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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-24

Study Completion Date

2017-12-29

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Adverse events detection

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

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Amiens-Picardie

Amiens, , France

Site Status

Countries

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France

Other Identifiers

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PI2017_843_0003

Identifier Type: -

Identifier Source: org_study_id