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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-005912-41 | EudraCT Number |
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No patient has been included in 9 months because of strict incl/excl criteria
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This study is aimed at demonstrating the efficacy of temocillin in the treatment of complicated Urinary Tract Infection (UTI) due to confirmed Extended Spectrum Beta-Lactamases (ESBL) producing or AmpC hyperproducing Enterobacteriaceae in the United Kingdom.
The spectrum of activity together with the route of excretion of temocillin makes it a good candidate for the treatment of urinary tract infections. Several studies have shown very good clinical and microbiological activity in uncomplicated and complicated cystitis and pyelonephritis in adults and in pyelonephritis in children older than 2 months. However there is no specific study performed on Urinary Tract Infections due to broad spectrum ß-lactamases producing strains.
In this context, this study is aimed at demonstrating the efficacy of temocillin in the treatment of complicated Urinary Tract Infection due to confirmed Extended Spectrum Beta-Lactamases (ESBL) producing or AmpC hyperproducing Enterobacteriaceae in the United Kingdom. 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 group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Temocillin | Drug | Antibiotic treatment |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Microbiological cure | Eradication : < 10,000 Colony forming Unit/mL (CFU/mL) of the baseline pathogen
| End of treatment (minimum 5 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical cure | Clinical status of the patient will be classified as
| End of treatment (minimum 5 days) |
| Development of resistance during treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter M Hawkey, Professor | Birmingham Public Health Laboratory | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham Heartlands Hospital | Birmingham | United Kingdom |
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| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C031367 | temocillin |
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Acquisition of resistance to temocillin during treatment on a microbiological point of view |
| End of treatment (minimum 5 days) |
| Infection relapses monitored over 4-6 weeks |
| End of follow-up (up to 6 weeks) |
| Monitoring of AE | Record of any untoward medical occurrence in a clinical trial patient administered temocillin and which does not necessarily have to have a causal relationship with the treatment. | From day 0 to up to 6 weeks |
| ESBL & AmpC fecal carriage (optional) | All isolates of included patients will be kept frozen at -80°C and sent to the central laboratory for ESBL/AmpC confirmation and typing through molecular techniques. Pulse field gel electrophoresis will be performed on isolates from the same species for determination of clonality. | Start and end of treatment (minimum 5 days) |
| Incidence of C. difficile infection | Clostridium difficile infection (CDI) is defined as recommended by the HPA Steering Group on Healthcare Associated Infection 35 : one episode of diarrhoea, defined either as stool loose enough to take the shape of a container used to sample it, or as Bristol Stool Chart types 5-7, which is not attributable to any other cause including medicines which occurs at the same time as a positive toxin assay (with or without a positive C. difficile culture) and/or endoscopic evidence of pseudomembranous colitis. | From day 0 to up to 6 weeks |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |