Sitafloxacin and Ertapenem Treatment for Acute Pyelonephritis Caused by Escherichia Coli

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Infection Due to Escherichia Coli, Acute Pyelonephritis

Intervention / Treatment
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* Drug: Sitafloxacin
* Drug: Ertapenem


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sitafloxacin group<br>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. | Drug: Sitafloxacin<br>* 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.<br>* Other names: fluoroquinolone;|
| Active Comparator: control group<br>Intervention was prescribed ertapenem for patients. | Drug: Ertapenem<br>* Control group will be given ertapenem only for 10 days.<br>* Other names: carbapenem;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| no symptoms of urinary tract infection | no fever, dysuria, back pain, nausea and vomiting | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| no evidence of Extended Spectrum Beta Lactamase Escherichia coli in urine culture |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sitafloxacin, Extended-Spectrum ß-lactamase-producing Escherichia coli, Treatment for Acute Pyelonephritis, Ertapenem