E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
This study will primarily address the question of the efficacy of intravenous fosfomycin 4 g b.i.d. in the therapy of patients presenting with complicated urinary tract infection. These data will be compared to meropenem administered intravenously at a dose of 2 g b.i.d. |
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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.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Primary objective(s): - To evaluate the clinical efficacy of fosfomycin versus meropenem in the therapy of patients presenting with complicated urinary tract infection.
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E.2.2 | Secondary objectives of the trial |
- To assess and compare laboratory parameters documenting systemic inflammation (e.g. CRP, leucocytes in blood) between treatment groups - To assess and compare laboratory parameters documenting complicated urinary tract infection (e.g. leucocytes in urine) between treatment groups - To compare microbiological eradication between treatment groups
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Written informed consent to participate in the study. 2. Male or female patient of 18 years of age or older. 3. Patient suffers from documented complicated urinary tract infection. 4. Requires intravenous broad-spectrum anti-microbial therapy 5. Patient suffers from renal dysfunction indicated by a creatinine clearance ≥40 ml/min as determined by the Cockcroft-Gault equation using actual body weight (Appendix 4). 6. Negative urine pregnancy test in females of childbearing potential 7. Patient is willing to participate in the study, follow protocol study 8. bacteruria 10 high 6/ml 9. CRP higher than 5mg/dl treatment regimen, and comply with all planned assessments.
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E.4 | Principal exclusion criteria |
1. Treatment with study drugs within the past three weeks prior to study enrolment. 2. No source of infection other than infection of the urinary tract 3. Current therapy with other antimicrobial agents 4. History of hypersensitivity to the study drug(s) or to drugs with similar chemical structures. 5. Patients submitted to the hospital with known pathogens resistant to study drugs 6. Patient with a neutrophils count <1000/m3. 7. Use of any other investigational therapy at the time of enrolment, or within 30 days or 5 half-lives of inclusion into, whichever is longer. 8. Patients unable or unwilling to adhere to the study-designated procedures and restrictions. 9. Unable to understand the nature, purpose and extent of the study
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E.5 End points |
E.5.1 | Primary end point(s) |
Clinical efficacy of anti-microbial therapy will be evaluated on study days 2, 7 and 10. A final test-of-cure visit will be performed on study day 10 (3 days after end of antimicrobial therapy). Laboratory analysis will be performed on study days 2, 7 and 10. |
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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 | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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 | Yes |
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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test of cure visit on Studa day 10, final post study visit on study day 14. |
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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 | 4 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |