CTRI Number |
CTRI/2016/04/006810 [Registered on: 08/04/2016] Trial Registered Retrospectively |
Last Modified On: |
03/12/2019 |
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
|
|
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
|
|
Health Condition / Problems Studied
Modification(s)
|
Health Type |
Condition |
Patients |
Acute pyelonephritis |
Patients |
Urinary tract infection, site notspecified |
|
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
Modification(s)
|
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. |