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Development of Melioidosis Diagnostic Assay System

Not Applicable
Conditions
Health Condition 1: B998- Other infectious disease
Registration Number
CTRI/2020/06/025951
Lead Sponsor
InBios International Inc
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

At least 5 years of age.

Subject able to give written informed consent/assent as appropriate. Present with at least one of the following symptoms of melioidosis:

Sepsis with unknown cause at the time of study enrollment, or Suspected cases of melioidosis by physician with a wide range of symptoms including: Type 2 diabetes with ulceration and abscesses and/or unhealed wounds; Swelling, open wounds/skin abrasions with pus; Multiple abscesses in kidneys, liver, spleen, prostate; Respiratory tract symptoms (sore throat, shortness of breath, pneumonia, cough); Fever with chills and other signs and symptoms consistent with melioidosis; Headache and other signs and symptoms consistent with melioidosis; Muscle soreness and other signs and symptoms consistent with melioidosis; Weight loss and other signs and symptoms consistent with melioidosis.

Exclusion Criteria

Currently taking or have taken ceftazidime or meropenem targeting B. pseudomallei in the last 48 hours.

Previous enrollment in this study.

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To evaluate and marketised a noble diagnostic tool for one of the infectious disease like MelioidosisTimepoint: One day for each subject for AMD testing, and up to 6 days longer for collection of additional specimens for a second reference test
Secondary Outcome Measures
NameTimeMethod
Active Melioidosis Detect Rapid test will help to diagnose patients with melioidosis within short period of timeTimepoint: One day for each subject for AMD testing, and up to 6 days longer for collection of additional specimens for a second reference test
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