Efficacy of Temocillin in Urinary Tract Infection Due to ESBL Producing and AmpC Hyperproducing Enterobacteriaceae
NCT ID: NCT02681263
Last Updated: 2018-06-06
Study Results
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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UNKNOWN
PHASE4
25 participants
INTERVENTIONAL
2016-04-30
2018-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Temocillin
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).
Temocillin
Treatment duration with a minimum of 5 days administration of the study drug: Temocillin (Negaban®) 6g/day (2g/tid) and as monotherapy.
Interventions
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Temocillin
Treatment duration with a minimum of 5 days administration of the study drug: Temocillin (Negaban®) 6g/day (2g/tid) and as monotherapy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient benefits from social security
* Signed informed consent
* A urinary tract infection due to a confirmed ESBL producing strain (detected by the use of a rapid diagnostic test applied on the urine) requiring parenteral antimicrobial therapy
* Hospitalized patient
* For women able to procreate: Use of an acceptable method of birth control throughout the study. Acceptable methods of birth control are: oral contraceptives, intrauterine device (IUD), diaphragm with spermicide and condom. (All forms of hormonal contraception are acceptable
Exclusion Criteria
* Patients infected with a strain sensible to both fluoroquinolones and trimethoprim/sulfamethoxazole
* Patients infected with a strain resistant to temocillin
* Hospital-acquired urinary tract infection (defined as a urinary infection that occurred at least 48h post admission in the hospital)
* Patients has received any dose of active antimicrobial therapy (an antibiotic to which the infecting bacterium is susceptible) in the last 48h (prior to enrolment) except ≤ 2 dose of gentamicin.
* Patients presenting another site of infection than urinary (except onset of bacteraemia from urinary tract origin) due to Gram negative bacteria.
* Patients needing concomitant antimicrobial therapy.
* Septic shock
* Children (up to 18 years old)
* Women who is pregnant, breastfeeding, or expecting to conceive at any time during the study (pregnancy test will be conducted for woman without menopause)
* Patients with any kind of urinary/bladder catheter (JJ ureteral probe, …)
* Hypersensitivity to the active substance, to penicillins or to any other type of beta-lactam agent
* Chronically dialyzed patients
* Patients having a creatinine clearance \< 30 mL/min
* Complete obstruction of the urinary tract
* Perinephretic or intrarenal abscesses
* Tutorship or curatorship patient
* Patient unable to give his consent
18 Years
ALL
No
Sponsors
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French National Network of Clinical Research in Infectious Diseases (RENARCI)
OTHER
University Hospital, Grenoble
OTHER
Responsible Party
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Principal Investigators
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Jean Paul STAHL, PU-PH
Role: STUDY_CHAIR
University Hospital, Grenoble
Locations
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CH Ajaccio
Ajaccio, , France
CH Annecy Genevois
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
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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2015-004178-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
38RC15.213
Identifier Type: -
Identifier Source: org_study_id
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