MelioidosisDeEPHNCT07345910
Environment, Pathogens, and Host Interactions in Melioidosis
An observational study of Melioidosis, run by University of Oxford at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Melioidosis
- How many people
- 2,400 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 19 Aug 2026to 1 Dec 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
- Age ≥20 years
- Currently healthy as judged by study doctor
Show all 11Show fewer
- Resident of the study area for at least two years, including the follow-up period
- Willing to participate and give informed consent.
- 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.
Who cannot join
- 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
- Current fever or soft tissue infection
- -N/A
Trial locations and contacts
3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 3 countries
Cambodia1 site, 1 recruiting
- Not yet recruiting
Cambodia-Oxford Medical Research Unit (COMRU)
Siem Reap
Paul Turner, MD, Pault@tropmedres.ac
Laos1 site, 1 recruiting
- Not yet recruiting
Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit (LOMWRU)
Vientiane
Elizabeth Ashley, MD, Elizabeth.Ashley@tropmedres.ac
Thailand1 site, 1 recruiting
- Recruiting
Sunpasitthiprosong Hospital
Ubon Ratchathani
Kamolchanok C Chewapreecha, PhD, 022036333, claire@tropmedres.ac
About this study
Official title: Decoding the Triad: the Interplay Between Environment, Pathogen, and Host in Melioidosis (DeEPH)
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.
Read more
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
Read the 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.
- Conditions
- Melioidosis
- Medical subject headings
- Melioidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Melioidosis patients | Patients confirmed to have melioidosis | |
| Healthy controls | 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. | |
| Sandbox village cohort | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of melioidosis following exposure, assessed among melioidosis cases
Measured: 365 days
Development of melioidosis following exposure, assessed among healthy controls
Measured: 365 days
Development of melioidosis following exposure, assessed among Sandbox Village residents
Measured: 3.5 years
Mortality during the acute phase of infection among individuals with melioidosis (melioidosis cases).
Measured: 365 days
Number of hospital readmissions following discharge among individuals with melioidosis (melioidosis cases).
Measured: 365 days
Secondary outcomes (9)
Changes in disease development following exposure associated with interactions between environmental modifications.
Measured: 3.5 years
Changes in mortality during the acute phase of infection following exposure associated with interactions between environmental modifications.
Measured: 365 days
Changes in hospital readmission following recovery associated with interactions between environmental modifications.
Measured: 365 days
Changes in disease development following exposure associated with interactions between clinical management factors.
Measured: 365 days
Changes in mortality during the acute phase of infection following exposure associated with interactions between clinical management factors.
Measured: 365 days
Changes in hospital readmission following recovery associated with interactions between clinical management factors.
Measured: 365 days
Changes in disease development following exposure associated with interactions involving genetic susceptibility.
Measured: 365 days
Changes in mortality during the acute phase of infection following exposure associated with interactions involving genetic susceptibility.
Measured: 365 days
Changes in hospital readmission following recovery associated with interactions involving genetic susceptibility.
Measured: 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start19 Aug 2026
- Primary completion1 Dec 2034 (estimated)
- Study completion1 Dec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelioidosisStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kamolchanok Claire Chewapreecha, PhD, Principal investigator, Mahidol Oxford Tropical Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07345910
- Sponsor's protocol ID
- MEL25001
- Acronym
- DeEPH
- Status last verified
- Sep 2026
- First submitted
- 7 Jan 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decoding the Triad: the Interplay Between Environment, Pathogen, and Host in Melioidosis (DeEPH)
- ClinicalTrials.gov ID
- NCT07345910
- Acronym / sponsor ID
- DeEPH / MEL25001
- Conditions
- Melioidosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 19 Aug 2026 (actual)
- Primary completion
- 1 Dec 2034 (estimated)
- Study completion
- 1 Dec 2034 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Melioidosis patients | – | –Patients confirmed to have melioidosis |
| Healthy controls | – | –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. |
| Sandbox village cohort | – | –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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (11 listed)
- 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.
- Age ≥20 years
Key exclusion criteria (6 listed)
- 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
- Current fever or soft tissue infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kamolchanok Claire Chewapreecha, PhD principal investigator
Mahidol Oxford Tropical Research Unit
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melioidosis, run by University of Oxford at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Cambodia, Laos, Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kamolchanok Claire Chewapreecha, PhD (662 203 6333, claire@tropmedres.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of melioidosis following exposure, assessed among melioidosis cases (time frame: 365 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.