An observational study in Melioidosis Pneumonia, sponsored by Myanmar Oxford Clinical Research Unit. Completed at 1 site in Myanmar. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-13.
Sponsored by Myanmar Oxford Clinical Research Unit · Observational
This study will evaluate a new point of care diagnostic test for the diagnosis of melioidosis pneumonia in patients attending outpatient clinics in Yangon, Myanmar
Melioidosis is caused by Burkholderia pseudomallei, a Gram-negative saprophytic environmental bacterium that is an important emerging tropical infection. There are an estimated 165,000 cases and 89,000 deaths world-wide each year. Eighty-four percent of cases are in SE Asia where mortality is 40%; far exceeding most recognised neglected tropical diseases. Pneumonia, secondary to either inhalation of B.pseudomallei or to bacteraemic spread to the lung is the commonest presentation (51%). Annually the highest burden (75%) of infection occurs in the rainy season in (75% in Thailand). Up to 80% patients have at least one recognised risk factor for melioidosis including; diabetes, alcohol-dependence, glucocorticoid therapy, chronic obstructive pulmonary disease (COPD), chronic renal disease and cancer. COPD and diabetes mellitus are amongst the top ten causes of death in Myanmar (2018). Patients with HIV have not been shown to have greater risk of B. pseudomallei than immunocompetent patients.
Melioidosis was discovered in Myanmar in 1911 by British pathologist Alfred Whitmore and his assistant CS Krishnaswami. Yet since 1949 there have been few published cases. Under-reporting is partly due to difficulty in diagnosing melioidosis. Clinical and radiological findings are indistinguishable from tuberculosis. Laboratory diagnosis is challenging, lack of facilities, expertise and awareness of B.pseudomallei results in missed diagnostic opportunities.
Culture is the gold-standard diagnostic method but requires appropriate facilities and expertise which are not readily available in many developing countries like Myanmar. A rapid diagnostic (RDT) test has been developed for low resource settings that has been evaluated in Laos and India. The InBios® Active Melioidosis DetectTM-Lateral Flow Assay (AMD-LFA) detects B.pseudomallei 6-deoxyheptan capsular polysaccharide antigen. Shaw et al demonstrated sensitivity 85.71% (CI:74.61% to 93.25%) and specificity 93.62% (CI:88.23% to 97.04%), with positive predictive value of 85.71% (CI: 75.98% to 91.92%) compared to culture. We propose to evaluate this test for the diagnosis of melioidosis pneumonia in Myanmar.
1,564 studies on the registry are indexed under Pneumonia; 265 are open to participants now.
This study's enrollment of 300 is above the median of 252 across 535 observational studies indexed under Pneumonia.
Browse Pneumonia studies →Myanmar Oxford Clinical Research Unit is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
The population investigated will be patients attending two non-governmental organisation community clinics in the most deprived areas of Yangon, Myanmar
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Exclusion Criteria:
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Evaluation of a lateral flow assay for the detection of B.pseudomallei 6-deoxyheptan capsular polysaccharide antigen from sputum
Proportion of patients with a positive B.pseudomallei culture result
Number of patients with a positive sputum culture for B.pseudomallei expressed as a proportion of all patients
Time frame: January 2019
1) Sensitivity, specificity, positive predictive value, negative predictive value of the RDT compared to culture
Using culture as the gold-standard the performance of the lateral flow assay will be assessed
Time frame: January 2019
Proportion of patients diagnosed with tuberculosis (TB) including multidrug resistant TB
Proportion of enrolled participants with a positive GeneXpert MTB/RIF test on sputum
Time frame: January 2019
Proportion of patients diagnosed with Influenza A/B
Proportion of enrolled participants with a positive Xpert Flu test on nasopharyngeal swab
Time frame: March 2019
Ran from Jul 2018 to primary completion in Apr 2019, 8 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Myanmar Oxford Clinical Research Unit