Sitafloxacin and Ertapenem Treatment for Acute Pyelonephritis Caused by Escherichia Coli

Acute Pyelonephritis Clinical Trial

— SETAP  

Official title:

A Randomized Controlled Trial of Sitafloxacin and Ertapenem Treatment for Acute Pyelonephritis Caused by Extended-Spectrum ß-lactamase-producing Escherichia Coli

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02537847
• Other study ID #: Sitafloxacin123
• Status: Recruiting
• Phase: Phase 2
• First received: August 2, 2015
• Last updated: August 28, 2015
• Start date: November 2012
• Est. completion date: May 2016

Study information

• Verified date: August 2015
• Source: Mahidol University
• Contact: Chitprasong Malaisri, MD
• Phone: +66 89 466 5043
• Email: Mchitprasong[@]yahoo.com
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: May 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Pyelonephritis
• Escherichia coli Infections
• Infection Due to Escherichia Coli
• Pyelonephritis

Intervention

Drug:
• Sitafloxacin
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.
• Ertapenem
Control group will be given ertapenem only for 10 days.

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Ramathibodi Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	no symptoms of urinary tract infection	no fever, dysuria, back pain, nausea and vomiting	30 days	Yes
Secondary	no evidence of Extended Spectrum Beta Lactamase Escherichia coli in urine culture		30 days	Yes