| CTRI Number |
CTRI/2023/05/052947 [Registered on: 19/05/2023] Trial Registered Prospectively |
| Last Modified On: |
26/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to evaluate Performance and Safety of the Bactiguard Central Venous Catheter in seriously ill patients |
|
Scientific Title of Study
|
A Multicenter, Randomized, Parallel group, Open label, Post Marketing Clinical Investigation Study to assess efficacy and safety of Bactiguard® Central Venous Catheter (CVC) Compared to Standard Central Venous Catheter (CVC) in Critically ill Patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BCR-BAC-001 Version 1.0 Dated 10 Nov 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Yatin Mehta |
| Designation |
Chairman,Critical Care and Anaesthesia, Principal Investigator |
| Affiliation |
Medanta The Medicity |
| Address |
Institute of Critical Care and
Anesthesia.
Medanta The Medicity, Sector
38, Gurgaon, Haryana – 122001,
India
Gurgaon
HARYANA
122001
India |
| Phone |
0124-4141414 |
| Fax |
|
| Email |
yatinmehta@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neeta Nargundkar |
| Designation |
Managing Director |
| Affiliation |
Biosphere Clinical Research Pvt. Ltd |
| Address |
SB 02, 03 and 04, Second Floor,
Highland Corporate Centre,
Kapurbawadi Junction, Thane
Thane
MAHARASHTRA
400607
India |
| Phone |
02241006794 |
| Fax |
|
| Email |
drneeta@biospherecro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neeta Nargundkar |
| Designation |
Managing Director |
| Affiliation |
Biosphere Clinical Research Pvt. Ltd |
| Address |
SB 02, 03 and 04, Second Floor,
Highland Corporate Centre,
Kapurbawadi Junction, Thane
Thane
MAHARASHTRA
400607
India |
| Phone |
02241006794 |
| Fax |
|
| Email |
drneeta@biospherecro.com |
|
|
Source of Monetary or Material Support
|
| Bactiguard AB
Aadi Health Care, Property No. A-20/1, F.F., Rewari Line Industrial Area, Mayapuri Phase-1, New Delhi-110064 India |
|
|
Primary Sponsor
|
| Name |
Bactiguard AB |
| Address |
Aadi Health Care, Property No. A-20/1, F.F., Rewari Line Industrial Area, Mayapuri Phase-1, New Delhi-110064 India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sujit Kshirsagar |
B J Govt. Medical College And Sassoon General Hospital,, |
Department of Anaesthesiology,1st
Floor ,Block 11, Jai Prakash
Narayan Road, Near Pune Railway
Station, Pune-411001,
Maharashtra,
Pune
MAHARASHTRA |
8983741147
bjsujit@gmail.com |
| Dr Parth Patel |
B. J. Medical College and Civil Hospital Ahmedabad |
F3, 1st floor, Department
of Anesthesiology, Haripura,
Asarwa, Ahmedabad-380016,
Gujarat, India
Ahmadabad
GUJARAT |
9924119778
parthtonypatel@gmail.com |
| Dr Richa Giri |
G.S.V.M. Medical College Kanpur |
Post Graduate Department of
Medicine, GSVM Medical
College, Swaroop Nagar, Kanpur
– 208002, Uttar Pradesh
Kanpur Nagar
UTTAR PRADESH |
8400331045
drrichagiri.gsvm@gmail.com |
| Dr Rajeev Kumar Dubey |
Institute Of Medical Sciences, Banaras Hindu University |
Department of Anaesthesiology, Institute of Medical Sciences,
Banaras Hindu University, Varanasi-
221005 , Uttar Pradesh
Varanasi
UTTAR PRADESH |
9839927283
rajeevdubeyrk@gmail.com |
| Dr Yatin Mehta |
Medanta the Mediciti |
Institute of Critical Care and
Anesthesia.,1st
floor,Medanta The Medicity, Sector
38, Gurgaon, Haryana – 122001,
India
Gurgaon
HARYANA |
0124-4141414
yatinmehta@hotmail.com |
| Dr H G Manjunath |
Mysore Medical College And Research Institute And Associated Hospitals, K.R. Hospital |
Department of
Anaesthesia, Irwin Road, Mysuru-
570001., Karnataka
Mysore
KARNATAKA |
9448054368
drhgmanjunath@hotmail.com |
| Dr M Radhakrishnan |
National Institute Of Mental Health And Neurosciences (NIMHANS) |
Department of
Neuroanaesthesia & Neurocritical
Care,Hosur Road, Near Bangalore
Milk Dairy, Bengaluru, Karnataka -
5600029, , Bengaluru
Bangalore
KARNATAKA |
9632589296
mrks1974@gmail.com |
| Dr Jay Prakash |
Rajendra Institute Of Medical Sciences(RIMS) Ranchi |
Department of Critical Care
Medicine,Bariatu, Ranchi-
834009, Jharkhand
Ranchi
JHARKHAND |
8084715507
dr.jayprakash@rediffmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 14 |
| Name of Committee |
Approval Status |
| Dr. Ram Manohar Lohia Institute of Medical Sciences, Institutional Ethics Committee Lucknow |
Approved |
| Ethics Committee GSVM Medical College |
Approved |
| Ethics committee Metas Adventist Hospital |
Submittted/Under Review |
| Institute Ethical Committee, Institute of Medical Sciences, Banaras Hindu University |
Approved |
| Institutional Ethics Commitee, Yashwantrao Chavan Memorial Hospital |
Submittted/Under Review |
| Institutional Ethics Committee Ruby General Hospital Pvt.Ltd |
Submittted/Under Review |
| Institutional Ethics Committee B J Government Medical College and Sassoon General Hospital |
Submittted/Under Review |
| Institutional Ethics Committee Mysore Medical College & & Research Institute and Associated Hospitals, |
Approved |
| Institutional Ethics Committee Rajendra Institute of Medical Sciences |
Submittted/Under Review |
| Institutional Ethics Committee, B J Medical College, Civil Hospital, Ahmedabad |
Submittted/Under Review |
| Kasturbha Medical college and Kasturbha Hospital Institutional Ethics Committee |
Submittted/Under Review |
| Medanta Institutional Ethics Committee |
Submittted/Under Review |
| NIMHANS Institute Ethics Committee |
Approved |
| Vydehi Institute Ethics Committee |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bactiguard Central Venous Catheter (CVC) |
upto 14 days |
| Comparator Agent |
Standard Central Venous Catheter (CVC) |
Upto 14 Days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female patients of age between 18 to 75 years both inclusive.
2. Patients hospitalised in intensive care units expected to require indwelling central venous catheterization for ≥ 3 days (jugular
vein, subclavian vein, femoral vein).
3. Patients or his/her legally authorized representative (if applicable) who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures. |
|
| ExclusionCriteria |
| Details |
1. Patients with suspected catheter related infections.
2. Patients receiving an initial study catheter through guide wire exchange.
3. Patients with malignant diseases and unlikely to survive for the next 28 days in the opinion of the intensive care unit consultant;
4. Patients hospitalised for severe burn injuries;
5. Patient with a history of thrombocytopenia
6. Patient with a history of bleeding disorders
7. Patient with signs of infection, wounds and subcutaneous haematoma close to the puncture site
8. Patients with, in the opinion of the investigator, a situation that is not suitable for indwelling placement, including allergy to the
catheter material, confirmed deep vein thrombosis and abnormal anatomical structure post-surgical changes in the insertion site.
9. Current enrolment in a clinical study of any other unapproved investigational intravenous device within 30 days prior to signing informed consent.
10. Female patients who are pregnant or lactating. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Incidence of central line–associated bloodstream infection
(CLABSI) |
14 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The incidence of CVC related adverse events (AEs) and
severe adverse events (SAEs) from baseline to end of study. |
14 Days |
Incidence of catheter-related thrombosis [Time Frame: From
central venous catheter insertion until date of catheter removal] |
14 Days |
| Duration of Stay in the Intensive Care Unit (ICU). |
14 Days |
| Duration of Hospitalization |
14 Days |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
15/06/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is A Multicenter, Randomized, Parallel group, Open label, Post Marketing Clinical Investigation Study to assess efficacy and safety of Bactiguard® Central Venous Catheter (CVC) compared to Standard Central Venous Catheter (CVC) in critically ill patients. 500 subjects will be enrolled in the study
The Objective is to evaluate the efficacy and safety of Bactiguard Central Venous Catheter (CVC) compared to Standard Central Venous Catheter (CVC) in critically ill patients.
All subjects will be assessed for primary endpoint i.e. Incidence of central line–associated bloodstream infection (CLABSI) from central venous catheter insertion until end of the study and secondary endpoint i.e. Incidence of CVC related adverse events (AEs) and severe adverse events (SAEs) from baseline to end of study, Incidence of catheter-related thrombosis from central venous catheter insertion until date of catheter removal ,Duration of Stay in the Intensive Care Unit (ICU) and Duration of Hospitalization
|