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CTRI Number  CTRI/2025/12/098770 [Registered on: 10/12/2025] Trial Registered Prospectively
Last Modified On: 09/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A trial to compare two antibiotic treatments for kidney infection resistant to ceftriaxone 
Scientific Title of Study   Piperacillin-tazobactam versus Carbapenem in Ceftriaxone resistant Community-acquired Acute Pyelonephritis: A Non-inferior Open Labelled Randomised Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Durga Shankar Meena 
Designation  Associate Professor 
Affiliation  AIIMS Jodhpur 
Address  Room No: 120, Medicine OPD Block, AIIMS Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  9772200453  
Fax    
Email  meenads@aiimsjodhpur.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Durga Shankar Meena 
Designation  Associate Professor 
Affiliation  AIIMS Jodhpur 
Address  Room No: 120, Medicine OPD Block, AIIMS Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  9772200453  
Fax    
Email  meenads@aiimsjodhpur.edu.in  
 
Details of Contact Person
Public Query  
Name  Durga Shankar Meena 
Designation  Associate Professor 
Affiliation  AIIMS Jodhpur 
Address  Room No: 120, Medicine OPD Block, AIIMS Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  9772200453  
Fax    
Email  meenads@aiimsjodhpur.edu.in  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Jodhpur, Rajasthan, India (342005) 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences, Jodhpur 
Address  AIIMS Jodhpur, Basni, Jodhpur, 342005; Rajasthan 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Durga Shankar Meena  All India Institute of Medical Sciences, Jodhpur  Room No:120, Department of General Medicine (Division of Infectious Diseases)
Jodhpur
RAJASTHAN 		 9772200453

meenads@aiimsjodhpur.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (Clinical Trial), AIIMS Jodhpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N390||Urinary tract infection, site notspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Meropenem Dose: 1 gm Mode: Intravenous Frequency: every 8 hourly Duration: 14 days  In other arm, patient will receive iv meropenem which will the comparator arm Dose will be modified based on renal function if required 
Intervention  Piperacillin-tazobactam Dose: 4.5 gm Frequency: every 6 hourly Mode: intravenous Total duration: 14 days  Patients diagnosed with ceftriaxone resistant acute pyelonephritis will be randomised and given iv piperacillin-tazobactam Dose will be adjusted based on renal function if required 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  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. 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
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.
 		 Days 3-5 post-randomization for clinical and microbiological failure; from end of therapy up to Day 30 post-randomization for microbiological relapse 
 
Secondary Outcome  
Outcome  TimePoints 
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.
 		 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 
 
Target Sample Size   Total Sample Size="238"
Sample Size from India="238" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   22/12/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

This will be an open labelled non-inferiority randomised controlled trial to demonstrate the non-inferiority of piperacillin-tazobactam for the treatment of acute pyelonephritis caused by ceftriaxone resistant Enterobacteriaceae. The study will be conducted at AIIMS Jodhpur, department of General Medicine after the duly approval from institutional ethical committee and registration in clinical trial registry-India (CTRI). The PICOT of this will be following:

 

 Population: All patient with age equal or more than 18 years, diagnosed with acute pyelonephritis (clinico-radiological and microbiological) and urine culture showing isolation of ceftriaxone resistant Enterobacteriaceae.

 Intervention: Patient will receive piperacillin-tazobactam 4.5 gm intravenous 6 hourly

 Comparison: With Meropenem (Carbapenem)

 Outcome: Clinical and microbiological failure

 Time: Approximately 2 years since inception of study (Ethical approval and first  recruitment)

 

The research question will examine the clinical and microbiological efficacy of piperacillin-tazobactam for treating acute pyelonephritis caused by ESBL-producing, ceftriaxone-resistant isolates. The study aims to assess the effectiveness of piperacillin-tazobactam in treating ceftriaxone-resistant (ESBL-producing Enterobacteriaceae) acute pyelonephritis and to compare its efficacy with standard carbapenem therapy. The primary outcome will be a composite measure of clinical failure (persistent fever more than 38 degree celsius and leukocytosis, WBC more than 12,000 from day 3 to 5 post-randomization), microbiological failure (presence of the index organism in urine culture at day 3-5 post-randomization), and microbiological relapse (reappearance of the index microorganism any time from completion of therapy to day 30 post-randomization). Secondary outcomes will include all-cause mortality at 30 days post-randomization in both groups (piperacillin-tazobactam and meropenem), as well as the following additional measures: a) change in initial antibiotic regimen/escalation of antibiotics, b) emergence of resistance to the treatment regimen during therapy or within 30 days post-randomization, c) detection of carbapenemase and ESBL-producing genes in ceftriaxone-resistant isolates, d) length of hospital/ICU stay, e) need for vasopressor support or occurrence of septic shock, and f) distribution and correlation of various ESBL genes with outcomes in patients treated with piperacillin-tazobactam and meropenem.

This study will include all hospitalized adults (aged 18 years or more) diagnosed with acute pyelonephritis, who have an isolated culture of E. coli, Klebsiella, or Proteus species from at least one urine sample, showing resistance to ceftriaxone but susceptibility to both piperacillin-tazobactam and meropenem. Exclusion criteria include patients with septic shock, those receiving end-of-life care, as well as individuals with emphysematous pyelonephritis, renal abscesses, end-stage renal disease, or disseminated infections. The primary objective of this study is to establish that piperacillin-tazobactam is non-inferior to meropenem in the treatment of acute pyelonephritis caused by ceftriaxone-resistant Enterobacteriaceae.

 
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