| CTRI Number |
CTRI/2019/11/021932 [Registered on: 08/11/2019] Trial Registered Prospectively |
| Last Modified On: |
07/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Single Center Observational Trial |
| Study Design |
Other |
|
Public Title of Study
|
Accuracy Testing of Hemex Malaria Device (GazelleTM) |
|
Scientific Title of Study
|
"Pilot and Validation studies of a new malaria and sickle cell diagnostic device." |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| GZL-M10-PTO-0001, Version 1, 25/02/2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Praveen K Bharti |
| Designation |
Scientist ‘E’(PhD) |
| Affiliation |
ICMR-National Institute of Research in Tribal Health |
| Address |
ICMR-National Institute of Research in Tribal Health
Ministry of Health, Govt. of India, Nagpur Road,
P.O. Garha,
Jabalpur
Jabalpur
MADHYA PRADESH
482003
India |
| Phone |
9926335201 |
| Fax |
|
| Email |
saprapbs@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Praveen K Bharti |
| Designation |
Scientist ‘E’(PhD) |
| Affiliation |
ICMR-National Institute of Research in Tribal Health |
| Address |
ICMR-National Institute of Research in Tribal Health
Ministry of Health, Govt. of India, Nagpur Road,
P.O. Garha,
Jabalpur
MADHYA PRADESH
482003
India |
| Phone |
9926335201 |
| Fax |
|
| Email |
saprapbs@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Praveen K Bharti |
| Designation |
Scientist ‘E’(PhD) |
| Affiliation |
ICMR-National Institute of Research in Tribal Health |
| Address |
ICMR-National Institute of Research in Tribal Health
Ministry of Health, Govt. of India, Nagpur Road,
P.O. Garha,
Jabalpur
MADHYA PRADESH
482003
India |
| Phone |
9926335201 |
| Fax |
|
| Email |
saprapbs@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Hemex Health Inc.
4640 SW Macadam Ave #250, Portland, OR 97239, United States |
|
|
Primary Sponsor
|
| Name |
Hemex Health Inc |
| Address |
4640 SW Macadam Ave 250, Portland, OR 97239, United States |
| Type of Sponsor |
Other [Private Company] |
|
|
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 Praveen K Bharti |
National Institute of Research in Tribal Health (NIRTH) |
ICMR-National Institute of Research in Tribal Health
Ministry of Health, Govt. of India, Nagpur Road,
P.O. Garha,
Jabalpur-482003
Jabalpur
MADHYA PRADESH |
9926335201
saprapbs@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ECR/734/Inst/MP/2015 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B509||Plasmodium falciparum malaria, unspecified, (2) ICD-10 Condition: B529||Plasmodium malariae malaria without complication, (3) ICD-10 Condition: B530||Plasmodium ovale malaria, (4) ICD-10 Condition: B519||Plasmodium vivax malaria without complication, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Present with uncomplicated malaria (fever),Other symptomatic patients (fever, chills etc.) visiting the clinic/lab for various
diagnostic purposes, Informed consent for all fresh or frozen samples will be obtained from the patient or obtained from the parent/guardian in case the patient is a minor.
|
|
| ExclusionCriteria |
| Details |
Presence of any serious or chronic illness requiring medical attention
Informed consent not provided
Malaria diagnosis within the last two months
Treatment for malaria in last two months
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary endpoint of the study is the accuracy of the Hemex Malaria device |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A
|
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
11/11/2019 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The purpose of this Study is to compare the performance of a new malaria diagnostic device(Gazelle) with the current malaria diagnostic technologies such as RDT (Rapid Diagnostic Test),microscopy and PCR (Polymerase Chain Reaction). The study rationale is that Hemex Malariadevice (Gazelle) is faster, easier and comparable to (as good as) microscopy and/or has betteraccuracy for malaria parasites than RDTs, regardless of the species. The study enrollsapproximately 200 patients who presents with fever to the clinic and each patient sample will betested with Gazelle and RDT, and then compare with microscopy and PCR. |