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Completed

NCT Number: NCT05413772

Temocillin in ESBL-Enterobacteriaceae Infections

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pitié-Salpêtrière University Hospital, Paris, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years
  • All patients who received at least 24 hours of temocillin for the treatment of ESBL enterobacteriaceae infection / colonization from January to December 2016 in the university hospitals of Tenon and Pitié Salpêtrière. All indications, including excluding recommendations.
  • Informed and not opposed to the use of their data

Exclusion criteria

  • Patient < 18 years
  • Pregnancy
  • Refusal to participate
  • Multi-resistant bacterial infection not treated with temocillin
  • Temocillin resistant bacteria

Treatment and study plan

Temocillin

Other

To evaluate the clinical course of patients who received temocillin. To evaluate the efficacy and safety of temocillin in different situations Enterobacteriaceae ESBL infections

Primary outcomes

  1. Number of patients with failure or success

    Time frame: 10 days

    Definition of failure: persistence of clinical symptoms 72h after starting the antibiotic and/or clinical worsening (ie : fever, cough, sputum, urinary symptoms, diarrhea...) leading to a switch to broad-spectrum antibiotic and/or recurrence of initial symptoms and/or identification of the same bacterial species, retrieved in collection samples, with the same susceptibility pattern as initially observed (same or new location)

Secondary outcomes

  1. Number of patients with treatment related adverse events as assessed by CTCAE v6.0

    Time frame: 28 days

    Any side effect described in the medical file : Clostridium difficile colitis, renal failure, rash, for example.

    Collection of information in the medical file in order to explore the reason of failure : analyse of others potential failure's causes (other cause of fever for example)

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Practical Use of Temocillin in Enterobacteriaceae Resistant to Third Generation of Cephalosporins: Experience of Two French University Hospitals

Acronym: TMO2016

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 10, 2022
Registry last updated
Feb 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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