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Efficacy of oral fosfomycin as a step down therapy after treatment for upper urinary tract infection caused by extended-spectrum b-lactamase-producing Escherichia coli

Efficacy of oral fosfomycin as a step down therapy after treatment for upper urinary tract infection caused by extended-spectrum b-lactamase-producing Escherichia coli

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20171021001
Enrollment
140
Registered
2017-10-21
Start date
2018-03-19
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

Upper urinary tract infection ESBL&#45

Interventions

Give 2 doses of 3 g oral fosfomycin sachet with 72 hr interval,Give IV ertapenem (renal dose adjustment) for 7&#45
10 day
Experimental Drug,Active Comparator Drug
Oral Fosfomycin,Ertapenem

Sponsors

Research department, Faculty of Medicine Siriraj Hospital, Mahidol University
Lead Sponsor
Zambon pharmaceutical company
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Admitted patient who was diagnosed as complicaed or non-complicated upper urinary tract infection in Siriraj hospital 2. Urine culture grow 105 E.coli resisting to third generation cephalosporins and susceptible to fosfomycin (CLSI criteria)

Exclusion criteria

Exclusion criteria: 1. Positive hemoculture 2. Multiple organ infection 3. Mixed urine culture 4. Pregnant or breast feedind woman 5. History of fosfomycin allergy 6. Chronic kidney disease (eGFRB less than 30 mL/min/1.73m2) 7. GI malabsorption 8. Receive proper IV antibiotics more than 7 days before enrollment

Design outcomes

Primary

MeasureTime frame
clinical cure rate 14 day clinical examation

Secondary

MeasureTime frame
Microbiological cure rate 14 and 30 day Urine culture

Countries

Thailand

Contacts

Public ContactWantin Sribenjalux

Siriral hospital

wantin.sri@mahidol.ac.th085-854-6585

Outcome results

None listed

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