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

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

— Témocilline  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03599999
• Other study ID #: PI2017_843_0003
• Status: Completed
• Start date: March 24, 2017
• Est. completion date: December 29, 2017

Study information

• Verified date: September 2018
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 29, 2017
• Est. primary completion date: December 29, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

Drug:
• Adverse events detection
type of adverse events detected during treatment with Temocillin and imputed to Temocillin

Locations

Country	Name	City	State
France	CHU Amiens-Picardie	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number and type of adverse events detected during treatment with Temocillin and imputed to Temocillin	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.	7 days after the end of treatment