A Randomized, Controlled Trial of Prulifloxacin as Switched Therapy after Intravenous Carbapenem in The Treatment of Acute Pyelonephritis Caused by Third Generation Cephalosporin Resistant Pathogens: A Pilot study
- Conditions
- Patients with acute pyelonephritis caused by third generation cephalosporin resistant pathogens with or without bacteremia/sepsisprulifloxacin, ertapenem, pyelonephritis, extended-spectrum beta lactamase
- Registration Number
- TCTR20181202002
- Lead Sponsor
- THAI MEIJI PHARMACEUTICAL CO., LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Terminated
- Sex
- All
- Target Recruitment
- 30
1.aged older than 18 years
2.Urine culture show 10,000 CFU/ml of third generation cephalosporin resistant pathogens. Causative bacteria are classified into susceptibility to ertapenem and prulifloxacin.
3.signs and symptoms are not worsening after receiving empirical therapy.
1. Pregnancy and lactation
2. History allergy to beta lactams or fluoroquinolones
3. Treatment with antiretroviral drugs, immunosuppressive drugs or corticosteroids
4. Need more than one antibiotic for treatment.
5. Complete obstruction of the urinary tract need to surgery.
6. Serious diseases lead to shorten lifespan no more than 72 hours.
7. Neutropenia (Absolute neutrophil counts less than 500 cell/microliters)
8. Creatinine clearance less than 20 ml/min
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall clinical success (clinical cure and clinical improvement) 1-7 day post treatment (any day) Complete blood count, urine analysis, urine culture, signs and symptoms
- Secondary Outcome Measures
Name Time Method Microbiological cure 1-7 day post treatment (any day) urine culture,Recurrent infection 14-30 day post treatment (any day) Complete blood count, urine analysis, urine culture, signs and symptoms