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Sitafloxacin and Ertapenem Treatment for Acute Pyelonephritis Caused by Escherichia Coli (SETAP)

Primary Purpose

Infection Due to Escherichia Coli, Acute Pyelonephritis

Status
Unknown status
Phase
Phase 2
Locations
Thailand
Study Type
Interventional
Intervention
Sitafloxacin
Ertapenem
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infection Due to Escherichia Coli focused on measuring Sitafloxacin, Extended-Spectrum ß-lactamase-producing Escherichia coli, Treatment for Acute Pyelonephritis, Ertapenem

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of Medicine Ramathibodi HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sitafloxacin group

control group

Arm Description

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.

Intervention was prescribed ertapenem for patients.

Outcomes

Primary Outcome Measures

no symptoms of urinary tract infection
no fever, dysuria, back pain, nausea and vomiting

Secondary Outcome Measures

no evidence of Extended Spectrum Beta Lactamase Escherichia coli in urine culture

Full Information

First Posted
August 2, 2015
Last Updated
August 28, 2015
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT02537847
Brief Title
Sitafloxacin and Ertapenem Treatment for Acute Pyelonephritis Caused by Escherichia Coli
Acronym
SETAP
Official Title
A Randomized Controlled Trial of Sitafloxacin and Ertapenem Treatment for Acute Pyelonephritis Caused by Extended-Spectrum ß-lactamase-producing Escherichia Coli
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 2012 (undefined)
Primary Completion Date
September 2015 (Anticipated)
Study Completion Date
May 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection Due to Escherichia Coli, Acute Pyelonephritis
Keywords
Sitafloxacin, Extended-Spectrum ß-lactamase-producing Escherichia coli, Treatment for Acute Pyelonephritis, Ertapenem

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sitafloxacin group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
Active Comparator
Arm Description
Intervention was prescribed ertapenem for patients.
Intervention Type
Drug
Intervention Name(s)
Sitafloxacin
Other Intervention Name(s)
fluoroquinolone
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ertapenem
Other Intervention Name(s)
carbapenem
Intervention Description
Control group will be given ertapenem only for 10 days.
Primary Outcome Measure Information:
Title
no symptoms of urinary tract infection
Description
no fever, dysuria, back pain, nausea and vomiting
Time Frame
30 days
Secondary Outcome Measure Information:
Title
no evidence of Extended Spectrum Beta Lactamase Escherichia coli in urine culture
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chitprasong Malaisri, MD
Phone
+66 89 466 5043
Email
Mchitprasong@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sasisopin Kiertiburanakul
Organizational Affiliation
Ramathibodi Hospital Mahidol University
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Medicine Ramathibodi Hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chitprasong Malaisri, MD
Phone
++66 89 466 5043
Email
Mchitprasong@yahoo.com

12. IPD Sharing Statement

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Sitafloxacin and Ertapenem Treatment for Acute Pyelonephritis Caused by Escherichia Coli

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