| CTRI Number |
CTRI/2026/01/102503 [Registered on: 30/01/2026] Trial Registered Prospectively |
| Last Modified On: |
30/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study to Check a Rapid Test for Melioidosis |
|
Scientific Title of Study
|
Clinical sensitivity study for Active Melioidosis Detect™ Plus (AMD Plus) rapid test |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chiranjay Mukhopadhyay |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Microbiology,
Basic Science Building,
Kasturba Medical College,
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845513057 |
| Fax |
|
| Email |
chiranjay.m@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chiranjay Mukhopadhyay |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Microbiology,
Basic Science Building,
Kasturba Medical College,
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845513057 |
| Fax |
|
| Email |
chiranjay.m@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chiranjay Mukhopadhyay |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Microbiology,
Basic Science Building,
Kasturba Medical College,
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845513057 |
| Fax |
|
| Email |
chiranjay.m@manipal.edu |
|
|
Source of Monetary or Material Support
|
| InBios International, Inc.
307 Westlake Ave N, Suite 300,
Seattle, WA 98109 |
|
|
Primary Sponsor
|
| Name |
InBios International, Inc. |
| Address |
InBios International, Inc.
307 Westlake Ave N, Suite 300,
Seattle, WA 98109 |
| Type of Sponsor |
Other [Biotechnology corporation] |
|
|
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 Chiranjay Mukhopadhyay |
Kasturba Medical College |
Department of Microbiology,
Basic Science Building,
Kasturba Medical College, Manipal
Udupi
KARNATAKA |
9845513057
chiranjay.m@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A488||Other specified bacterial diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Participants aged 2 years and above at the time of enrolment
Participants or their legally acceptable representative willing and able to provide written informed consent or assent as per local guidelines
Patients presenting with clinical features suggestive of melioidosis including sepsis of unknown cause or clinically suspected melioidosis as documented by the treating physician
Patients from melioidosis endemic regions as determined by the treating physician |
|
| ExclusionCriteria |
| Details |
Patients who have received antibiotics active against Burkholderia pseudomallei for more than 48 hours prior to enrolment
Previous enrolment in this study
Inmate or deprived of freedom by court order |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| PPA and NPA of AMD Plus vs reference standard |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Performance stratified by sample type, antibiotic exposure status, & time since symptom onset |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="283"
Sample Size from India="283"
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)
|
15/03/2026 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a two phase observational diagnostic study evaluating the performance of the Active Melioidosis Detect Plus Rapid Test for the diagnosis of melioidosis. Phase one is a retrospective laboratory based pilot study using archived Burkholderia pseudomallei isolates to assess feasibility and analytical performance of the test. Phase two is a prospective cross sectional study conducted in patients with suspected melioidosis, where the AMD Plus Rapid Test results will be compared with standard culture and molecular reference methods. The study aims to determine the diagnostic sensitivity and specificity of the test in endemic settings. |