Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
300 participants
OBSERVATIONAL
2018-07-09
2019-04-04
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Prospective Clinical Evaluation of the FilmArray Respiratory Panel 2
NCT03012217
The Establishment and Improvement of Community Acquired Pneumonia Monitoring and Disposal Network in Beijing
NCT01236677
The Oxford Pleural Infection Endotyping Study
NCT06513689
Environment, Pathogens, and Host Interactions in Melioidosis
NCT07345910
Innate Immune Response of Blood Cells in Patients With Pneumonia
NCT03231670
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
CROSS_SECTIONAL
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
InBios® Active Melioidosis DetectTM-Lateral Flow Assay
Evaluation of a lateral flow assay for the detection of B.pseudomallei 6-deoxyheptan capsular polysaccharide antigen from sputum
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Reported fever or axillary temperature \> 37.5 °C
3. Productive cough
4. Written informed consent
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medical Action Myanmar
OTHER
Department of Medical Research, Myanmar
UNKNOWN
Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit
OTHER
Myanmar Oxford Clinical Research Unit
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Elizabeth A Ashley, Dr
Role: PRINCIPAL_INVESTIGATOR
Myanmar Oxford Clinical Research Unit
Frank Smithuis, Prof
Role: PRINCIPAL_INVESTIGATOR
Myanmar Oxford Clinical Research Unit and Medical Action Myanmar
Clare Warrell, Dr
Role: STUDY_DIRECTOR
Myanmar Oxford Clinical Research Unit and Medical Action Myanmar
David Dance, Prof
Role: STUDY_DIRECTOR
Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit
Ni Ni Tun, Dr
Role: STUDY_DIRECTOR
Medical Action Myanmar
Mo Mo Win, Dr
Role: STUDY_DIRECTOR
Department of Medical Research, Myanmar
Alistair McLean, Dr
Role: STUDY_DIRECTOR
Myanmar Oxford Clinical Research Unit
Kyaw Soe
Role: STUDY_DIRECTOR
Myanmar Oxford Clinical Research Unit
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Medical Action Myanmar Clinics
Yangon, , Burma
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Limmathurotsakul D, Golding N, Dance DA, Messina JP, Pigott DM, Moyes CL, Rolim DB, Bertherat E, Day NP, Peacock SJ, Hay SI. Predicted global distribution of Burkholderia pseudomallei and burden of melioidosis. Nat Microbiol. 2016 Jan 11;1:15008. doi: 10.1038/nmicrobiol.2015.8.
Houghton RL, Reed DE, Hubbard MA, Dillon MJ, Chen H, Currie BJ, Mayo M, Sarovich DS, Theobald V, Limmathurotsakul D, Wongsuvan G, Chantratita N, Peacock SJ, Hoffmaster AR, Duval B, Brett PJ, Burtnick MN, Aucoin DP. Development of a prototype lateral flow immunoassay (LFI) for the rapid diagnosis of melioidosis. PLoS Negl Trop Dis. 2014 Mar 20;8(3):e2727. doi: 10.1371/journal.pntd.0002727. eCollection 2014 Mar.
Chierakul W, Wuthiekanun V, Chaowagul W, Amornchai P, Cheng AC, White NJ, Day NP, Peacock SJ. Short report: disease severity and outcome of melioidosis in HIV coinfected individuals. Am J Trop Med Hyg. 2005 Dec;73(6):1165-6.
Shaw T, Tellapragada C, Ke V, AuCoin DP, Mukhopadhyay C. Performance evaluation of Active Melioidosis Detect-Lateral Flow Assay (AMD-LFA) for diagnosis of melioidosis in endemic settings with limited resources. PLoS One. 2018 Mar 26;13(3):e0194595. doi: 10.1371/journal.pone.0194595. eCollection 2018.
Woods KL, Boutthasavong L, NicFhogartaigh C, Lee SJ, Davong V, AuCoin DP, Dance DAB. Evaluation of a Rapid Diagnostic Test for Detection of Burkholderia pseudomallei in the Lao People's Democratic Republic. J Clin Microbiol. 2018 Jun 25;56(7):e02002-17. doi: 10.1128/JCM.02002-17. Print 2018 Jul.
Wiersinga WJ, Currie BJ, Peacock SJ. Melioidosis. N Engl J Med. 2012 Sep 13;367(11):1035-44. doi: 10.1056/NEJMra1204699. No abstract available.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
OXTREC 19-18
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.