recruitment Status : Recruiting
First Posted : November 9, 2017
Last Update Posted : August 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Enterobacterial Infection||Diagnostic Test: Stool culture ans swab||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Impact of Beta-lactams on the Microbiota and Relative Fecal Abundance of Multidrug Resistant Bacteria Ans Its Importance on Infectious Episodes in Hospitalized Patients|
|Actual Study Start Date :||July 19, 2018|
|Estimated Primary Completion Date :||July 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Experimental: Patients with ESBL, antibiotic pressure
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.
Diagnostic Test: Stool culture ans swab
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.
- percentage of EBLSE [ Time Frame: Day 60 ]ratio of number of colony of enterobacteria BLSE on number of total bacteria colony
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03338738
|Contact: PILMIS Benoit, MD||01 44 12 33 firstname.lastname@example.org|
|Contact: PHILIPPART Francois, MDemail@example.com|
|Groupe Hospitalier Paris Saint Joseph||Recruiting|
|Paris, Ile-de-France, France, 75014|
|Contact: Helene BEAUSSIER, PharmD, PhD|
|Study Chair:||ZAHAR Jean Ralph, Professor||AVICENNE HOSPITAL|
|Study Director:||LE MONNIER Alban, Professor||GHPSJ|