Clinical trial NCT03599999: Study of Adverse Effects Occuring in Patients Receiving an Antibiotic Treatment With Temocillin
Official title: Study of Adverse Effects Occuring in Patients Receiving an Antibiotic Treatment With Temocillin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bacterial Infection With One or More Extended Spectrum Betalactamases Remaining Susceptible to Temocillin
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This concerns patients over the age of 18 years old with documented bacterial infection with one or more extended spectrum betalactamases remaining susceptible to Temocillin.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: number and type of adverse events detected during treatment with Temocillin and imputed to Temocillin
timeFrame: 7 days after the end of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens-Picardie
Study officials:
References: