An observational study in Melioidosis, sponsored by University of Oxford. Recruiting at 3 sites in 3 countries. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by University of Oxford · Observational
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
This is a longitudinal, multicentre observational study conducted across three established microbiology units integrated within hospital and community health systems:
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.
University of Oxford is the lead sponsor of 812 studies on the registry; 119 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Inclusion criteria for melioidosis patients:
Inclusion criteria for healthy controls:
Inclusion criteria for sandbox residents:
Exclusion criteria for melioidosis patients:
Exclusion criteria for healthy controls:
Exclusion criteria for sandbox residents
-N/A
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients confirmed to have melioidosis
Healthy controls will be enrolled for each confirmed melioidosis case. A healthy control is defined as an individual with no current fever, no evidence of soft tissue infection, and no prior history of melioidosis. Controls will be recruited within approximately two weeks of case identification and will be matched to cases by age (±5 years), sex, and village of residence.
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.
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
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
Plan to share: Yes — The study outputs, including genomic and transcriptomic data and associated metadata, will be valuable for future research. In compliance with the Wellcome Trust's open data policies and to encourage reproducibility, data will be deposited in two repositories: Human genomic and transcriptomic data: European Genome-Phenome Archive (EGA), under managed access Bacterial genomic data: European Nucleotide Archive (ENA), open access Pseudonymised metadata, including participant demographics and microbiological findings, will be shared with qualified researchers in accordance with the General Data Protection Regulation (GDPR). No personally identifiable information will be shared, and participants will not be identifiable from any released data.
Supporting information: Study protocol
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Melioidosis