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Oral Fosfomycin after Carbapenems as De-escalating Therapy in Complicated Urinary Tract Infections : A Randomized Control Trial

Oral Fosfomycin after Carbapenems as De-escalating Therapy in Complicated Urinary Tract Infections : A Randomized Control Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250608001
Enrollment
124
Registered
2025-06-08
Start date
2023-08-01
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

Adverse events from medication Adverse events

Interventions

Oral fosfomycin 3 g PO at day 4,6,Ertapenem 1g IV q 24 hr at day 4-7
Experimental Drug,Active Comparator Drug
Fosfomycin oral,Ertapenem

Sponsors

No
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to No maximum

Inclusion criteria

Inclusion criteria: adults aged 20 years or older, diagnosed with cUTIs based on criteria including male gender, females aged more than 51 years, presence of an indwelling catheter, renal stones, urinary obstruction, ureteral stents, recent urological surgery past 6 months, neurogenic bladder, immunosuppressive conditions (patients received chemotherapy or prednisolone at a dose of 30 mg or equivalent, or other immunosuppressive drugs, within the last 30 days), or renal transplantation. Patients must have received appropriate antibiotics for at least 3 days and had urine cultures positive for Enterobacterales (E. coli, Enterobacter spp., Citrobacter spp., Proteus spp.) susceptible to both fosfomycin trometamol and carbapenems

Exclusion criteria

Exclusion criteria: allergy to study drugs, resistance to either drug, urine culture yielded Klebsiella pneumoniae(21), creatinine clearance (CrCl) less than 10 mL/min(22,23), bacteremia, pregnancy, co-infection with other organs, hemodynamic instability, recent participation in other clinical trials, or inability to provide consent without a legal representative.

Design outcomes

Primary

MeasureTime frame
Clinical cure 7 days Clinical assessment

Secondary

MeasureTime frame
microbiological cure 7 days urine culture,clinical cure 28 days clinical assessment,length of stay day Duration of admit,Readmission rate 28 days readmit visit hospital

Countries

Thailand

Contacts

Public ContactKirun Angkanavisan

Phramongkutklao Hospital

vanrunyes10@gmail.com0871393109

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026