Decoding the Triad: the Interplay Between Environment, Pathogen, and Host in Melioidosis (DeEPH)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,400
- 试验地点
- 6
- 主要终点
- Development of melioidosis following exposure, assessed among melioidosis cases
研究概览
简要总结
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
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
结局指标
主要结局
Development of melioidosis following exposure, assessed among melioidosis cases
时间窗: 365 days
Development of melioidosis following exposure, assessed among healthy controls
时间窗: 365 days
Development of melioidosis following exposure, assessed among Sandbox Village residents
时间窗: 3.5 years
Mortality during the acute phase of infection among individuals with melioidosis (melioidosis cases).
时间窗: 365 days
Number of hospital readmissions following discharge among individuals with melioidosis (melioidosis cases).
时间窗: 365 days
次要结局
- 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)