An randomized, controlled, investigator-blinded, prospective, mono-centre study to evaluate the efficacy of fosfomycin versus meropenem in patients with complicated urinary tract infections - urosepsis/fosfo vs. meropenem

Conditions: 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: 9.1Level: LLTClassification code 10046571Term: Urinary tract infection

Registration Number: EUCTR2007-005112-37-AT

Lead Sponsor: Medizinische Universität Wien, Abteilung für Interne Medizin I

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 240

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary objective(s):<br>-To evaluate the clinical efficacy of fosfomycin versus meropenem in the therapy of patients presenting with complicated urinary tract infection.<br>;Secondary Objective: -To assess and compare laboratory parameters documenting systemic inflammation (e.g. CRP, leucocytes in blood) between treatment groups<br>-To assess and compare laboratory parameters documenting complicated urinary tract infection (e.g. leucocytes in urine) between treatment groups<br>-To compare microbiological eradication between treatment groups <br>;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.

Secondary Outcome Measures