Sitafloxacin and Ertapenem Treatment for Acute Pyelonephritis Caused by Escherichia Coli (SETAP)
|ClinicalTrials.gov Identifier: NCT02537847|
Recruitment Status : Unknown
Verified August 2015 by Chitprasong Malaisri, Mahidol University.
Recruitment status was: Recruiting
First Posted : September 2, 2015
Last Update Posted : September 2, 2015
|Condition or disease||Intervention/treatment||Phase|
|Infection Due to Escherichia Coli Acute Pyelonephritis||Drug: Sitafloxacin Drug: Ertapenem||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||96 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Controlled Trial of Sitafloxacin and Ertapenem Treatment for Acute Pyelonephritis Caused by Extended-Spectrum ß-lactamase-producing Escherichia Coli|
|Study Start Date :||November 2012|
|Estimated Primary Completion Date :||September 2015|
|Estimated Study Completion Date :||May 2016|
Experimental: 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.
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.
Other Name: fluoroquinolone
Active Comparator: control group
Intervention was prescribed ertapenem for patients.
Control group will be given ertapenem only for 10 days.
Other Name: carbapenem
- no symptoms of urinary tract infection [ Time Frame: 30 days ]no fever, dysuria, back pain, nausea and vomiting
- no evidence of Extended Spectrum Beta Lactamase Escherichia coli in urine culture [ Time Frame: 30 days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02537847
|Contact: Chitprasong Malaisri, MD||+66 89 466 5043||Mchitprasong@yahoo.com|
|Faculty of Medicine Ramathibodi Hospital||Recruiting|
|Bangkok, Thailand, 10400|
|Contact: Chitprasong Malaisri, MD ++66 89 466 5043 Mchitprasong@yahoo.com|
|Study Director:||Sasisopin Kiertiburanakul||Ramathibodi Hospital Mahidol University|