| CTRI Number |
CTRI/2018/02/012087 [Registered on: 22/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
21/02/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
B cell phenotyping in malaria patients |
|
Scientific Title of Study
|
B cell phenotyping, TLR4 expression determination, anti-parasite antibody profiling of serum samples and epidemiological data collection of patients diagnosed with malaria and comparison with healthy controls and non malarial-fever participants at a tertiary referral centre |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Version 1 dated 12th June 2013 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shobhona Sharma |
| Designation |
Professor |
| Affiliation |
Department of Biological Sciences TIFR |
| Address |
Department of Biological Sciences
Tata Institute of Fundamental Research Homi Bhabha Road Mumbai 400 005
Mumbai (Suburban)
MAHARASHTRA
400 005
India |
| Phone |
|
| Fax |
|
| Email |
sharma@tifr.res.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nithya Gogtay |
| Designation |
Professor(Additional) |
| Affiliation |
Department of Clinical Pharmacology GSMC and KEM hospital |
| Address |
Department of Clinical Pharmacology Seth G.S. Medical College and K.E.M. Hospital
Parel Mumbai 400 012
Mumbai (Suburban)
MAHARASHTRA
400 012
India |
| Phone |
|
| Fax |
|
| Email |
njgogtay@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nithya Gogtay |
| Designation |
Professor(Additional) |
| Affiliation |
|
| Address |
Department of Clinical Pharmacology Seth G.S. Medical College and K.E.M. Hospital
Parel Mumbai 400 012
Mumbai (Suburban)
MAHARASHTRA
400 012
India |
| Phone |
|
| Fax |
|
| Email |
njgogtay@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Institute of Fundamental Research |
|
|
Primary Sponsor
|
| Name |
Tata Institute of Fundamental Research |
| Address |
Dept of Biological Sciences
Tata Institute of Fundamental Research Homi Bhabha Road Mumbai 400 005
|
| Type of Sponsor |
Research institution |
|
|
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 Nithya Gogtay |
Department of Clinical Pharmacology |
Department of Clincal Pharmacology 1st Floor MS building GSMC and KEMH Parel Mumbai
Mumbai (Suburban)
MAHARASHTRA |
2224174420
njgogtay@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee II Seth GS Medical College and KEM Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Malaria Patients(P vivax and P falciparum)
Non malaria patients
Healthy volunteers, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
B cell phenotyping |
Through this hypothesis generating study we hope to establish if there is a disturbance in the peripheral B cell subsets of patients suffering an acute episode of vivax and falciparum malaria in a hyperendemic area relative to normal healthy controls and non malarial fever patients This will give some indication of defense against malaria and its impact on recovery from the disease or even what may precipitate repeated attacks The study in its present form constitutes basic research and may or may not have an eventual application. It will however aid in understanding the pathogenesis of malaria |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Females and males of age 5 and above and upto the age of 70 years with clinically suspected malaria on treatment with antimalarials and/or uncomplicated symptomatic malaria (proven) as indicated by the presence of blood smears positive for P falciparum or P. vivax asexual parastemia
Participants (living/working with the malaria patients) of either gender with age more than 18 and upto a maximum of 70 years
Participants of either gender with age more than 18 (upto a maximum of 70 yers) and suffering from non- malarial fever
Willing to participate in this study and ability to comply with the study protocol |
|
| ExclusionCriteria |
| Details |
Inability to comprehend or unwillingness to follow the study protocol.
Complicated malaria patients ( patients with cerebral malaria multiple organ dysfunction severe anemia)
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percentage of B cell subsets TLR4 expression and antiparasite antibody profiles on day 1 (main) and day 30 (preferably) |
Blood collection will be done on Day 1 and Day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
Final Enrollment numbers achieved (Total)= "83"
Final Enrollment numbers achieved (India)="83" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2013 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The immune system is a remarkable defense against
potentially pathogenic microorganisms B lymphocytes derive from
lymphoid progenitor cells which in turn are derived from hematopoietic stem
cells B cell development occurs in the
bone marrow and involves the sequential differentiation of stem cells into
proB preB and then immature B cells Animal studies in mouse models of malaria
have shown an increase in the immature B cell population Similarly in Kisumu
city Kenya which is hyperendemic for malaria children suffering from
falciparum malaria have a large proportion of immature B cells in the
peripheral blood This is relative to normal controls Study of these immature
cells may help in the understanding of the disease pathogenesis The present
study will be similar to the one done in Kenya and will evaluate the proportion
of immature B cells in peripheral blood of adults and children suffering from
vivax and falciparum malaria The controls will be those with fevers that are
not malaria (smear negative) as also normal healthy participants The present
study constitutes basic research and may or may not have an eventual application However it will aid in understanding the pathogenesis of malaria |