Environment, Pathogens, and Host Interactions in Melioidosis
ConditionMelioidosis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20+
SponsorUniversity of Oxford
About this trial
This is a longitudinal, multicentre observational study conducted across three established microbiology units integrated within hospital and community health systems in Thailand, Lao PDR, and Cambodia.
The hospital cohort will enroll approximately1,000 patients with positive melioidosis. Participants will be followed at six time points from admission through one year (post-discharge) to capture acute and recovery-phase outcomes, with clinical data collected on demographics, comorbidities, exposures, treatment, adherence, and outcomes.
For each confirmed case, a healthy control will be recruited within two weeks and matched by age, sex, and village of residence. Controls with no symptoms or history of melioidosis will provide a single blood sample at enrolment and will be followed by telephone at 6 and 12 months.
In addition to hospital-based surveillance, a high-risk community in northern Ubon Ratchathani-referred to as the Sandbox Village-will be intensively monitored to capture subclinical infections and to assess environmental factors influencing disease acquisition.
This study is funded by the Wellcome Trust. The grant reference number is 323077/Z/24/Z
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age ≥20 years
Positive for Burkholderia pseudomallei from any clinical samples
Resident of the study area for at least two years, including the follow-up period
Willing to participate and give informed consent.
Disqualifiers
Current tuberculosis (TB) or TB treatment within the past six months
Documented HIV infection or use of immunosuppressive therapy in the past 12 months
History of melioidosis
Significant acute illness
Trial population
Melioidosis patients: Patients confirmed to have melioidosis. Healthy controls: For each confirmed melioidosis case, a healthy control-defined as having no current fever, no evidence of soft tissue infection, and no prior history of melioidosis-will be recruited from satellite blood bank donors within approximately two weeks of case identification. Controls will be matched by age (±5 years), sex, and village of residence. Sandbox Village residents: All residents of the Sandbox Village, a high-risk area for melioidosis, will be enrolled to monitor disease progression and to evaluate the impact of improved water sanitation.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
2,400 Participants
are grouped into 3 trial groupsGroup A: Melioidosis patients
Group B: Healthy controls
Group C: Sandbox village cohort
Trial outcomes
Primary outcomes
1
Development of melioidosis following exposure, assessed among melioidosis cases
Time frame
365 days2
Development of melioidosis following exposure, assessed among healthy controls
Time frame
365 days3
Development of melioidosis following exposure, assessed among Sandbox Village residents
Time frame
3.5 years4
Mortality during the acute phase of infection among individuals with melioidosis (melioidosis cases).
Time frame
365 daysSecondary outcomes
1
Changes in disease development following exposure associated with interactions between environmental modifications.
Time frame
3.5 years2
Changes in mortality during the acute phase of infection following exposure associated with interactions between environmental modifications.
Time frame
365 days3
Changes in hospital readmission following recovery associated with interactions between environmental modifications.
Time frame
365 days4
Changes in disease development following exposure associated with interactions between clinical management factors.
Time frame
365 daysSponsors and contacts
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Source ClinicalTrials.gov
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