Trials / Completed
CompletedNCT03599999
Study of Adverse Effects Occuring in Patients Receiving an Antibiotic Treatment With Temocillin
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 26 (actual)
- Sponsor
- Centre Hospitalier Universitaire, Amiens · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Adverse events detection | type of adverse events detected during treatment with Temocillin and imputed to Temocillin |
Timeline
- Start date
- 2017-03-24
- Primary completion
- 2017-12-29
- Completion
- 2017-12-29
- First posted
- 2018-07-26
- Last updated
- 2018-09-28
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT03599999. Inclusion in this directory is not an endorsement.