| CTRI Number |
CTRI/2018/02/012183 [Registered on: 27/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
11/04/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
A Registry Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of usage and outcomes of Polymyxin B in serious bacterial infection |
|
Scientific Title of Study
|
Study of usage and outcomes of Polymyxin B for Systemic Bacterial Infections in Indian patients: A Registry Study |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| PYMX/REG-11/2016, Version No. 01, Dated: 23 Mar 2017 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Agam Shah |
| Designation |
Head, Clinical operations |
| Affiliation |
Wockhardt Limited |
| Address |
Wockhardt towers, Bandra Kurla complex, Mumbai
Mumbai
MAHARASHTRA
400051
India |
| Phone |
02226596762 |
| Fax |
02226523905 |
| Email |
ashah@wockhardt.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Agam Shah |
| Designation |
Head, Clinical operations |
| Affiliation |
Wockhardt Limited |
| Address |
Wockhardt towers, Bandra Kurla complex, Mumbai
MAHARASHTRA
400051
India |
| Phone |
02226596762 |
| Fax |
02226523905 |
| Email |
ashah@wockhardt.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Ashish Mane |
| Designation |
Manager, Clinical Operations |
| Affiliation |
Wockhardt Limited |
| Address |
Wockhardt towers, Bandra Kurla complex, Mumbai
Mumbai
MAHARASHTRA
400051
India |
| Phone |
02226596896 |
| Fax |
02226523905 |
| Email |
ashishm@wockhardt.com |
|
|
Source of Monetary or Material Support
|
| Wockhardt Limited, Wockhardt Towers, Bandra – Kurla Complex, Bandra East, Mumbai - 400051 |
|
|
Primary Sponsor
|
| Name |
Wockhardt Limited |
| Address |
Wockhardt Towers, Bandra – Kurla Complex, Bandra East, Mumbai |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajesh Kumar Pande |
BLK Super Speciality Hospital |
Emergency and Acute Care Medicine, BLK Super Speciality Hospital, Pusa Road, Rajinder Nagar,
New Delhi
New Delhi
DELHI |
01130403040
rajeshmaitree2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of Dr. B.L. Kapur Memorial Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Indian patients who are administered Polymyxin B for management of systemic bacterial infection as per routine clinical practice, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
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 their systemic bacterial infection |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Pattern of usage of Polymyxin B in various healthcare setups
2. Outcomes associated with therapy with Polymyxin B
|
1. At enrolment
2. At end of study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Demographic and disease distribution of usage of Polymyxin B
2. Incidence of side effects and / or development of abnormal laboratory parameters
3. Cost Analysis of Polymyxin B therapy
|
1. At enrolment
2. Throughout polymyxin B treatment
3. Throughout polymyxin B treatment |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
16/08/2017 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Polymyxins are polycationic antimicrobial peptides that are currently the last-resort antibiotics for the treatment of multidrug-resistant, Gram-negative bacterial infections. With growing incidence of drug resistant infections in India, the use of polymyxins are increasing consequently. However, the drug utilization patterns of Polymyxin B in management of systemic bacterial infections in India are still limited.
This present study plans 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. |