Adapting LFI for Melioidosis (NCT03528265) | Clinical Trial Compass
CompletedNot Applicable
Adapting LFI for Melioidosis
Malaysia100 participantsStarted 2018-06-21
Plain-language summary
Towards the goal of reducing melioidosis, this study will help clinicians in Sarawak to diagnose and understand the causes and risk factors for melioidosis. The data will help the clinicians to provide faster test results and better clinical care. The investigator's laboratory efforts will supplement available diagnostics by adding a new, easier-to-use test involving lateral flow immunoassay to rapidly detect Burkholderia pseudomallei, a bacterium causing melioidosis. The study aims to study up to 400 patients with melioidosis-like symptoms who are admitted to Kapit Hospital, Sarawak, Malaysia. No participants will be enrolled from other sites. The study will also examine the demographic, behavioral and occupational risk factors associated with hospital admissions to understand any existing associations between these variables and melioidosis prevalence.
Who can participate
Age range
6 Months
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:
* Admitted to Kapit Hospital
* Fever more than 3 days and one or more of the following:
* Enlarged cervical, inguinal or axillary lymph nodes (greater than 3 cm in diameter), painless adenopathy or lymphadenitis or lymph node abscesses
* One or both sides glands involvement such as tender swelling over medial aspect of the lower eyelid of the lacrimal glands; submandibular glands, parotic glands
* Bedside scan with splenic or liver hypoechoic lesion (less than 2cm in diameter)
* Pneumonia not responding to 48 hours of first line antibiotics
* One or more joint pain with swelling
* Purplish vesicle or bullae mainly over the lower limbs, may resulting in ulcer after rupture
* Deep seated abscess or brain abscess or genitourinary abscess or osteomyelitis
* Severe sepsis patient with or without shock and/or with multiorgan involvement
Exclusion Criteria:
* Have a clear alternative diagnosis other than melioidosis by a trained health care professional at the Kapit Hospital
* Have already been treated for melioidosis (e.g. received antibiotics before the start of the study)
* Are younger than 6 months of age
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.