Temocillin in ESBL-Enterobacteriaceae Infections
Condition: Infectious Disease
MeSH terms: Communicable Diseases; Infections
Study type: Observational

Summary: 
      Because of the increasing incidence of infections with multi-drug resistant
      enterobacteriaceae, we need alternative treatments to spare carbapenems. Temocillin could be
      an interesting option but its position is only defined for the curative treatment of urinary
      tract infections. We would like to explore others indications comparing two groups : one
      using temocillin empirically for treatment or prophylaxis and the second using it in second
      line whatever the indication is.
    

Detailed description: 
      We will retrospectively include every patient who received at least 24 hours of temocillin
      for the treatment of an extended-spectrum beta-lactamase Enterobacteriaceae (ESBL-E)
      infection from January to December 2016 in two university hospitals (centres 1 and 2). Each
      treatment indication will be recorded including off-label prescriptions. Patients will be
      classified in 2 treatment groups: group 1 received a probabilistic antibiotherapy first (3GC
      or carbapenem or piperacillin/tazobactam or fluoroquinolones) followed by temocillin as
      second line treatment. Group 2 was defined by the use of temocillin as first line treatment
      or as prophylaxis.

      Data collection : Clinical, biological and pharmaceutical data will be retrieved from medical
      chart. The patient's referring physician and/or the department will be contacted for further
      information on missing data. Remote outcomes will be retrieved either by hospital records if
      the patient is rehospitalized in the meantime or by contacting directly the patient by phone
      or e-mail. Demographic characteristics, comorbidities, type and location of infection,
      treatment, side effects, biological results, follow-up duration, treatment and outcome will
      be collected. For all antibiotics, doses, route and scheme administration, duration, first,
      second and third line of antibiotic (after temocillin) will be retrieved from medical chart.

      Case definition and outcome: Treatment failure in curative use is defined by the persistence
      of clinical symptoms 72h after starting the antibiotic and/or clinical worsening leading to a
      switch to broad-spectrum antibiotic and/or recurrence of initial symptoms and/or
      identification of the same bacterial species with the same susceptibility pattern as
      initially observed (same or new location). Treatment failure in prophylactic use is defined
      by the persistence of the enterobacteria according to the indication of prophylaxis (e.g.
      urine). All deaths and lost-to-follow-up will be considered as failures (worst case
      scenario). Treatment success is defined by the absence of failure in the four weeks after
      treatment. We will use the Sequential Organ Failure Assessment (SOFA) score in predicting
      mortality in patients with ESBL-E infections included in our study.

      Microbiological definitions : The susceptibility of the isolates to temocillin wil be
      determined by disc diffusion method (Biorad®, Marnes-la-Coquette, France) according to the
      guidelines of the CA-SFM ("Comité de l'Antibiogramme - Société Française de Microbiologie",
      Antibiogram Committee - French Society of Microbiology ). The Minimum Inhibitory
      Concentration (MIC) of temocillin will be determined by E-test (bioMérieux®, Marcy l'Étoile,
      France) on Mueller-Hinton agar using the manufacturer's instructions. MIC results will be
      also interpreted according to the 2016 guidelines of the CA-SFM.18
    

Intervention name(s): Temocillin
Intervention type(s): Other
Intervention description(s): To evaluate the clinical course of patients who received temocillin. To evaluate the efficacy and safety of temocillin in different situations Enterobacteriaceae ESBL infections
Intervention MeSH terms: Temocillin
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patient over 18, hospitalized in any department from 01/01/16 to 12/15/16 at CHU
        Pitié-Salpêtrière or CHU Tenon, having received at least 24 hours of temocillin for an ESBL
        enterobacteria infection / colonization whatever or the indication.
      
Keywords: extended-spectrum-β-lactamase-producing Enterobacteriaceae; carbapenem-sparing agent; urinary tract infection; bacteraemia; temocillin