E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients presenting urinary tract infections due to Extended Spectrum Beta-Lactamases producing or AmpC hyperproducing Enterobacteriaceae. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10046571 |
E.1.2 | Term | Urinary tract infection |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10002737 |
E.1.2 | Term | Antibiotic resistant strain |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Demonstrate efficacy and safety of temocillin in urinary tract infections due to Extended Spectrum Beta-Lactamases producing or AmpC hyperproducing Enterobacteriaceae. |
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E.2.2 | Secondary objectives of the trial |
Monitor ESBL and AmpC faecal carriage (optional for the patients) and the incidence of Clostridium difficile infection in patients treated by temocillin
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• patient presenting a complicated urinary tract infection (i.e. acute pyelonephritis, UTI in men, or UTI associated with obstruction, foreign bodies, or urologic abnormalities) due to a confirmed ESBL producing or AmpC hyperproducing Enterobacteriaceae susceptible to temocillin requiring parenteral antimicrobial therapy • community or hospital acquired infecting bacteria • signed informed consent
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E.4 | Principal exclusion criteria |
• patients infected with a strain resistant to temocillin (if included at first, then the patient will be kept in the ITT group, therapy will be switched and the patient will be followed for the same time as other enrolled patients). • patients having received an active antimicrobial therapy during the 48h before the beginning of temocillin treatment (i.e. having received an antibiotic to which the infecting bacteria is susceptible) except temocillin (i.e. if the patient has been treated empirically with temocillin, they will not be excluded) • patients presenting with another site of infection than urinary (except onset of bacteremia from urinary tract origin) due to Gram negative bacteria • patients needing concomitant antimicrobial therapy with the exception of benzylpenicillin • uncomplicated cystitis • complete obstruction of the urinary tract • prostatitis • perinephretic or intrarenal abscesses • renal transplant • children (up to 18 years old) • pregnancy or lactation • chronically dialyzed patients • immunocompromising therapy or illness • known allergy to penicillin
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E.5 End points |
E.5.1 | Primary end point(s) |
Eradication rate in the Modified Intent To Treat population at the End Of Therapy |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |