| CTRI Number |
CTRI/2018/03/012366 [Registered on: 06/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
20/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Registry |
| Study Design |
Other |
|
Public Title of Study
|
Study of usage and outcomes of Polymyxin B in serious Bacterial Infections in Indian patients |
|
Scientific Title of Study
|
Study of usage and outcomes of Polymyxin B for Systemic Bacterial Infections in Indian patients: A Prospective Registry Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Yatin Mehta |
| Designation |
Chairman,Critical Care and Anesthiology |
| Affiliation |
Medanta The Medicity |
| Address |
Institute of Critical Care and Anesthesia,1st Floor,Sector-38,Gurgaon
Gurgaon
HARYANA
122001
India |
| Phone |
01244141414 |
| Fax |
|
| Email |
yatin.mehta@medanta.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yatin Mehta |
| Designation |
Chairman,Critical Care and Anesthiology |
| Affiliation |
Medanta The Medicity |
| Address |
Institute of Critical Care and Anesthesia 1st Floor,Sector-38,Gurgaon
Gurgaon
HARYANA
122001
India |
| Phone |
01244141414 |
| Fax |
|
| Email |
yatin.mehta@medanta.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yatin Mehta |
| Designation |
Chairman,Critical Care and Anesthiology |
| Affiliation |
Medanta The Medicity |
| Address |
Institute of Critical Care and Anaesthesia ,1st floor,Sector-38,Gurgaon
Gurgaon
HARYANA
122001
India |
| Phone |
01244141414 |
| Fax |
|
| Email |
yatin.mehta@medanta.org |
|
|
Source of Monetary or Material Support
|
| Wockhardt Limited, Wockhardt Towers, Bandra – Kurla Complex, Bandra East, Mumbai |
|
|
Primary Sponsor
|
| Name |
Wockhardt Limited |
| Address |
Wockhardt Towers, Bandra – Kurla Complex, Bandra East, Mumbai |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Medanta The Medicity |
Institute of Critical Care and Anesthesia,1st Floor, Sec-38,Gurgaon,Haryana-122001 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Yatin Mehta |
Medanta The Medicity |
2nd floor,Medanta Institute of Critical Care and Anesthesiology
Gurgaon
HARYANA |
01244141414
yatin.mehta@medanta.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medanta Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A498||Other bacterial infections of unspecified site, patients with management of systemic bacterial infection , |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. An Adult (> 18 years) Indian patient of either gender who is reported to have received at least 1 dose of Polymyxin B for management of systemic bacterial infection
2. Patient provides consent for recording of patient related data from medical records into the registry
|
|
| ExclusionCriteria |
| Details |
1. Adult less than 18 years of age
2. Patients not received at least 1 dose of Polymyxin B for management of systemic bacterial infection |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pattern of usage of Polymyxin B in various healthcare setups
2. Outcomes associated with therapy with Polymyxin B
|
12months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Demographic and disease distribution of usage of Polymyxin B
|
12 months |
| Incidence of side effects and / or development of abnormal laboratory parameters |
12 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
N/A |
|
Date of First Enrollment (India)
|
11/05/2017 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
To be published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This present study aims to monitor and record the patterns of usage, clinical practices and the determinants & outcomes (efficacy and safety) of such practices in regards to administration of Polymyxin B in large Indian population in real life scenarios for management of systemic bacterial infections as per routine clinical practice. |