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. MedDRA version: 9.1 Level: LLT Classification code 10046571 Term: Urinary tract infection
Conditions
Interventions
Trade Name: Fosfomycin 4g® “SANDOZ GES.M.H”
Product Name: fosfomycin
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: Fosfomycin
Sponsors
Medizinische Universität Wien, Abteilung für Interne Medizin I
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective(s): - To evaluate the clinical efficacy of fosfomycin versus meropenem in the therapy of patients presenting with complicated urinary tract infection. ;Secondary Objective: - 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 ;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. | — |
Countries
Austria
Outcome results
None listed