Study to understand genetic basis of melioidosis
- Conditions
- geneticsinfectionMelioidosisGeneticMelioidosis
- Registration Number
- TCTR20190322003
- Lead Sponsor
- niversity of Oxford
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 1135
Melioidosis patients Diabetes Cohort inclusion criteria (MD cohort)
- Age greater than or equal to 18 years
- Suspected cases of Melioidosis on Day 0 with HbA1c confirmed diabetes status.
- Willingness to participate in the study and written, informed consent obtained from the patient or their relative.
- Resident in North East Thailand for at least the previous 2 years
Melioidosis patient Non-diabetes Cohort inclusion criteria (MN cohort)
- Age greater than or equal to 18 years
- Suspected cases of Melioidosis on Day 0 with HbA1c confirmed non-diabetes status.
- Willingness to participate in the study and written, informed consent obtained from the patient or their relative
- Resident in North East Thailand for at least the previous 2 years
Healthy control with Diabetes Cohort inclusion criteria (HD cohort)
- Age greater than or equal to 18 years
- Currently well or out-patient with HbA1c confirmed diabetes status
- Willingness to participate in the study and written, informed consent obtained from the participant
- Resident in North East Thailand for at least the previous 2 years
Healthy control Non-diabetes Cohort inclusion criteria (HN cohort)
- Age greater than or equal to 18 years
- Currently well with no other medical problems requiring hospital specialist supervision with HbA1c confirmed non-diabetes status
- Willingness to participate in the study and written, informed consent obtained from the participant
- Resident in North East Thailand for at least the previous 2 years
Infection control with Diabetes Cohort inclusion criteria (ID cohort)
- Age greater than or equal to 18 years
- Culture-confirmed bacteraemia of a Gram negative pathogenic bacteria other than Burkholderia pseudomallei with HbA1c confirmed diabetes status
- Willingness to participate in the study and written, informed consent obtained from the patient or their relative
- Resident in North East Thailand for at least the previous 2 years
Infection control with Non-diabetes Cohort inclusion criteria (IN cohort)
- Age greater than or equal to 18 years
- Culture-confirmed bacteraemia of a Gram negative pathogenic bacteria other than Burkholderia pseudomallei with HbA1c confirmed non-diabetes status
- Willingness to participate in the study and written, informed consent obtained from the patient or their relative
- Resident in North East Thailand for at least the previous 2 years
Melioidosis Cohort (including diabetic and non-diabetic) exclusion criteria:
- Current TB or treatment of TB within the last 6 months
Documented HIV infection, chemotherapy, or other immunosuppressant therapy in the last 12 months.
- Pregnancy
Healthy Cohort (including diabetic and non-diabetic) exclusion criteria:
- Previous history of melioidosis
- Significant acute intercurrent illness
- Current TB or treatment of TB within the last 6 months
- Documented HIV infection, chemotherapy, or other immunosuppressant therapy in the last 12 months
- Pregnancy
Gram Negative bacteraemia (including diabetic and non-diabetic) exclusion criteria:
- Previous history of melioidosis
- Current TB or treatment of TB within the last 6 months
- Documented HIV infection, chemotherapy, or other immunosuppressant therapy in the last 12 months
- Pregnancy
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Bacteria that associated with melioidosis severity and variable disease outcomes single time point at patient admission Summary statistics of bacterial genetic factors,Patient biomarkers that associated with melioidosis severity and variable disease outcomes single time point at patient admission Summary statistics of host biomarkers
- Secondary Outcome Measures
Name Time Method host diabetic status modulate the effect of the bacterial in disease single time point at patient admission Summary statistics of bacterial genetic factors being modulated by host diabetic status,host diabetic status modulate the effect of the patient biomarkers in disease single time point at patient admission Summary statistics of host biomarkers being modulated by host diabetic status