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

Mahidol University

Status and phase: Unknown; Phase 2

Conditions: Infection Due to Escherichia Coli; Acute Pyelonephritis

Treatments: Drug: Sitafloxacin; Drug: Ertapenem

Study type: Interventional

Funder types: Other

Identifiers

NCT02537847

Sitafloxacin123

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

96 participants in 2 patient groups

Sitafloxacin group

Experimental group

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.

Treatment:

Drug: Sitafloxacin

control group

Active Comparator group

Description:

Intervention was prescribed ertapenem for patients.

Treatment:

Drug: Ertapenem