Sitafloxacin and Ertapenem Treatment for Acute Pyelonephritis Caused by Escherichia Coli

Phase 2

• Conditions: Infection Due to Escherichia Coli; Acute Pyelonephritis
• Interventions: Drug: Ertapenem; Drug: Sitafloxacin

• Registration Number: NCT02537847
• Lead Sponsor: Mahidol University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2012-11
• Status Verified: 2015-08
• Study First Submitted: 2015-08-02
• Study First Submitted QC: 2015-08-28
• Last Update Submitted: 2015-08-28
• Primary Completion: 2015-09
• Study First Posted: 2015-09-02
• Last Update Posted: 2015-09-02
• Study Completion: 2016-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

• Age >18 years
• Acute pyelonephritis by definition
• Positive urine culture for Extended Spectrum Beta Lactamase Escherichia coli ≥105 colony forming unit/mL
• Voluntarily consented to be enrolled in the study

Read More

Exclusion Criteria

• Severe sepsis or septic shock
• Mixed organism of urine culture
• Positive blood culture
• Has other source of infection
• Has mechanical abnormality of urinary tract
• Immunocompromised conditions
• Retained Foley's catheter
• Pregnancy or lactation
• Previous urinary tract infections within 4 weeks
• Contraindicated for fluoroquinolones and carbapenems

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	Ertapenem	Intervention was prescribed ertapenem for patients.
Sitafloxacin group	Sitafloxacin	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.

Primary Outcome Measures

Name	Time	Method
no symptoms of urinary tract infection	30 days	no fever, dysuria, back pain, nausea and vomiting

Secondary Outcome Measures

Name	Time	Method
no evidence of Extended Spectrum Beta Lactamase Escherichia coli in urine culture	30 days

Trial Locations

Locations (1)

Faculty of Medicine Ramathibodi Hospital; 🇹🇭 Bangkok, Thailand