Melioidosis PneumoniaNCT03578133
Causes of Pneumonia in Yangon
An observational study of Melioidosis Pneumonia, run by Myanmar Oxford Clinical Research Unit at 1 site in Burma.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melioidosis Pneumonia
- What is being tested?
- InBios® Active Melioidosis DetectTM-Lateral Flow Assay
- How many people
- 300 participants
- Where
- 1 siteBurma
- Study dates
- 9 Jul 2018to 4 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population investigated will be patients attending two non-governmental organisation community clinics in the most deprived areas of Yangon, Myanmar
Who may be able to join
- >18 years old
- Reported fever or axillary temperature > 37.5 °C
- Productive cough
- Written informed consent
Who cannot join
- 1. Inability to provide a sputum specimen
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Cross-sectional Study Investigating the Causes of Pneumonia in Two Community Clinics in Two Yangon Townships, Myanmar
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
Read the detailed description
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.
- Conditions
- Melioidosis Pneumonia
- Being tested
- InBios® Active Melioidosis DetectTM-Lateral Flow Assay
- Keywords
- pneumonia, melioidosis, Myanmar, diagnosis
- Medical subject headings
- Pneumonia, Melioidosis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InBios® Active Melioidosis DetectTM-Lateral Flow AssayDiagnostic test
Evaluation of a lateral flow assay for the detection of B.pseudomallei 6-deoxyheptan capsular polysaccharide antigen from sputum
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: January 2019
Secondary outcomes (2)
Proportion of patients diagnosed with tuberculosis (TB) including multidrug resistant TB
Proportion of enrolled participants with a positive GeneXpert MTB/RIF test on sputum
Measured: January 2019
Proportion of patients diagnosed with Influenza A/B
Proportion of enrolled participants with a positive Xpert Flu test on nasopharyngeal swab
Measured: March 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2018
- Study start9 Jul 2018
- Primary completion4 Apr 2019
- Study completion4 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Melioidosis PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Myanmar Oxford Clinical Research Unit
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Action Myanmar, Department of Medical Research, Myanmar, Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit
- Responsible party
- Sponsor
- Investigators
- Elizabeth A Ashley, Dr, Principal investigator, Myanmar Oxford Clinical Research UnitFrank Smithuis, Prof, Principal investigator, Myanmar Oxford Clinical Research Unit and Medical Action MyanmarClare Warrell, Dr, Study director, Myanmar Oxford Clinical Research Unit and Medical Action MyanmarDavid Dance, Prof, Study director, Lao-Oxford-Mahosot Hospital Wellcome Trust Research UnitNi Ni Tun, Dr, Study director, Medical Action MyanmarMo Mo Win, Dr, Study director, Department of Medical Research, MyanmarAlistair McLean, Dr, Study director, Myanmar Oxford Clinical Research UnitKyaw Soe, Study director, Myanmar Oxford Clinical Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03578133
- Sponsor's protocol ID
- OXTREC 19-18
- Status last verified
- Jan 2020
- First submitted
- 24 Jun 2018
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27571754Houghton 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.
PubMed 24651568Chierakul 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.
PubMed 16354832Shaw 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.
PubMed 29579128Woods 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.
PubMed 29720430Wiersinga WJ, Currie BJ, Peacock SJ. Melioidosis. N Engl J Med. 2012 Sep 13;367(11):1035-44. doi: 10.1056/NEJMra1204699. No abstract available.
PubMed 22970946
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-sectional Study Investigating the Causes of Pneumonia in Two Community Clinics in Two Yangon Townships, Myanmar
- ClinicalTrials.gov ID
- NCT03578133
- Acronym / sponsor ID
- OXTREC 19-18
- Conditions
- Melioidosis Pneumonia
- Keywords
- pneumonia, melioidosis, Myanmar, diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Myanmar Oxford Clinical Research UnitUniversity, hospital or other
- Collaborators
- Medical Action Myanmar, Department of Medical Research, Myanmar, Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit
- Study start
- 9 Jul 2018 (actual)
- Primary completion
- 4 Apr 2019 (actual)
- Study completion
- 4 Apr 2019 (actual)
- First posted
- 5 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population investigated will be patients attending two non-governmental organisation community clinics in the most deprived areas of Yangon, Myanmar
Key inclusion criteria (4 listed)
- >18 years old
- Reported fever or axillary temperature > 37.5 °C
- Productive cough
- Written informed consent
Key exclusion criteria (1 listed)
- 1. Inability to provide a sputum specimen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InBios® Active Melioidosis DetectTM-Lateral Flow AssayEvaluation of a lateral flow assay for the detection of B.pseudomallei 6-deoxyheptan capsular polysaccharide antigen from sputum | Diagnostic test | – |
Primary outcome
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
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
2 secondary outcomes
Proportion of patients diagnosed with tuberculosis (TB) including multidrug resistant TB
Time frame: January 2019
Proportion of patients diagnosed with Influenza A/B
Time frame: March 2019
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Background: PubMed 27571754Limmathurotsakul 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.
- Background: PubMed 24651568Houghton 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.
- Background: PubMed 16354832Chierakul 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.
- Background: PubMed 29579128Shaw 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.
- Background: PubMed 29720430Woods 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.
- Background: PubMed 22970946Wiersinga WJ, Currie BJ, Peacock SJ. Melioidosis. N Engl J Med. 2012 Sep 13;367(11):1035-44. doi: 10.1056/NEJMra1204699. No abstract available.
Related trials for Melioidosis Pneumonia
RecruitingObservational study
Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective
Dengue, Chikungunya
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth A Ashley, Dr principal investigator
Myanmar Oxford Clinical Research Unit
Frank Smithuis, Prof principal investigator
Myanmar Oxford Clinical Research Unit and Medical Action Myanmar
Clare Warrell, Dr study director
Myanmar Oxford Clinical Research Unit and Medical Action Myanmar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melioidosis Pneumonia, run by Myanmar Oxford Clinical Research Unit at 1 site in Burma.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Burma. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with a positive B.pseudomallei culture result (time frame: January 2019). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03578133, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020.