A Phase 2 interventional study of Sitafloxacin and Ertapenem in Infection Due to Escherichia Coli and Acute Pyelonephritis, sponsored by Mahidol University. Status unknown at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-09-02.
Sponsored by Mahidol University · Phase 2, Interventional, and Treatment
The aim of the investigators' study was to evaluate oral and non carbapenem antimicrobial agents which can be used in outpatient for the treatment of non-bacteremic acute pyelonephritis caused by Extended Spectrum Beta Lactamase Escherichia coli. This study was conducted to compare the clinical and bacteriological outcomes of patients with non-bacteremic acute pyelonephritis caused by Extended Spectrum Beta Lactamase Escherichia coli who were treated with intravenous (IV) carbapenems followed by oral sitafloxacin or IV ertapenem.
A prospective randomized controlled trial of patients with a presumptive diagnosis of acute pyelonephritis caused by Extended Spectrum Beta Lactamase-producing pathogen was performed. Carbapenems was initially given to all patients. After day 3, patients were randomized to receive either oral sitafloxacin (100 mg twice daily) or intravenous ertapenem. The regular course of treatment was completed within 10 days.
96 studies on the registry are indexed under Escherichia coli Infections; 17 are open to participants now.
This study's planned enrollment of 96 is close to the median of 90 across 58 interventional studies indexed under Escherichia coli Infections.
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Exclusion Criteria:
The first third days of treatment was open label and all patients were given intravenous carbapenems. After day 3, the patients were randomized to either sitafloxacin group or ertapenem group by the use of a computer-generated random number allocation schedule and block size of four. The patients were allocated to the sitafloxacin group or ertapenem group using the sealed envelope method.
Drug: Sitafloxacin
Intervention was prescribed ertapenem for patients.
Drug: Ertapenem
The patients in intervention group will receive carbapenem for the first 3 days then sitafloxacin for 7 days. Total of treatment duration is 10 days.
Also known as: fluoroquinolone
Control group will be given ertapenem only for 10 days.
Also known as: carbapenem
no symptoms of urinary tract infection
no fever, dysuria, back pain, nausea and vomiting
Time frame: 30 days
no evidence of Extended Spectrum Beta Lactamase Escherichia coli in urine culture
Time frame: 30 days
This study is status unknown, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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Mahidol University