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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sitafloxacin group | Experimental | 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. |
|
| control group | Active Comparator | Intervention was prescribed ertapenem for patients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sitafloxacin | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| no symptoms of urinary tract infection | no fever, dysuria, back pain, nausea and vomiting | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| no evidence of Extended Spectrum Beta Lactamase Escherichia coli in urine culture | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chitprasong Malaisri, MD | Contact | +66 89 466 5043 | Mchitprasong@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Sasisopin Kiertiburanakul | Ramathibodi Hospital Mahidol University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine Ramathibodi Hospital | Recruiting | Bangkok | Bangkok | 10400 | Thailand |
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| ID | Term |
|---|---|
| D004927 | Escherichia coli Infections |
| ID | Term |
|---|---|
| D004756 | Enterobacteriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| C076246 | sitafloxacin |
| D024841 | Fluoroquinolones |
| D000077727 | Ertapenem |
| D015780 | Carbapenems |
| ID | Term |
|---|---|
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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|
| Ertapenem | Drug | Control group will be given ertapenem only for 10 days. |
|
|
| D007239 | Infections |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |