CompletedNot Applicable

An Observational Study to Evaluate Clinical Characteristics of Adult Patients With Suspected or Confirmed Melioidosis

Laos, Thailand200 participantsStarted 2023-11-01

Plain-language summary

This is a prospective observational study to evaluate clinical characteristics, current practice and outcomes of adult patients (age ≥18 years) with suspected or confirmed melioidosis.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Males and females 18 years old and greater.
. Thai and Laos nationality (for study site in Thailand and Laos, respectively).
. Required hospitalization
. Community-acquired infection is suspected as the cause of illness (Related terms - e.g. fever, acute fever, community-acquired sepsis, and other infectious diseases \[e.g. r/o infectious disease, r/o malaria, r/o dengue, r/o bacteraemia and r/o leptospirosis\])

Exclusion criteria

. Have confirmed diagnosis of other infectious diseases (e.g. malaria, dengue, leptospirosis) at screening based on rapid diagnostic tests or confirmatory diagnostic tests
. Non-infectious disease (e.g. stroke, heart attack) is suspected to be a primary cause of the sepsis or shock
. Hospital-acquired infection is suspected by attending physician as the cause of illness

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Data Collection of patients in Thailand with "suspected melioidosis"

Timeframe: 2 years

Data Collection of patients in Thailand with "microbiologically confirmed melioidosis ".

Timeframe: 2 years

Data Collection of patients in Laos with "suspected melioidosis"

Timeframe: 2 years

Data Collection of patients in Laos with "microbiologically confirmed melioidosis ".

Timeframe: 2 years

Trial details

NCT IDNCT06089668

SponsorAN2 Therapeutics, Inc

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-10-31

View on ClinicalTrials.gov More Melioidosis trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Males and females 18 years old and greater.
. Thai and Laos nationality (for study site in Thailand and Laos, respectively).
. Required hospitalization
. Community-acquired infection is suspected as the cause of illness (Related terms - e.g. fever, acute fever, community-acquired sepsis, and other infectious diseases \[e.g. r/o infectious disease, r/o malaria, r/o dengue, r/o bacteraemia and r/o leptospirosis\])

Exclusion criteria

. Have confirmed diagnosis of other infectious diseases (e.g. malaria, dengue, leptospirosis) at screening based on rapid diagnostic tests or confirmatory diagnostic tests
. Non-infectious disease (e.g. stroke, heart attack) is suspected to be a primary cause of the sepsis or shock
. Hospital-acquired infection is suspected by attending physician as the cause of illness

What they're measuring

Data Collection of patients in Thailand with "suspected melioidosis"

Timeframe: 2 years

Data Collection of patients in Thailand with "microbiologically confirmed melioidosis ".

Timeframe: 2 years

Data Collection of patients in Laos with "suspected melioidosis"

Timeframe: 2 years

Data Collection of patients in Laos with "microbiologically confirmed melioidosis ".

Timeframe: 2 years