Causes of Pneumonia in Yangon

NCT03578133 | Completed

• 1 other identifier: OXTREC 19-18
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Melioidosis Pneumonia

Keywords

pneumonia; melioidosis; Myanmar; diagnosis

Outcome Measures

Primary Outcomes (2)

• 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

  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

  January 2019

Secondary Outcomes (2)

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

  January 2019

• Proportion of patients diagnosed with Influenza A/B

  March 2019

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The population investigated will be patients attending two non-governmental organisation community clinics in the most deprived areas of Yangon, Myanmar

You may qualify if:

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

You may not qualify if:

• \. Inability to provide a sputum specimen

Sponsors & Collaborators

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

Study Sites (1)

Medical Action Myanmar Clinics

Yangon, Burma

Location

Related Publications (6)

• 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.

  PMID: 27571754 BACKGROUND

• 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.

  PMID: 24651568 BACKGROUND

• 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.

  PMID: 16354832 BACKGROUND

• 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.

  PMID: 29579128 BACKGROUND

• 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.

  PMID: 29720430 BACKGROUND

• 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.

  PMID: 22970946 BACKGROUND

MeSH Terms

Conditions

Pneumonia; Melioidosis; Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Elizabeth A Ashley, Dr

  Myanmar Oxford Clinical Research Unit

  PRINCIPAL INVESTIGATOR

• Frank Smithuis, Prof

  Myanmar Oxford Clinical Research Unit and Medical Action Myanmar

  PRINCIPAL INVESTIGATOR

• Clare Warrell, Dr

  Myanmar Oxford Clinical Research Unit and Medical Action Myanmar

  STUDY DIRECTOR

• David Dance, Prof

  Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit

  STUDY DIRECTOR

• Ni Ni Tun, Dr

  Medical Action Myanmar

  STUDY DIRECTOR

• Mo Mo Win, Dr

  Department of Medical Research, Myanmar

  STUDY DIRECTOR

• Alistair McLean, Dr

  Myanmar Oxford Clinical Research Unit

  STUDY DIRECTOR

• Kyaw Soe

  Myanmar Oxford Clinical Research Unit

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2018
• First Posted: July 5, 2018
• Study Start: July 9, 2018
• Primary Completion: April 4, 2019
• Study Completion: April 4, 2019
• Last Updated: January 13, 2020

Record last verified: 2020-01

Locations

BU (1)