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Study to Check a Rapid Test for Melioidosis

Clinical sensitivity study for Active Melioidosis Detect Plus (AMD Plus) rapid test - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/01/102503
Enrollment
283
Registered
2026-01-30
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: A488- Other specified bacterial diseases

Interventions

Intervention1: Nil: Nil

Sponsors

InBios International, Inc.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
PPA and NPA of AMD Plus vs reference standardTimepoint: At baseline

Secondary

MeasureTime frame
Performance stratified by sample type, antibiotic exposure status, & time since symptom onsetTimepoint: At baseline

Countries

India

Contacts

Public ContactDr Chiranjay Mukhopadhyay

Kasturba Medical College, Manipal

chiranjay.m@manipal.edu9845513057

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026