| CTRI Number |
CTRI/2014/03/004485 [Registered on: 19/03/2014] Trial Registered Retrospectively |
| Last Modified On: |
18/09/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to determine safety and efficacy of patients receiving colistin. |
|
Scientific Title of Study
|
A prospective observational study of real world treatment outcomes in patients receiving colistimethate sodium |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Senthur Nambi |
| Designation |
Consultant- Infectious Diseases |
| Affiliation |
Apollo Hospitals |
| Address |
Apollo Hospitals
21, Greams lane, off Greams Road
Chennai
TAMIL NADU
600006
India |
| Phone |
044-65367136 |
| Fax |
|
| Email |
senthurnambi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Senthur Nambi |
| Designation |
Consultant- Infectious Diseases |
| Affiliation |
Apollo Hospitals |
| Address |
Apollo Hospitals
21, Greams lane, off Greams Road
TAMIL NADU
600006
India |
| Phone |
044-65367136 |
| Fax |
|
| Email |
senthurnambi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Rahul Namjoshi |
| Designation |
Project Manager |
| Affiliation |
Cipla Ltd, Medical Services |
| Address |
Cipla Ltd.;3rd Floor, Raj Plaza, LBS Marg, Vikhroli West, Mumbai
Mumbai
MAHARASHTRA
400083
India |
| Phone |
022-25716057 |
| Fax |
02225787855 |
| Email |
rahul.namjoshi@cipla.com |
|
|
Source of Monetary or Material Support
|
| Cipla Ltd, Bellasis Road, Mumbai Central, Mumbai, Phone 02223082891 Fax 02225787855 |
|
|
Primary Sponsor
|
| Name |
Cipla Ltd |
| Address |
Bellasis Road, Mumbai Central, Mumbai, Phone 02223082891 Fax 02225787855 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Senthur Nambi |
Apollo Hospitals |
Room No. 5, Department of Infectious Diseases, Apollo Hospitals,
21 Greams lane, off Greams Road
Chennai- 600006
Chennai
TAMIL NADU |
044-65367136
-
senthurnambi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, Apollo Hospitals Chennai- for Dr.Senthur Nambi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Gram negative multidrug resistant bacterial infections, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Colistimethate sodium Inj. |
•The dosage (Strengths available 1 & 2 million IU) of colistimethate sodium, given as IV injection, will be as per the prescribing information or discretion of the treating physician
•The duration and/or change of treatment will be as per the discretion of treating physician, depending on the microbiological assessment, diagnosis, patient’s condition and response to treatment |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Greater than 18 years
2.A written informed consent
3.Patients suitable for treatment with colistimethate sodium, including immuno-compromised patients |
|
| ExclusionCriteria |
| Details |
1.Patients with hypersensitivity to colistimethate sodium or any exipients of its formulation.
2.Patients with Myasthenia gravis.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Clinical Parameters:Clinical and bacteriological
response to the treatment. |
Throughout the study period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of inpatient mortality |
Throughout the study period |
Incidence and nature of adverse events
|
Throughout the study period |
Incidence of drug related adverse events
|
Throughout the study period |
| Clinically significant changes in the vital signs, systemic examinations, ECG, chest radiograph and laboratory values |
Throughout the study period |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
14/10/2013 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This clinical trial is a prospective observational study for determination of real world treatment outcomes in subjects with gram negative multidrug resistant bacterial infections receiving colistimethate sodium. 100 patients will be recruited in this study at single site in India. Patients will receive the colistimethate sodium treatment as per the discretion of treating physician. Primary outcome measures will be Clinical and bacteriological response to the treatment. Safety parameters will be assessed as a secondary measures.. |