Sitafloxacin and Ertapenem Treatment for Acute Pyelonephritis Caused by Escherichia Coli
NCT ID: NCT02537847
Last Updated: 2015-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
96 participants
INTERVENTIONAL
2012-11-30
2016-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Sitafloxacin group
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.
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.
control group
Intervention was prescribed ertapenem for patients.
Ertapenem
Control group will be given ertapenem only for 10 days.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Mahidol University
OTHER
Responsible Party
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Chitprasong Malaisri
Ramathibodi Hospital
Principal Investigators
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Sasisopin Kiertiburanakul
Role: STUDY_DIRECTOR
Ramathibodi Hospital Mahidol University
Locations
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Faculty of Medicine Ramathibodi Hospital
Bangkok, Bangkok, Thailand
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Sitafloxacin123
Identifier Type: -
Identifier Source: org_study_id
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