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	Bactiguard AB
Primary Sponsor	Name  Bactiguard AB  Address  Box 5070 102 42 Stockholm Sweden  Type of Sponsor  Pharmaceutical industry-Global
Details of Secondary Sponsor	Name  Address  NIL  NIL
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	Status  Approved/Obtained
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).