Environment, Pathogens, and Host Interactions in Melioidosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Melioidosis. Basic parameters: from 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Cambodia, Laos, Thailand
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Decoding the Triad: the Interplay Between Environment, Pathogen, and Host in Melioidosis (DeEPH)
Overview
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
Detailed description
This is a longitudinal, multicentre observational study conducted across three established microbiology units integrated within hospital and community health systems:
* Sunpasitthiprasong Hospital, Ubon Ratchathani, Thailand (MORU); * Mahosot Hospital, Vientiane, Lao PDR (LOMWRU); and * Angkor Hospital for Children, Siem Reap, Cambodia (COMRU).
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.
Participant Recruitment and Follow-up
Hospital cohort:
Patients with melioidosis will be recruited at all three hospital sites. The study plans to recruit 1,000 patients, who will be followed longitudinally at six time points: Day 0 (admission), Days 3 and 7 (acute phase), and Days 30, 180, and 365 (recovery phase).
Clinical data collected will include demographic characteristics, underlying comorbidities, environmental exposures, lifestyle and behavioural factors, treatment history, patient-reported medication adherence, and follow-up outcomes.
Healthy controls:
Each patient will be matched with a healthy control recruited within two weeks of diagnosis, based on age, sex, and village of residence. Controls will have no current symptoms or prior history of melioidosis. They will provide a single blood sample at enrolment for DNA extraction and antibody profiling and will be followed up by telephone on Days 180 and 365.
Community cohort:
To complement hospital-based data and to identify subclinical infections, intensive community surveillance will be conducted in the Sandbox Village, a high-incidence area within the Ubon Ratchathani region. All residents (approximately 400 individuals) will be enrolled. DNA samples will be collected at baseline, and serum samples will be obtained every two months over a 42-month period, either at participants' homes or at a central village location, to measure antibody responses to Burkholderia pseudomallei as a proxy for exposure.
Community cohort:
To complement hospital-based data and to identify subclinical infections, intensive community surveillance will be conducted in the Sandbox Village, a high-incidence area within the Ubon Ratchathani region. All residents (approximately 400 individuals) will be enrolled. DNA samples will be collected at baseline, and serum samples will be obtained every two months over a 42-month period, either at participants' homes or at a central village location, to measure antibody responses to Burkholderia pseudomallei as a proxy for exposure.
Primary outcome measures
- Development of melioidosis following exposure, assessed among melioidosis cases [Time frame: 365 days]
- Development of melioidosis following exposure, assessed among healthy controls [Time frame: 365 days]
- Development of melioidosis following exposure, assessed among Sandbox Village residents [Time frame: 3.5 years]
- Mortality during the acute phase of infection among individuals with melioidosis (melioidosis cases). [Time frame: 365 days]
- Number of hospital readmissions following discharge among individuals with melioidosis (melioidosis cases). [Time frame: 365 days]
Secondary outcome measures (9)
- Changes in disease development following exposure associated with interactions between environmental modifications. [Time frame: 3.5 years]
- Changes in mortality during the acute phase of infection following exposure associated with interactions between environmental modifications. [Time frame: 365 days]
- Changes in hospital readmission following recovery associated with interactions between environmental modifications. [Time frame: 365 days]
- Changes in disease development following exposure associated with interactions between clinical management factors. [Time frame: 365 days]
- Changes in mortality during the acute phase of infection following exposure associated with interactions between clinical management factors. [Time frame: 365 days]
- Changes in hospital readmission following recovery associated with interactions between clinical management factors. [Time frame: 365 days]
- Changes in disease development following exposure associated with interactions involving genetic susceptibility. [Time frame: 365 days]
- Changes in mortality during the acute phase of infection following exposure associated with interactions involving genetic susceptibility. [Time frame: 365 days]
- Changes in hospital readmission following recovery associated with interactions involving genetic susceptibility. [Time frame: 365 days]
Eligibility criteria
Inclusion criteria for melioidosis patients:
- 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.
Inclusion criteria for healthy controls:
- Age ≥20 years
- Currently healthy as judged by study doctor
- Resident of the study area for at least two years, including the follow-up period
- Willing to participate and give informed consent.
Inclusion criteria for sandbox residents:
- Age ≥20 years
- Resident of the study area for at least two years, including the follow-up period
- Willing to participate and give informed consent.
Exclusion criteria for melioidosis patients:
- Current tuberculosis (TB) or TB treatment within the past six months
- Documented HIV infection or use of immunosuppressive therapy in the past 12 months
Exclusion criteria for healthy controls:
- History of melioidosis
- Significant acute illness
- Current fever or soft tissue infection
Exclusion criteria for sandbox residents
-N/A
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Cambodia · 1 center
- Cambodia-Oxford Medical Research Unit (COMRU) — Siem Reap
Laos · 1 center
- Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit (LOMWRU) — Vientiane
Thailand · 1 center
- Sunpasitthiprosong Hospital — Ubon Ratchathani
Identifiers
NCT: NCT07345910 · MEL25001