Sitafloxacin and Ertapenem Treatment for Acute Pyelonephritis Caused by Escherichia Coli

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02537847

Acronym

SETAP

Enrollment

Registered

2015-09-02

Start date

2012-11-30

Completion date

2016-05-31

Last updated

2015-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection Due to Escherichia Coli, Acute Pyelonephritis

Keywords

Sitafloxacin, Extended-Spectrum ß-lactamase-producing Escherichia coli, Treatment for Acute Pyelonephritis, Ertapenem

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.

Interventions

DRUGSitafloxacin

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.

DRUGErtapenem

Control group will be given ertapenem only for 10 days.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
no symptoms of urinary tract infection	30 days	no fever, dysuria, back pain, nausea and vomiting

Secondary

Measure	Time frame
no evidence of Extended Spectrum Beta Lactamase Escherichia coli in urine culture	30 days

Countries

Thailand

Contacts

Primary ContactChitprasong Malaisri, MD

Mchitprasong@yahoo.com+66 89 466 5043

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026