Efficacy of Temocillin in Urinary Tract Infection Due to ESBL Producing and AmpC Hyperproducing Enterobacteriaceae
TEMO-ESBL
2 other identifiers
interventional
25
1 country
19
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Apr 2016
Typical duration for phase_4
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 27, 2015
CompletedFirst Posted
Study publicly available on registry
February 12, 2016
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2018
CompletedJune 6, 2018
June 1, 2018
2 years
November 27, 2015
June 1, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Microbiological efficacy at Test of Cure in patients microbiologically evaluable
The microbiological efficacy will be assessed by quantitative urine culture and defined as follows: * Eradication : \< 10\^3 CFU/mL of the baseline pathogen * Persistence : ≥ 10\^3 CFU/ml of the baseline pathogen * Superinfection : ≥ 10\^5 CFU/ml of another uropathogen during therapy * New infection : ≥ 10\^5 CFU/ml of another uropathogen after therapy * Relapse : eradication at TOC but ≥ 10\^3 CFU/mL of the baseline pathogen at FU Overall microbiological response will be determined as "unfavorable" if persistence or superinfection or new infection or relapse.
7 days post end of Temocillin Treatment
Secondary Outcomes (3)
Clinical efficacy in clinical evaluable group
3 weeks for end of Temocillin Treatment
Microbiological efficacy
3 weeks for end of Temocillin Treatment
Development of resistance to temocillin during treatment
3 weeks for end of Temocillin Treatment
Study Arms (1)
Temocillin
EXPERIMENTALTreatment 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).
Interventions
Treatment duration with a minimum of 5 days administration of the study drug: Temocillin (Negaban®) 6g/day (2g/tid) and as monotherapy.
Eligibility Criteria
You may qualify if:
- Age of at least 18 year old
- 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
You may not qualify if:
- Patient infected with a bacteria which is not an ESBL-producing or AmpC hyperproducing Enterobacteriaceae
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
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
Related Publications (5)
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.
PMID: 25433006BACKGROUNDBalakrishnan 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.
PMID: 21810837BACKGROUNDFournier 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.
PMID: 23433608BACKGROUNDSchulze 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.
PMID: 4029026BACKGROUNDDe 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.
PMID: 18070831BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jean Paul STAHL, PU-PH
University Hospital, Grenoble
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 27, 2015
First Posted
February 12, 2016
Study Start
April 1, 2016
Primary Completion
April 1, 2018
Study Completion
September 1, 2018
Last Updated
June 6, 2018
Record last verified: 2018-06