FOsfomycin Randomised controlled trial for E.coli Complicated urinary tract infections as Alternative Stepdown Treatment

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 240

Inclusion Criteria

Hospitalised

Competent women (≥18 years), able to give informed consent

AF-UTI as presumptive diagnosis and primary reason for hospitalisation*

Adequate intravenous antibiotic therapy for ≥48 - ≤120 hours**

Candidate for safe iv to oral switch as judged by the attending physician

Urine (≥10^4 CFU/ml) OR blood culture: Escherichia coli , ciprofloxacin S AND fosfomycin S***

* Acute Febrile Urinary Tract Infections (AF-UTI) are UTI with at least one of the forthcoming systemic signs or symptoms: fever or low temperature (≥38.0 C ͦ or <36 C ͦ), rigors, delirium, hemodynamic instability as a result of sepsis requiring intravenous fluids, increase in CRP (≥30mg/L) or leucocytes (≥12*109/L) AND at least one of the following local symptoms: lower abdominal pain, low back pain, flank pain or costo-vertebral angle pain or tenderness on physical examination, any of the following symptoms of UTI (dysuria, urinary urgency, urinary frequency, suprapubic/pelvic discomfort, macroscopic hematuria, new urinary incontinence or worsening of pre-existing incontinence). Local symptoms are not required if urine and blood culture yield phenotypically identical E.coli and UTI is the presumed source of infection according to the treating physician. The local study investigator determines the presumptive diagnosis as the primary reason for hospitalization with consultation of the attending physician.
**Amoxicillin+/-clavulanic acid / 2nd or 3rd cephalosporin/ aminoglycoside/ carbapenem/ fluoroquinolones/ trimethoprim-sulfamethoxazole OR a combination AND in vitro susceptibility of the causative E.coli to at least one of the used agents
*** If a participating microbiological laboratory only processes urine cultures ≥ 105 CFU/ml, only these will be included. If an urine or blood culture results in another non-E.coli bacteria that requires antibiotic treatment, the patient should be excluded. A patient is not eligible if non-E.coli-type Enterobacteriaceae are present in urine culture (≥103 CFU/ml) or blood culture.

Exclusion Criteria

Pregnant or nursing women

Glomerular filtration rate < 30 ml/min/1,73 m2 or renal replacement therapy

Concomitant systemic antibacterial treatment for another reason than AF-UTI including concomitant prophylactic antibacterial therapy #

Ascertained or presumptive hypersensitivity to the active compounds and/or any excipient of the products or to any quinole

Participation to any trial with an investigational product involved in the 30 days before the screening visit

Every other laboratory result, clinical condition, disease or treatment that, in investigator’s opinion, make the subject non suitable for the study

Specific comorbidity or diagnosis##

Contraindications/interactions for any of the active compounds or medication ###

Patients with inadequate understanding of the study risks or its requirements or unwilling to plan a follow-up visit

# If prophylactic antibiotic therapy for UTI could not be paused during study therapy, the patient should be excluded

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is the cumulative incidence of survival and clinical cure (resolution of symptoms) 6-10 days post-treatment

Secondary Outcome Measures

Name	Time	Method

Related Trials