CTRI Number |
CTRI/2015/09/006220 [Registered on: 28/09/2015] Trial Registered Prospectively |
Last Modified On: |
27/05/2020 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Medical Device |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Evaluation of BIP Foley catheter in the prevention of catheter associated urinary tract infections in Indian Population (Clinical Phase IV Trial). |
Scientific Title of Study
Modification(s)
|
Evaluation of BIP Foley catheter in the prevention of catheter-associated urinary tract infections in Indian population (Clinical Phase IV Trial) |
Secondary IDs if Any
Modification(s)
|
Secondary ID |
Registry |
ET1506001 Version 01 Dated 01/06/15 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Bhaumik Mody |
Address |
916, Devpath Complex,
B/h Lal Bunglow, Off C.G. Road, Ellisbridge
Ahmadabad GUJARAT 380009 India |
Phone |
09825060463 |
Fax |
|
Email |
bhaumik.mody@ethitrials.com |
|
Details Contact Person Scientific Query
|
Name |
Dr Bhaumik Mody |
Address |
916, Devpath Complex,
B/h Lal Bunglow, Off C.G. Road, Ellisbridge
Ahmadabad GUJARAT 380009 India |
Phone |
09825060463 |
Fax |
|
Email |
bhaumik.mody@ethitrials.com |
|
Details Contact Person Public Query
|
Name |
Mr Umang Suthar |
Address |
916, Devpath Complex,
B/h Lal Bunglow, Off C.G. Road, Ellisbridge
Ahmadabad GUJARAT 380009 India |
Phone |
079-40029913 |
Fax |
|
Email |
umang.suthar@ethitrials.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
Bactiguard AB |
Address |
Box 5070
102 42 Stockholm
Sweden |
Type of Sponsor |
Pharmaceutical industry-Global |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
No of Sites = 6 |
Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Swati Upadhyay |
Apollo Hospitals International Limited |
Consultant Surgeon, Department of General Surgery
Apollo Hospitals International Limited
Bhat, GIDC Estate,
Gandhinagar - 382428 Ahmadabad |
079-66701800 079-66701843 drswatipandit@yahoo.co.in |
Dr CH Santoshbabu |
Gandhi Hospital |
Department of General Surgery, 6th Floor, main building, Gandhi Hospital, Musheerabad, Secunderabad, Hyderabad - 500003, Telangana Hyderabad |
040-27502742
drchsantosh@gmail.com |
Dr HL Trivedi |
Institute of Kidney Diseases and Research Centre (IKDRC) |
Professor in Nephrology and Director,
Smt. G R Doshi and Smt K M Mehta, Institute of Kidney Diseases and Dr H L Trivedi Institute of Transplantation Sciences,
Civil Hospital Campus, Asarwa, Ahmedabad -16 Ahmadabad |
07922685600 07922682811 drhtrivedi@yahoo.co.in |
Dr Dilip Kumar Pal |
IPGMER & SSKM Hospital |
Head of Urology, Institute of Post Graduate Medical Education and Research, 244 A.J.C. Bose Road, Kolkata 700020 Kolkata |
09804784979
drdkpal@yahoo.co.in |
Dr Bikash Bawri |
Marwari Hospital and Research Center |
Marwari Hospital and Research Center, Athgaon, Guwahati - 781008 Kamrup |
0361-2602738
drbikashbawri@yahoo.com |
Dr S K Singh |
Postgraduate Institute of Medical Education & Research, Chandigarh |
Professor and Head(Unit II)
Department of Urology,Postgraduate Institute of Medical Education & Research
Sector - 12,
Chandigarh Chandigarh |
0172-2756321 0172-2744401 sharwanksingh2002@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
No of Ethics Committees= 6 |
Name of Committee |
Approval Status |
ECRC Hospital Ethics Committee |
Approved |
Ethics Committee-Apollo Hospitals International Limited |
Approved |
IKDRC-ITS Ethics Committee |
Approved |
Institutional Ethics Committee-Gandhi Medical College |
Approved |
Institutional Ethics Committee-PGIMER |
Approved |
IPGME&R Reserach Oversight Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Prevention of Urinary Tract Infection |
|
Intervention / Comparator Agent
Modification(s)
|
Type |
Name |
Details |
Intervention |
BIP Foley Catheter |
Appropriate size of BIP Foley catheter will be inserted into the vesical cavity of the bladder through the urethra. Catheterisation will be done for at least 48 hours and and up to clinically relevant, but not more than 30 days. |
Comparator Agent |
Standard Foley Catheter |
Appropriate size of standard Foley catheter will be inserted into the vesical cavity of the bladder through the urethra. Catheterisation will be done for at least 48 hours and and up to clinically relevant, but not more than 30 days. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
Adult patients (>18 years)
Patients who are judged of need for indwelling urethral catheter (Foley catheter for at least 48 hours and up to 30 days) |
|
ExclusionCriteria |
Details |
Patient treated with antibiotics for urinary tract infection (UTI)
Patient receiving prophylactic antibiotics for catheterization
Latex Allergy
Patients with surgical interventions in the urinary tract that may interfere with the study results according to the investigator criteria
Pregnant or breastfeeding women |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
An Open list of random numbers |
Blinding/Masking
|
Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Incidence of CAUTI according to CDC criteria (in % and No/1000 catheter days) |
30 days |
|
Secondary Outcome
|
Outcome |
TimePoints |
• Antibiotic use for treatment of urinary tract infections
• Number of spontaneous urinary and blood cultures
• Duration of hospitalization
• Bacteriuria (≥ 105 CFU/ml)
• Safety (ADEs) |
30 days |
|
Target Sample Size
|
Total Sample Size="1000" Sample Size from India="1000" |
Phase of Trial
|
Phase 4 |
Date of First Enrollment (India)
|
05/10/2015 |
Date of First Enrollment (Global) |
No Date Specified |
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
|
|
Brief Summary
|
This is a prospective, randomized, multi-center, controlled, parallel group clinical phase IV study. The study will include at least 3 evaluation points: patient inclusion into the study, patient assessment at catheter removal and patient assessment at follow up 2 days after catheter removal. The catheter will be removed according to clinical praxis (i.e. if it is no longer needed or when infection occurs). |