FULL DETAILS (Read-only)

CTRI Number  CTRI/2016/04/006810 [Registered on: 08/04/2016] Trial Registered Retrospectively
Last Modified On: 09/07/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study
Modification(s)  
Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of 7 days versus 14 days antibiotics for patients hospitalized with non-severe kidney infection 
Scientific Title of Study   Comparison of 7 days versus 14 days antibacterial treatment for hospitalized non-severe acute pyelonephritis patients-a randomized controlled trial 
Secondary IDs if Any  
Secondary ID  Registry 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Deepanjali S 
Address  Department of Medicine Jawaharlal Institute of postgraduate Medical Education and Research
D-II/14, Staff Quarters JIPMER, Puducherry
Pondicherry
PONDICHERRY
605006
India 
Phone  9488819981  
Fax    
Email  deepanjali.s@jipmer.edu.in  
 
Details Contact Person
Scientific Query

Modification(s)  
Name  Pavan Kumar Rudrabhatla 
Address  Department of Medicine Jawaharlal Institute of postgraduate Medical Education and Research
Room No.513, Harvey house-II, New hostel complex, JIPMER, Puducherry
Pondicherry
PONDICHERRY
605006
India 
Phone  9159525608  
Fax    
Email  pavankumarrudrabhatla@gmail.com  
 
Details Contact Person
Public Query
 
Name  Deepanjali S 
Address  Department of Medicine Jawaharlal Institute of postgraduate Medical Education and Research
D-II/14, Staff Quarters JIPMER, Puducherry
Pondicherry
PONDICHERRY
605006
India 
Phone  9488819981  
Fax    
Email  deepanjali.s@jipmer.edu.in  
 
Source of Monetary or Material Support
Modification(s)  
Department of medicine, Jawaharlal Institute of Postgraduate Medical Education and research, Puducherry, 605006 
 
Primary Sponsor
Modification(s)  
Name  Department of Medicine Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Dhanvantri Nagar Puducherry, 605006 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 1  
Contact Person  Name of Site  Site Address  Phone/Fax/Email 
DrDeepanajli S  Jawaharlal Institute of Postgraduate Medical Education and Research  Room no.4056, Medicine office, Third floor,Old block, ,JIPMER
Pondicherry
 
9488819981

deepanjalis@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Acute pyelonephritis 
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Comparator Agent  14 days antibacterial treatment  In the comparator arm, patients admitted with acute pyelonephritis are given a total of 14 days of sensitive antibiotic/antibiotics 
Intervention  7 days antibacterial treatment  In the intervention arm, patients admitted with acute pyelonephritis are given a total of 7 days of sensitive antibiotic/antibiotics. The choice of the antibiotic/antibiotics is made by the treating physician either as empirical therapy or later modified as culture guided therapy 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Either sex aged >18 years, admitted for acute pyelonephritis, defined as fever of at least 38oC and at least one symptom or sign relating to the urinary tract such as flank pain, costovertebral angle tenderness, dysuria, urgency or frequency along with the microbiologic criteria (≥10 pus cells/hpf or dipstick leucocyte esterase test positive and a positive culture with ≥10 5 CFU/ mL of urine). They should have improved with empirical or culture-guided antibiotic treatment and be afebrile for at least 48 hours by day 7 of antibiotic treatment. 
 
ExclusionCriteria 
Details  •Catheter-associated UTI
•Recurrent UTI
•Obstructive uropathy
•Residual bladder urine >100 ml
•Acute or chronic prostatitis / prostatic abscess
• Emphysematous PN/renal or perinephric abscess
•Shock requiring vasopressors
•Altered sensorium requiring intubation (GCS score <8)
•Acute lung injury requiring mechanical ventilation
•Renal failure requiring RRT
•Clinically manifest DIC
•Pregnancy
•Any immunosuppressive treatment
 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Re-treatment rates within 6 weeks (Due to clinical or microbiological failure)
 
Re-treatment rates within 6 weeks (Due to clinical or microbiological failure)
 
 
Secondary Outcome  
Outcome  TimePoints 
1.Duration of hospital stay
2.Daily defined dose of antibiotics
3.Asymptomatic bacteriuria
4.Adverse affects of antibiotics
 
1. At the time of discharge
2.During the hospital stay
3. At 6 weeks
4. During the hospital stay 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   17/03/2015 
Date of First Enrollment (Global)  No Date Specified 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None 
Brief Summary   The hypothesis of the study is that antibacterial treatment with sensitive antibacterial/antibacterials for 7 days is non-inferior to treatment for 14 days in patients with non-severe acute pyelonephritis. If this is proven, then the duration of hospitalization, side effects of antibiotics as well as development of antibiotic resistance can be reduced. 

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