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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02537847
Other study ID # Sitafloxacin123
Secondary ID
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


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
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