Clinical response at the end of treatment of acute pyelonephritis with pre-specified antibiotic duration Pyelonephritis Ceftriaxone resistant Shorter antibiotic regimen
Conditions
Interventions
7-day course of carbapenem for treatment of acute pyelonephritis caused by ceftriaxone-resistant E. coli or K. pneumoniae,Contemporary 14-day course of carbapenem for treatment of acute pyelonephritis
Experimental Drug,Active Comparator Drug
Shorter regimen (7 days),Longer regimen (14 days)
Sponsors
Faculty of Medicine, CHIANG MAI University
Eligibility
Sex/Gender
Female
Age
20 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Female of age 20 years and above 2. Can provide written informed consent 3. Fulfill diagnostic criteria of acute pyelonephritis consisting of all of the following: 3.1 Urinalysis shows either 10 or more WBC per HPF, or 1+ or higher concentration of leukocyte esterase 3.2 Having at least one of the following symptoms signifying upper urinary tract infection: 3.2.1 Fever > 38.0 degree Celcius 3.2.2 Chills 3.2.3 Nausea or vomitus 3.2.4 Flank pain or costo-vertebral angle tenderness 3.3 Urine culture with > 10,000 CFU/ml of single organism 4. Urine culture yield either Escherichia coli or Klebsiella pneumoniae with MIC > 2 mcg/ml, consistent with criteria of ceftriaxone resistance 5. If the patient is catheterized with urinary catheter, the prior indwelling time cannot exceed 14 days before randomization. The catheter is to be removed if it is no longer indicated.
Exclusion criteria
Exclusion criteria: 1. The duration of antibiotics used exceed or fall short of the pre-randomized duration 2. Pregnancy 3. Immunocompromised status: 3.1 HIV-infected with CD4 < 200 cells/cu.mm 3.2 Allogenic stem cells transplant (ASCT) or solid organ transplant 3.3 Neutropenia, defined as absolute neutrophils < 500 cells/cu.mm at the point of randomization 4. Clinical instability within 48 hours before randomization, including patients with mean arterial pressure lower than 65 mmHg needing inotropic agents despite adequate volume resuscitation 5. Concurrent infection at other sites 6. Urinary tract infection complicated by conditions that require surgical intervention such as undrained renal abscess, urinary tract obstruction, or emphysematous pyelonephritis 7. Invasive urinary devices such as PCNs 8. Estimated glomerular filtration rate of less than 15 mL/min/1.73m2 or requiring renal replacement therapy 9. Renal system's structural abnormalities such as horseshoe kidney, polycystic kidney disease, renal or ureteral calculi, or vesicoureteral reflux 10. Known or suspected allergy from carbapenem antibiotics 11. Deny participation 12. Patient in advanced care plan with less than 24 hours of life expectancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical cure End of antibiotic regimen Resolution of presenting symptoms | — |
Secondary
| Measure | Time frame |
|---|---|
| Microbiological cure 14 days after end of antibiotic course Urine culture,Clinical recurrence Within 30 days of symptom onset Phone call to ask for new symptoms,Adverse effect during treatment course Throughout enrollment period Observation | — |
Countries
Thailand
Contacts
Public ContactJetanat Chantrapitak
CMU
Outcome results
None listed