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Completed

NCT Number: NCT03578133

Causes of Pneumonia in Yangon

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

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Key information

Conditions

Melioidosis Pneumonia Bacterial Infections Bacterial Infections and Mycoses Burkholderia Infections Disease Gram-Negative Bacterial Infections Infections Lung Diseases Melioidosis Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical Action Myanmar Clinics

Yangon, Burma

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • >18 years old
  • Reported fever or axillary temperature > 37.5 °C
  • Productive cough
  • Written informed consent

Exclusion criteria

  • Inability to provide a sputum specimen

Treatment and study plan

InBios® Active Melioidosis DetectTM-Lateral Flow Assay

Diagnostic Test

Evaluation of a lateral flow assay for the detection of B.pseudomallei 6-deoxyheptan capsular polysaccharide antigen from sputum

Primary outcomes

  1. Proportion of patients with a positive B.pseudomallei culture result

    Time frame: January 2019

    Number of patients with a positive sputum culture for B.pseudomallei expressed as a proportion of all patients

  2. 1) Sensitivity, specificity, positive predictive value, negative predictive value of the RDT compared to culture

    Time frame: January 2019

    Using culture as the gold-standard the performance of the lateral flow assay will be assessed

Secondary outcomes

  1. Proportion of patients diagnosed with tuberculosis (TB) including multidrug resistant TB

    Time frame: January 2019

    Proportion of enrolled participants with a positive GeneXpert MTB/RIF test on sputum

  2. Proportion of patients diagnosed with Influenza A/B

    Time frame: March 2019

    Proportion of enrolled participants with a positive Xpert Flu test on nasopharyngeal swab

Sponsors and collaborators

Lead sponsor

Myanmar Oxford Clinical Research Unit

Other

Collaborators

  • Department of Medical Research, Myanmar
  • Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit
  • Medical Action Myanmar

Registry information

Official study title

A Cross-sectional Study Investigating the Causes of Pneumonia in Two Community Clinics in Two Yangon Townships, Myanmar

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 5, 2018
Registry last updated
Jan 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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