Clinical trial NCT03528265: Adapting LFI for Melioidosis
Official title: Adapting a Rapid Lateral Flow Burkholderia Pseudomallei Immunoassay in Sarawak, Malaysia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melioidosis
Keywords: lateral flow immunoassay
validation
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2018-05-17
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients evaluated at Kapit Hospital experiencing melioidosis-like symptoms.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of true positive
timeFrame: up to 5 weeks
measure: Proportion of true negative
timeFrame: up to 5 weeks
Secondary outcomes:
measure: Statistical association between risk factors and test results
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Kapit
country: Malaysia
facility: Kapit Hospital
state: Sarawak
Study officials:
affiliation: Duke University
name: Gregory C Gray, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: