| CTRI Number |
CTRI/2017/09/009721 [Registered on: 12/09/2017] Trial Registered Retrospectively |
| Last Modified On: |
24/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing one day of intravenous Amikacin to 3 days in preventing urinary infection in patients undergoing transurethral resection of the Prostate |
|
Scientific Title of Study
|
Prospective, Randomized, Comparative Study on the Efficacy of one day versus 3 days of intravenous Amikacin(15mg/Kg) as prophylaxis in patients undergoing transurethral resection of the Prostate |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Selvin Theodore Jayanth E |
| Designation |
Mch registrar |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Dept. of Urology Unit - 1
Christian Medical College, Vellore,
22,C-7 Shanthi Illam, CMC hospital Campus, Vellore - 632004
Vellore
TAMIL NADU
632004
India |
| Phone |
9487608992 |
| Fax |
|
| Email |
stjayanth2704@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Chandrasingh |
| Designation |
Professor |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Dept. of Urology Unit - 1
Christian Medical College, Vellore,
Vellore
TAMIL NADU
632004
India |
| Phone |
9442609368 |
| Fax |
|
| Email |
chandrasingh@cmcvellore.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Selvin Theodore Jayanth E |
| Designation |
Sr. PG registrar, MCh Urology, 1st year |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Urology Unit-1
Christian Medical College and Hospital, Vellore,
Vellore
TAMIL NADU
632004
India |
| Phone |
9487608992 |
| Fax |
|
| Email |
stjayanth2704@gmail.com |
|
|
Source of Monetary or Material Support
|
| Fluid research fund, Christian medical College, Vellore |
|
|
Primary Sponsor
|
| Name |
Fluid research fund CMC Vellore |
| Address |
Christian Medical college, Vellore, 632004 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Selvin Theodore Jayanth E |
Christian Medical college,Vellore |
Dept of Urology,No: 203,2nd floor OPD building,Christian Medical college, Vellore,Tamil Nadu, 632004
Vellore
TAMIL NADU |
9487608992
stjayanth2704@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review board(silver, Reasearch and ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Bladder outlet obstruction due to benign prostatic enlargement, (1) ICD-10 Condition: N390||Urinary tract infection, site notspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
1 day versus 3 days of inj. Amikacin in urine culture negative patients undergoing TURP.
|
first arm will receive 1 dose of Inj. Amikacin 15g/Kg at induction and the Second arm will receive 3 days of inj. Amikacin 15 mg/Kg in urine culture negative patients undergoing TURP.
Begining from 1 hour prior to induction and continuing for 2 days postoperaively till urinary catheter removal |
| Intervention |
Inj. AMIKACIN as prophylaxis IN URINE CULTURE NEGATIVE PATIENTS UNDERGOING TURP |
Inj.Amikacin 15 mg/Kg as prophylaxis in patients undergoing TURP |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Male |
| Details |
Patients undergoing TURP who have sterile preoperative urine culture (patients without bacteriuria preoperatively - cfu < 104/ml) |
|
| ExclusionCriteria |
| Details |
1.Patients on a catheter(SPC/perurethral)
2.Preoperative urine culture positivity.
3.Patients who have received antibiotics in the past 1 week.
4.Any contraindication to aminoglycoside
5. Patients who require prolonged catheterization or who develop AUR(acute urinary retention) and need re-catheterisation/ Bladder wash and Re-operation due to hematuria.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the rate of bacteriuria (CFU 104/ml) 4 days after TUR-P |
4 days after TUR-P |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a. Incidence of postoperative symptomatic UTI and other complications.
b. To assess the risk factors for developing complications
UTI, Sepsis, Hemorrhage
|
At 1 week and 4 weeks follow up |
|
|
Target Sample Size
|
Total Sample Size="334"
Sample Size from India="334"
Final Enrollment numbers achieved (Total)= "338"
Final Enrollment numbers achieved (India)="338" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2016 |
| Date of Study Completion (India) |
04/04/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
06/05/2019 |
|
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
Modification(s)
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In urological practice transurethral resection of prostate (TURP) is the most commonly performed operation. The aim of antibiotic prophylaxis is to reduce the bacteriuria rate and thereby reduce the complications associated with it. This is a prospective, randomized comparative study conducted in the department of Urology at Christian Medical College, Vellore. Patients with a sterile preoperative urine culture (CFU< 104/ml) undergoing TURP will be included. Patients will receive either one day or 3 days of intravenous Amikacin(15mg/Kg). Clinical examination and urine culture of the patients will be performed pre operatively and 5-7 days postoperatively. Post-operative bacteriuria rate (CFU> 104/ml) will be considered as significant. A follow up at 4 weeks will be done either through an OPD visit or a telephonic interview. Postoperative bacteriuria, symptomatic UTI and development of sepsis and other complications will be recorded. The efficacy (non inferiority) of single versus 3 doses of intravenous Amikacin will be assessed. |