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In the 1980s, the first cases of ESBL-producing Enterobacteriaceae infections were described in the 1980s and later spread worldwide. The prevalence of EBLSE infections, particularly among E. coli and K. pneumoniae, has soared sharply since the turn of the century. The rate of resistance to third generation cephalosporins among clinical strains in cooperation with Santu00e9 Publique France was 10. 2% for Escherichia coli and 28. 8% for Klebsiella pneumoniae. The two most commonly used carbapenems in clinical use, Imipenem and meropenem, are Imipenem and meropenem. In addition, each antibiotic therapy does not effect the intestinal microbiota in the same way, and it appears that antibiotics with a high incidence against tight anaerobic species and/or a high biliary elimination are the most beneficial, although not all antibiotic therapy does. In a setting where multi-resistant bacteria prevalence is on the rise of MRE and intestinal microbiota at the individual level, it seems that doing a research aimed at comparing the effect of imipenem and meropenem on the evolution of MRE and intestinal microbiota seems to be highly relevant. Actually, the typical care of patients with an infection that necessitates treatment with a carbapenem is different between the two participating centers. Patients at Avicenne Hospital and Medicine are treated with meropenem and patients at the Paris Saint-Joseph Hospital Group with imipenem, according to the usual routine administration of patients in these two participating centers, except in the case of a need for a higher daily dose due to the neurological toxicity of imipenem in high doses.
Source link: https://clinicaltrials.gov/ct2/show/NCT05516433
On Day 1 of the study's visit, a Screening Visit, a Baseline visit on Day 1 of the study's first infusion, daily treatment visits from Day 2 to Day 14, an End of Treatment visit within 24 hours after the last infusion, a Test of Cure tour on Day 28, and a Late Follow Up visit on Day 45 will be included in the study. The number of people with cUTI will be no more than 75% of the study population, according to the study's estimates. According to a central randomization scheme, subjects will be randomized in a 2:1 ratio to the ATM AVI treatment arm or the BAT treatment arm after obtaining written informed consent and confirming eligibility. In subjects where plasma samples and microbiological response data have been collected, subjects who were randomly assigned to the ATM AVI treatment arm will be tested for population pharmacokinetic assessments and PK/pharmacodynamic relationships.
Source link: https://clinicaltrials.gov/ct2/show/NCT03580044
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