Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014, France
NCT Number: NCT03963297
Ceftolozane/tazobactam is a new antibiotic with broad spectrum activity. This molecule is currently one of the most active beta lactams against Pseudomonas aeruginosa and its spectrum of activity also includes enterobacteriaceae producing a broad spectrum beta-lactamase (EBLSE). Ceftolozane/tazobactam is currently marketed for the treatment of complicated intra-abdominal infections and complicated urinary tract infections. These intra-abdominal and urinary infections are mainly caused by enterobacteriaceae (Escherichia coli, Klebsiella pneumoniae) and more rarely by P. aeruginosa. Concerning enterobacteriaceae, French epidemiology reports a prevalence of BLSE of between 10 and 15% in E. coli and 10%-30% in K. pneumoniae.
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Notify Me18 year and older
All sexes
Observational
Paris, Île-de-France Region, 75014, France
Currently, the probabilistic treatment of these multi-resistant bacteria involves the use of carbapenems. Unfortunately, the increasing and unreasonable use of carbapenems invariably leads to the spread of even more resistant strains, BHRe (Emerging Highly Resistant Bacteria) including enterobacteriaceae producing carbapenemases. Thus, it is strongly recommended by health authorities to limit the use of carbapenems ("carbapenem savings") by promoting the use of therapeutic alternatives. Ceftolozane/tazobactam is one of those therapeutic alternatives for which an evaluation must be carried out. Currently, in addition to complicated intra-abdominal infections and complicated urinary tract infections, ceftolozane/tazobactam combination is used in clinical practice in gram-negative infections such as upper and lower respiratory infections and bacteremia. In any case, the choice of probabilistic antibiotic therapy must take into account local and regional epidemiological data. However, published data on the in vitro activity of ceftolozane/tazobactam remain limited, particularly in France (only one French epidemiological study on Gram-negative non-fermenting bacillus strains isolated in patients with cystic fibrosis). This study does not take into account in particular multi-resistant enterobacteriaceae producing BLSE for which ceftolozane/tazobactam remains effective (particularly in E. coli and K. pneumoniae).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 1 year
Value of the minimum inhibitory concentration (MIC) obtained for ceftolozane/tazobactam for each strain
Time frame: 1 year
Clinical profil of patients (yes/no) correlated with resistance or susceptibility of strains to ceftolozane/tazobactam
Time frame: 1 year
biochemical tests (ESBL NDP test and/or Carba NP test)
Time frame: 1 year
Molecular test (PCR + sequencing: blaCTX-M, blaTEM, blaSHV)
Time frame: 1 year
Molecular test (PCR + sequencing : blaGES, blaVEB and blaPER)
Fondation Hôpital Saint-Joseph
Other
Acronym: GMC-9
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