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Environment, Pathogens, and Host Interactions in Melioidosis

Decoding the Triad: the Interplay Between Environment, Pathogen, and Host in Melioidosis (DeEPH)

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07345910
Acronym
DeEPH
Enrollment
2400
Registered
2026-01-16
Start date
2026-08-01
Completion date
2034-12-01
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melioidosis

Brief summary

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.

Interventions

None listed

Sponsors

University of Oxford
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Development of melioidosis following exposure, assessed among melioidosis cases365 days
Development of melioidosis following exposure, assessed among healthy controls365 days
Development of melioidosis following exposure, assessed among Sandbox Village residents3.5 years
Mortality during the acute phase of infection among individuals with melioidosis (melioidosis cases).365 days
Number of hospital readmissions following discharge among individuals with melioidosis (melioidosis cases).365 days

Secondary

MeasureTime frame
Changes in disease development following exposure associated with interactions between environmental modifications.3.5 years
Changes in mortality during the acute phase of infection following exposure associated with interactions between environmental modifications.365 days
Changes in hospital readmission following recovery associated with interactions between environmental modifications.365 days
Changes in disease development following exposure associated with interactions between clinical management factors.365 days
Changes in mortality during the acute phase of infection following exposure associated with interactions between clinical management factors.365 days
Changes in hospital readmission following recovery associated with interactions between clinical management factors.365 days
Changes in disease development following exposure associated with interactions involving genetic susceptibility.365 days
Changes in mortality during the acute phase of infection following exposure associated with interactions involving genetic susceptibility.365 days
Changes in hospital readmission following recovery associated with interactions involving genetic susceptibility.365 days

Countries

Cambodia, Laos, Thailand

Contacts

CONTACTKamolchanok Claire Chewapreecha, PhD
claire@tropmedres.ac662 203 6333
PRINCIPAL_INVESTIGATORKamolchanok Claire Chewapreecha, PhD

Mahidol Oxford Tropical Research Unit

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 11, 2026