Status:
COMPLETED
An Observational Study to Evaluate Clinical Characteristics of Adult Patients With Suspected or Confirmed Melioidosis
Lead Sponsor:
AN2 Therapeutics, Inc
Collaborating Sponsors:
Mahidol Oxford Tropical Medicine Research Unit
Conditions:
Melioidosis
Eligibility:
All Genders
18+ years
Brief 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.
Detailed Description
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. Determination o...
Eligibility Criteria
Inclusion
- 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 \[e.g. r/o infectious disease, r/o malaria, r/o dengue, r/o bacteraemia and r/o leptospirosis\])
- 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
- For Melioidosis-suspected Group ONLY
- 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
Key Trial Info
Start Date :
November 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 2 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06089668
Start Date
November 1 2023
End Date
February 2 2025
Last Update
May 31 2025
Active Locations (3)
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1
Mahosot Hospital
Vientiane, Laos, Laos
2
Srinagarind Hospital
Khon Kaen, Thailand, 40002
3
Sunpasitthiprasong Hospital
Ubon Ratchathani, Thailand, 34000