| CTRI Number |
CTRI/2013/08/003876 [Registered on: 05/08/2013] Trial Registered Retrospectively |
| Last Modified On: |
30/07/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Proteomics study in patients with severe malaria |
|
Scientific Title of Study
|
Evaluation of host immune responses and parasite proteome in patients with severe/complicated malaria |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Version 4 dated 15th march 2013 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nithya Gogtay |
| Designation |
Professor (Additional) |
| Affiliation |
Department of Clinical Pharmacology GSMC and KEM hospital |
| Address |
Department of Clinical Pharmacology 1st Floor GSMC and KEMH Acharya Donde Marg Parel Mumbai 400012
Mumbai (Suburban)
MAHARASHTRA
400012
India |
| Phone |
|
| Fax |
|
| Email |
njgogtay@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjeeva Srivastava |
| Designation |
Professor |
| Affiliation |
Department of Bio sciences and Bioengineering IIT |
| Address |
Department of Biosciences and Bioengineering Indian Institute of Technology Powai Mumbai 400 076
Mumbai (Suburban)
MAHARASHTRA
400076
India |
| Phone |
|
| Fax |
|
| Email |
sanjeeva@iitb.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nithya Gogtay |
| Designation |
Professor(Additional) |
| Affiliation |
|
| Address |
Department of Clinical Pharmacology 1st Floor GSMC and KEMH Acharya Donde Marg Parel Mumbai 400012
Mumbai (Suburban)
MAHARASHTRA
400012
India |
| Phone |
|
| Fax |
|
| Email |
njgogtay@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Institute of Technology Powai Mumbai |
|
|
Primary Sponsor
|
| Name |
Department of Biosciences and Bioengineering Indian Institute of Technology |
| Address |
Department of Biosciences and Bioengineering Indian Institute of Technology Powai Mumbai 400 076
|
| 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 |
1st floor MS building GSMC and KEMH Parel Mumbai400012
Mumbai (Suburban)
MAHARASHTRA |
2224174420
njgogtay@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board GSMC and KEM Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Severe malaria(P vivax and P falciparum)
Non malarial fever
Healthy participants, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Host immune response |
Expression levels of the identified serum protein sample (200 microlitre)in severe malaria patients will help to correlate the identified marker proteins with disease severity and evaluate the prognostic value of the target proteins Specificity of the identified malaria related serum markers will be evaluated by means of analysis of dengue fever and leptospirosis as febrile controls |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Participants of either sex aged 18 to 65 years both inclusive
Either gender
with a diagnosis of severe/complicated vivax malaria OR with a diagnosis of severe malaria due to mixed infection
Confirmed nonmalaria fever patients dengue fever (serum IgM antibody titre) leptospirosis (microscopic agglutination test)and enteric fever (widal test)
Healthy volunteers as judged by medical history clinical examination and laboratory investigations
Patients or their legally accepted representatives willing to provide written informed consent
|
|
| ExclusionCriteria |
| Details |
Patients with history of significant systematic disease like autoimmune disorders chronic liver diseases psychiatric illness and bleeding disorders etc As judged by history and physical examination
Patients with a diagnosis of complications to dengue leptospirosis or any other infectious disease
A female patient who is pregnant at enrolling
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Serum proteome analysis of patients suffering from severe P vivax and P falciparum malaria infections to get mechnistic insights about disease pathogenesis and host immune response
Identification of potential serum markers associated with severe versus uncomplicated malaria
Correlation of the identified serum markers with disease severity establishment of prognostic host markers of malaria
|
single time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
29/07/2013 |
| 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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Malaria is a
major health problem in Asia and Africa and to date more than 1 million people
die annually due to this disease Lack of early diagnosis effective
vaccines as well as drug resistance remains major challenges The incidence of
malaria from P vivax and P falciparum species
of the malaria parasite and its complications is on the rise worldwide with
reports of mortality from what was thought to be an otherwise benign parasite Proteomic investigations of the P vivax
and P falciparum along with the study
of host immune responses may significantly advance our understanding and
perhaps aid prognosis
This
project aims to perform a comprehensive proteomic analysis of serum samples of
severe P falciparum malaria and P vivax malaria patients admitted in Department
of Clinical Pharmacology Seth GS Medical College and KEM Hospital We will perform the
comparative serum proteome analysis of and healthy controls severe and
non severe FM and VM malaria patients using 2DE and 2D DIGE in combination with
MALDI TOF/TOF MS to decipher disease pathogenesis host immune response and
identification of surrogate protein markers Proteomic and
immunoassay based analysis of the clinical samples will be performed at Department
of Biosciences and Bioengineering Indian Institute of Technology Bombay Powai Mumbai 400 076 India Diagnostic impact of identified serum biomarkers in
clinics and specificity for malaria prediction will be established by
investigation of the disease patterns in large clinical cohorts using
immunoassay-based analysis Panel of identified biomarkers will be tested to
evaluate their efficiency in diagnosis. Expression levels of the identified
serum protein in severe malaria patients will help to correlate the identified
marker proteins with disease severity and evaluate the prognostic value of the
target proteins Specificity of the identified malaria related serum markers will
be evaluated by means of analysis of dengue fever and leptospirosis as febrile
controls
|