Efficacy of oral fosfomycin trometamol for empirical treatment of acute cystitis in kidney transplant recipient: an open label randomized controlled trial

Phase 3

• Conditions: Acute cystitis Kidney transplant recipients; Cystitis; Kidney transplant recipients; Fosfomycin trometamol

• Registration Number: TCTR20201027005
• Lead Sponsor: Research department, Faculty of Medicine Siriraj Hospital, Mahidol University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-27
• Study Completion: 2022-12-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

Kidney transplant recipients age ≥ 18 years
Suspected acute cystitis
-Pyuria; urine WBC ≥ 5 cells/HPF
-Bacteriuria; any bacteria found
-Necessitate antibiotic treatment by primary physicians

Exclusion Criteria

Patients with sign or symptoms of upper urinary tract infection or acute pyelonephritis (fever, nausea and vomiting, flank pain, kidney graft tenderness)
History of Fosfomycin trometamol allergy
kidney function creatinine clearance below 10 ml/min
patients with primary graft failure required continuous renal replacement therapy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Resolution of pyuria 2 weeks after enrollment urinalysis

Secondary Outcome Measures

Name	Time	Method
o antibiotic retreatment 3 months after enrollment patients' medical record review