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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-004178-14 | EudraCT Number |
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| Name | Class |
|---|---|
| French National Network of Clinical Research in Infectious Diseases (RENARCI) | OTHER |
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The present study aims at demonstrating the efficacy of temocillin in the treatment of UTI requiring parenteral therapy due to a confirmed ESBL producing or AmpC hyperproducing Enterobacteriaceae, resistant to quinolones and Bactrim® in France. In addition, this study will describe and support the use of high dose (6g/day) of temocillin which could be of interest for the treatment urinary tract infection due to multi-resistant bacteria having high MIC (up to 32 mg/L). The investigators will also evaluate the tolerance of the drug by monitoring the adverse event and the incidence of eventual Clostridium difficile associated infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Temocillin | Experimental | Treatment duration with a minimum of 5 days administration of the study drug: Temocillin (Negaban®) 6g/day (2g/tid) and as monotherapy. Total antibiotic treatment between 10 and 14 days according to local guidelines (up to 21 days in immunosuppressed patients). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Temocillin | Drug | Treatment duration with a minimum of 5 days administration of the study drug: Temocillin (Negaban®) 6g/day (2g/tid) and as monotherapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Microbiological efficacy at Test of Cure in patients microbiologically evaluable | The microbiological efficacy will be assessed by quantitative urine culture and defined as follows:
| 7 days post end of Temocillin Treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical efficacy in clinical evaluable group | Each patient's response will be categorized as cure (resolution of all clinical symptoms), improvement (normalization of body temperature but persistence of either urinary syndrome or flank pain) or failure (persistence of baseline clinical symptoms or emergence of new symptoms related to UTI). | 3 weeks for end of Temocillin Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean Paul STAHL, PU-PH | University Hospital, Grenoble | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Ajaccio | Ajaccio | France | ||||
| CH Annecy Genevois |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25433006 | Background | Laterre PF, Wittebole X, Van de Velde S, Muller AE, Mouton JW, Carryn S, Tulkens PM, Dugernier T. Temocillin (6 g daily) in critically ill patients: continuous infusion versus three times daily administration. J Antimicrob Chemother. 2015 Mar;70(3):891-8. doi: 10.1093/jac/dku465. Epub 2014 Nov 27. | |
| 21810837 | Background |
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| Microbiological efficacy | The microbiological efficacy will be assessed by quantitative urine culture and defined as follows:
| 3 weeks for end of Temocillin Treatment |
| Development of resistance to temocillin during treatment | The acquisition of resistance will be monitored in the central laboratory and is defined as an increase in MIC of at least 4 dilutions. | 3 weeks for end of Temocillin Treatment |
| Annecy |
| France |
| APHP - Avicenne Hospital | Bobigny | France |
| APHP - Beaujon Hospital | Clichy | France |
| CHU de Martinique | Fort de France | France |
| CHU de Grenoble | Grenoble | France |
| APHP - Bicêtre Hospital | Le Kremlin-Bicêtre | France |
| CHU de Lille | Lille | France |
| CHU de Nantes | Nantes | France |
| CHU de Nice | Nice | France |
| APHP - Bichat Hospital | Paris | France |
| APHP - Cochin Hospital | Paris | France |
| APHP - St Louis | Paris | France |
| CH de Perpignan | Perpignan | France |
| CHU de Pointe à Pitre | Pointe à Pitre | France |
| CHU de Poitiers | Poitiers | France |
| CHU de Rouen | Rouen | France |
| CHU de Saint Etienne | Saint-Etienne | France |
| CHU de Tours | Tours | France |
| Balakrishnan I, Awad-El-Kariem FM, Aali A, Kumari P, Mulla R, Tan B, Brudney D, Ladenheim D, Ghazy A, Khan I, Virgincar N, Iyer S, Carryn S, Van de Velde S. Temocillin use in England: clinical and microbiological efficacies in infections caused by extended-spectrum and/or derepressed AmpC beta-lactamase-producing Enterobacteriaceae. J Antimicrob Chemother. 2011 Nov;66(11):2628-31. doi: 10.1093/jac/dkr317. Epub 2011 Aug 2. |
| 23433608 | Background | Fournier D, Chirouze C, Leroy J, Cholley P, Talon D, Plesiat P, Bertrand X. Alternatives to carbapenems in ESBL-producing Escherichia coli infections. Med Mal Infect. 2013 Feb;43(2):62-6. doi: 10.1016/j.medmal.2013.01.006. Epub 2013 Feb 19. |
| 4029026 | Background | Schulze B, Heilmann HD. Treatment of severe infections with temocillin. Clinical and bacteriological evaluation. Drugs. 1985;29 Suppl 5:207-9. doi: 10.2165/00003495-198500295-00046. |
| 18070831 | Background | De Jongh R, Hens R, Basma V, Mouton JW, Tulkens PM, Carryn S. Continuous versus intermittent infusion of temocillin, a directed spectrum penicillin for intensive care patients with nosocomial pneumonia: stability, compatibility, population pharmacokinetic studies and breakpoint selection. J Antimicrob Chemother. 2008 Feb;61(2):382-8. doi: 10.1093/jac/dkm467. Epub 2007 Dec 10. |
| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C031367 | temocillin |
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