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

Completed

• Conditions: Bacterial Infection With One or More Extended Spectrum Betalactamases Remaining Susceptible to Temocillin

• Registration Number: NCT03599999
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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.

Study Timeline

• Study Start: 2017-03-24
• Primary Completion: 2017-12-29
• Study Completion: 2017-12-29
• Study First Submitted: 2018-07-16
• Study First Submitted QC: 2018-07-24
• Study First Posted: 2018-07-26
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-27
• Last Update Posted: 2018-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
number and type of adverse events detected during treatment with Temocillin and imputed to Temocillin	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.

Trial Locations

Locations (1)

CHU Amiens-Picardie; 🇫🇷 Amiens, France