Fosfomycin as stepdown treatment for ascending urinary tract infections

Phase 1

• Conditions: Acute febrile urinary tract infection; MedDRA version: 20.0Level: LLTClassification code 10046574Term: Urinary tract infection NOSSystem Organ Class: 100000017512; MedDRA version: 20.0Level: LLTClassification code 10046576Term: Urinary tract infection, site not specifiedSystem Organ Class: 100000017512; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2016-004486-37-NL
• Lead Sponsor: niversity Medical Centre Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-14
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

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 (=104 CFU/ml) OR blood culture obtained within 24 hours before or after admission: Escherichia coli , ciprofloxacin S AND fosfomycin S***

* Acute Febrile Urinary Tract Infections (AF-UTI) are UTI with at least one of the forthcoming systemic symptoms: fever or low temperature (=38.0 C ? or <36 C ?), rigors, delirium or hemodynamic instability as a result of sepsis requiring intravenous fluids 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). The local study investigator determines the presumptive diagnosis as the primary reason for hospitalisation 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.

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 140
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

-Pregnant or nursing women
-Glomerular filtration rate < 30 ml/min/1,73 m3 or renal replacement therapy
-Concomitant systemic antibacterial treatment #
-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 could not be paused during study therapy, the patient should be excluded Except for continuation of prophylactic antibacterial therapy
## Renal transplant patients, polycystic kidney disease, neutropenia (<500 /µl), paraplegia, long-term indwelling catheters (placed =24 hours before admission), urostomy, ileal loops, double-J catheter, nephrostomy catheter, suprapubic catheter, suspicion/presence of renal abscess, suspicion of septic metastatic foci/endocarditis
### Concurrent use of Tizanidin, Clozapin or Theophylline. If pausing or conversion of this medicine disadvantages the participant, she will be excluded. Patients with a history of tendon disease/disorder related to quinolone treatment. Patients with known risk factors for prolongation of the QT interval. Glucose-6-phosphate dehydrogenase deficiency

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified