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OpenTrials
Completed

NCT Number: NCT03599999

Study of Adverse Effects Occuring in Patients Receiving an Antibiotic Treatment With Temocillin

The Temocillin prescription frequency may be increased in order to reduce the use of carbapenems to reduce the progressive increase in carbapenem resistance observed in recent years. The investigators wish to study the responsibility of Temocillin in the occurrence of adverse effects in patients in the hospital of Amiens receiving a treatment containing this molecule.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Amiens-Picardie

Amiens, 80054, France

About this study

The study "Continuous versus intermittent infusion of temocillin, a directed spectrum penicillin for intensive care patients with nosocomial pneumoniae: stability, compatibility, population pharmacokinetic studies and breakpoint selection, R. De Jongh, et al, 2007 ", the author states that no adverse effects were found following injection of Temocillin. In the study "Temocillin use in England: clinical and microbiological efficacies in infections caused by extentedspectrum and / or derepressed AmpC β-lactamase-producing Enterobacteriaceae, I. Balakrishnan, et al, 2011, the author faced two cases of Clostridium difficile with a positive toxin test. The first patient received three doses of Amoxicillin / clavulanic acid followed by one week's treatment with Temocillin. This one has developed Clostridium difficile diarrhea on the last day of antibiotic treatment. The second patient did not not received Temocillin in the 6 weeks prior to diarrhea but received 8 days of Meropenem just before this diarrhea. In all cases, Temocillin can not be clearly attributed to this adverse effect and no patient developed pseudomembranous colitis.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • documented bacterial infection with one or more extended spectrum betalactamases remaining susceptible to Temocillin

Exclusion criteria

  • History of hypersensitivity to betalactamines (rash,…)
  • Patient participating in another biomedical research on a drug to avoid the risk of interactions drug
  • Grafted patient
  • Immunocompromised patient
  • Dialysis patient (except hemodialysis patient and dialysis patient peritoneal)

Treatment and study plan

Adverse events detection

Drug

type of adverse events detected during treatment with Temocillin and imputed to Temocillin

Primary outcomes

  1. number and type of adverse events detected during treatment with Temocillin and imputed to Temocillin

    Time frame: 7 days after the end of treatment

    Each reported case will be, first, analyzed by the principal investigator (an infectiologist), who will also be responsible for collecting information to fill out the data collection sheets and, secondarily, by the CRPV d'Amiens, which will bring its expertise in particular to define the imputability of Temocillin to the undesirable effect detected.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: Témocilline

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jul 26, 2018
Registry last updated
Sep 28, 2018

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

View the official ClinicalTrials.gov record (opens in a new tab)

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.