An observational study in Carbapenem-induced Resistance, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 5 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-05-13.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
The use of carbapenems, very broad spectrum antibiotics of last resort, is becoming more common due to the increased prevalence in the hospital and community of extended spectrum β-lactamase (ESBL) producing gram-negative bacilli (GNB), including CTX-M type, which are resistant to all other β-lactam antibiotics. Meanwhile, it creates a selective pressure towards emergence of strains which are also resistant to carbapenems, placing patients in a catastrophic situation of therapeutic dead-end. A better understanding of the mechanisms of emergence of BGN resistant to carbapenems is necessary to optimize their use and undertake preventive measures to preserve their effectiveness. The aim of the study is to evaluate and describe the emergence of carbapenem-induced resistant GNB in patient intestinal microflora.
The use of carbapenems, very broad spectrum antibiotics of last resort, is becoming more common due to the increased prevalence in the hospital and community of extended spectrum β-lactamase (ESBL) producing gram-negative bacilli (GNB), including CTX-M type, which are resistant to all other β-lactam antibiotics. Meanwhile, it creates a selective pressure towards emergence of strains which are also resistant to carbapenems, placing patients in a catastrophic situation of therapeutic dead-end. A better understanding of the mechanisms of emergence of BGN resistant to carbapenems is necessary to optimize their use and undertake preventive measures to preserve their effectiveness.
Hypotheses: Carbapenems induce in treated patients the emergence of resistant GNB in intestinal flora and have an impact on colonization resistance of the gut microbiota.
Primary objective: To determine the frequency of emergence of carbapenems resistant GNB in the intestinal flora at the end of a treatment by imipenem or ertapenem.
Secondary objective(s):
Primary endpoint: Presence of carbapenem resistant GNB in the stool at the end of treatment in patients who did not before, after culture on selective media.
Secondary endpoints:
Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
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hospitalized patients initiating a carbapenem treatment
Exclusion Criteria :
Secondary exclusion criteria :
imipenem-treated patients
ertapenem-treated patients
presence of carbapenem-resistant gram-negative bacteria at the end of carbapenem treatment in faeces of patients who were free of carbapenem-resistant gram-negative bacteria before the beginning of treatment
faecal bacterial growth on selective culture media
Time frame: at the end of carbapenem treatment period which usually lasts between 2 and 15 days
presence of carbapenem-resistant gram-negative bacteria in patient faeces before carbapenem treatment, at day 3 of carbapenem treatment and at day 15 et day 30 after the end of carbapenem treatment
faecal bacterial growth on selective culture media
Time frame: before, at day 3 of carbapenem treatment and at day 15 and day 30 after the end of carbapenem treatment
This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris