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NCT Number: NCT03528265

Adapting LFI for Melioidosis

Towards the goal of reducing melioidosis, this study will help clinicians in Sarawak to diagnose and understand the causes and risk factors for melioidosis. The data will help the clinicians to provide faster test results and better clinical care. The investigator's laboratory efforts will supplement available diagnostics by adding a new, easier-to-use test involving lateral flow immunoassay to rapidly detect Burkholderia pseudomallei, a bacterium causing melioidosis. The study aims to study up to 400 patients with melioidosis-like symptoms who are admitted to Kapit Hospital, Sarawak, Malaysia. No participants will be enrolled from other sites. The study will also examine the demographic, behavioral and occupational risk factors associated with hospital admissions to understand any existing associations between these variables and melioidosis prevalence.

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Key information

Conditions

Melioidosis Bacterial Infections Bacterial Infections and Mycoses Burkholderia Infections Gram-Negative Bacterial Infections Infections

Age range

6 month and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kapit Hospital

Kapit, Sarawak, Malaysia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Admitted to Kapit Hospital
  • Fever more than 3 days and one or more of the following:
  • Enlarged cervical, inguinal or axillary lymph nodes (greater than 3 cm in diameter), painless adenopathy or lymphadenitis or lymph node abscesses
  • One or both sides glands involvement such as tender swelling over medial aspect of the lower eyelid of the lacrimal glands; submandibular glands, parotic glands
  • Bedside scan with splenic or liver hypoechoic lesion (less than 2cm in diameter)
  • Pneumonia not responding to 48 hours of first line antibiotics
  • One or more joint pain with swelling
  • Purplish vesicle or bullae mainly over the lower limbs, may resulting in ulcer after rupture
  • Deep seated abscess or brain abscess or genitourinary abscess or osteomyelitis
  • Severe sepsis patient with or without shock and/or with multiorgan involvement

Exclusion criteria

  • Have a clear alternative diagnosis other than melioidosis by a trained health care professional at the Kapit Hospital
  • Have already been treated for melioidosis (e.g. received antibiotics before the start of the study)
  • Are younger than 6 months of age

Treatment and study plan

Lateral flow immunoassay

Device

Biospecimens of patients with melioidosis-like symptoms will be tested with lateral flow immunoassay to detect Burkholderia pseudomallei, bacterium causing melioidosis

Primary outcomes

  1. Proportion of true positive

    Time frame: up to 5 weeks

    Proportion of true positive of Bukholderia pseudomallei using rapid diagnostic tests compared to the results of qPCR, bacterial culture and Gram stain

  2. Proportion of true negative

    Time frame: up to 5 weeks

    Proportion of true negative of Bukholderia pseudomallei using rapid diagnostic tests compared to the results of qPCR, bacterial culture and Gram stain

Secondary outcomes

  1. Statistical association between risk factors and test results

    Time frame: up to 3 months

    conduct a survey to determine a statistical association between clinical risk factors and the test results combined

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Adapting a Rapid Lateral Flow Burkholderia Pseudomallei Immunoassay in Sarawak, Malaysia

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 17, 2018
Registry last updated
Aug 1, 2019

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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