EUCTR2007-005112-37-AT
Active, not recruiting
Not Applicable
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
Medizinische Universität Wien, Abteilung für Interne Medizin I0 sites240 target enrollmentJuly 1, 2008
ConditionsThis 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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- 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.
- Sponsor
- Medizinische Universität Wien, Abteilung für Interne Medizin I
- Enrollment
- 240
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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.
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
Outcomes
Primary Outcomes
Not specified
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