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Sitafloxacin vs Ertapenem for ESBL UTI in Kidney Transplant
NCT02729116Phase 3
Key facts
- Status
- Unknown
- Start
- Jul 2016
- Primary completion
- Dec 2023
- Countries
- 1
- Sponsor
- Khon Kaen University
- Modality
- Small Molecules
- Drugs
- sitafloxacin
- Conditions
- urinary tract infection (UTI)
01
Overview
Phase 3, randomised, open-label trial of sitafloxacin in urinary tract infection (UTI) (2 arms), sponsored by Khon Kaen University. Primary endpoint: Number of patients with clinical cure of acute urinary tract infection at 14 days. Status: unknown.
02
Design
2 arms- Study design
- RandomizedOpen-label
Sitafloxacin group
Sitafloxacin 100 mg oral twice daily
Ertapenem group
Ertapenem 1 gm IV every 24 h
03
Who it enrols
Adult post-kidney transplantation patients with acute urinary tract infection caused by ESBL-producing E. coli or K. pneumoniae.
04
Endpoints
Primary
Number of patients with clinical cure of acute urinary tract infection
Secondary
Number of patients with micrological cure of acute urinary tract infection
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