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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20201027005
Enrollment
110
Registered
2020-10-27
Start date
2021-01-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute cystitis Kidney transplant recipients Cystitis Kidney transplant recipients Fosfomycin trometamol

Interventions

Fosfomycin 3g oral 2 doses every 72 hr ,other antibiotics for 7 days
Experimental Drug,Active Comparator Drug
Fosfomycin trometamol,Conventional antibiotics

Sponsors

Research department, Faculty of Medicine Siriraj Hospital, Mahidol University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Resolution of pyuria 2 weeks after enrollment urinalysis

Secondary

MeasureTime frame
No antibiotic retreatment 3 months after enrollment patients' medical record review

Countries

Thailnad

Contacts

Public ContactPakpoom Phoompoung

Faculty of medicine Siriraj hospital

benefat@hotmail.com0896883653

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026