Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:50 PM
Ignite Modification Date:
2025-12-24 @ 5:50 PM
NCT ID:
NCT06089668
Eligibility Criteria:
Inclusion Criteria:
1. Males and females 18 years old and greater.
2. Thai and Laos nationality (for study site in Thailand and Laos, respectively).
3. Required hospitalization
4. Community-acquired infection is suspected as the cause of illness (Related terms - e.g. fever, acute fever, community-acquired sepsis, and other infectious diseases \[e.g. r/o infectious disease, r/o malaria, r/o dengue, r/o bacteraemia and r/o leptospirosis\])
For melioidosis-suspected group ONLY 4a. Community-acquired infection is suspected as the cause of illness (Related terms - e.g. fever, acute fever, community-acquired sepsis, and r/o other infectious diseases \[e.g. r/o infectious disease, r/o malaria, r/o dengue, r/o bacteraemia and r/o leptospirosis\]) 5a. Hospitalized (at study hospital) for less than 24 hours 6a. Suspected of melioidosis (at least one of the following)
* Ceftazidime or Meropenem has already been prescribed BEFORE screening
* SEPTIC SHOCK (sepsis at screening is defined as SOFA≥2 or qSOFA≥1; and shock at screening is defined as requiring vasopressor to maintain MAP≥65 mmHg)
* SEPSIS (defined as SOFA≥2 or qSOFA≥1) with AN UNDERLYING DISEASE of diabetes, chronic kidney disease, major thalassemia, cancer or on immunosuppressive drug (including steroid)
For melioidosis-confirmed group ONLY 4b. Have any specimen culture or Immunofluorescence Microscopy (IFM) or Polymerase Chain Reaction (PCR) positive for B. pseudomallei 5b. Patient is still in the study hospital (i.e. alive) on the screening day
Exclusion Criteria:
For Melioidosis-suspected Group ONLY
1. Have confirmed diagnosis of other infectious diseases (e.g. malaria, dengue, leptospirosis) at screening based on rapid diagnostic tests or confirmatory diagnostic tests
2. Non-infectious disease (e.g. stroke, heart attack) is suspected to be a primary cause of the sepsis or shock
3. Hospital-acquired infection is suspected by attending physician as the cause of illness
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06089668
Study Brief:
Protocol Section:
NCT06089668