Health Condition 1: N390- Urinary tract infection, site notspecified
Conditions
Interventions
Intervention1: Piperacillin-tazobactam: Patients diagnosed with ceftriaxone resistance acute pyelonephritis will be randomised and given iv Piperacillin-tazobactam
Intervention2: Piperacillin-tazobact
Sponsors
All India Institute of Medical Sciences, Jodhpur
Eligibility
Inclusion criteria
Inclusion criteria: The study will include all hospitalized adults (aged 18 years or greater) with clinically diagnosed pyelonephritis and isolation of E. coli, Klebsiella, or Proteus species from at least one urine culture that shows resistance to ceftriaxone and susceptibility to both piperacillin-tazobactam and meropenem. The diagnosis of pyelonephritis will be based on clinical and microbiological findings, acute fever, flank pain, and urinary symptoms with equal or more than 10 pus cells per high-power field (hpf) in urine, with or without radiological evidence from abdominal ultrasound or CT scan.
Exclusion criteria
Exclusion criteria: Acute pyelonephritis with septic shock or immunocompromised patients Emphysematous Pyelonephritis Renal abscess Other complicated UTIs where source control could not be achieved due to various reasons Pregnancy Not expect to survive beyond 96 hours Conditions or co-infections where antibiotics needs to be given other than trial drugs Receipt of antibiotics other than trial drugs within 7 days of randomisation End stage renal disease with eGFR less than 30 ml/min/1.73 m2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is a composite measure of: Clinical failure: Persistence of fever (more than 38 C) and leukocytosis (WBC more than 12 10^9/L) on days 3 to 5 post-randomization Microbiological failure: Presence of the same organism in urine culture on days 3 to 5 post-randomization Microbiological relapse: Growth of the index microorganism from the completion of therapy up to day 30 post-randomization. Timepoint: Days 3-5 post-randomization for clinical and microbiological failure; from end of therapy up to Day 30 post-randomization for microbiological relapse | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcomes of the study are as follows: A. All-cause mortality at day 30 (days since randomization) in both groups (piperacillin-tazobactam & meropenem). B. Change of initial antibiotic regimen or escalation of antibiotics. C. Emergence of resistance to the treating antibiotic regimen during the treatment period or within 30 days post-randomization. D. Distribution & correlation of different ESBL genes with outcomes in patients treated with piperacillin-tazobactam & meropenem. E. Length of hospital stay & ICU stay. F. Need for vasopressor support or occurrence of septic shock. G. Detection of carbapenemase & ESBL genes in ceftriaxone-resistant isolates. Timepoint: During index hospitalization & at Day 30 post-randomization (mortality, escalation, resistance, vasopressors, septic shock, LOS); baseline culture at enrollment for ESBL/carbapenemase genes; correlation of ESBL genes with outcomes at Day 30 | — |
Countries
India
Contacts
Public ContactDurga Shankar Meena
AIIMS Jodhpur
Outcome results
None listed