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

NCT06089668 | Completed

• 1 other identifier: MEL-OB1
• Study Type: observational
• Target: 200
• Locations: 2 countries
• Sites: 3

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.

Conditions

Melioidosis

Keywords

Melioidosis

Outcome Measures

Primary Outcomes (4)

• Data Collection of patients in Thailand with "suspected melioidosis"

  Describe, prospective data collection, the presenting clinical characteristics of patients hospitalized in Thailand with "suspected melioidosis" to understand the presentation of this disease in a contemporaneous, rigorously studied cohort.

  2 years

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

  Describe, prospective data collection, the presenting clinical characteristics of patients hospitalized in Thailand with "microbiologically confirmed melioidosis " to understand the presentation of this disease in a contemporaneous, rigorously studied cohort.

  2 years

• Data Collection of patients in Laos with "suspected melioidosis"

  Describe, prospective data collection, the presenting clinical characteristics of patients hospitalized in Laos with "suspected melioidosis" to understand the presentation of this disease in a contemporaneous, rigorously studied cohort.

  2 years

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

  Describe, prospective data collection, the presenting clinical characteristics of patients hospitalized in Laos with "microbiologically confirmed melioidosis " to understand the presentation of this disease in a contemporaneous, rigorously studied cohort.

  2 years

Secondary Outcomes (17)

• Use ± Immunofluorescence Microscopy (IFM) to Determine the percentage of "suspected melioidosis patients" with microbiologically confirmed disease

  2 Years

• Use ± Polymerase Chain Reaction (PCR) to Determine the percentage of "suspected melioidosis patients" with microbiologically confirmed disease

  2 Years

• Determine the rates of Burkholderia pseudomallei eradication in patients with microbiologically confirmed acute melioidosis

  28 days after enrollment

• Determine frequency of specific involvement of organ systems involvement in patients with microbiologically confirmed acute melioidosis

  28 days after enrollment

• Measure rate to resolution of bacteremia conversion to negative cultures

  28 days after enrollment

Interventions

Observational Study OTHER

None, this is a non-interventional trial

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients in Thailand and Laos with suspected or confirmed melioidosis

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AN2 Therapeutics, Inc: lead
• Mahidol Oxford Tropical Medicine Research Unit: collaborator

Study Sites (3)

Mahosot Hospital

Vientiane, Laos, Laos

Location

Srinagarind Hospital

Khon Kaen, 40002, Thailand

Location

Sunpasitthiprasong Hospital

Ubon Ratchathani, 34000, Thailand

Location

MeSH Terms

Conditions

Melioidosis

Interventions

Observation

Condition Hierarchy (Ancestors)

Burkholderia Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2023
• First Posted: October 18, 2023
• Study Start: November 1, 2023
• Primary Completion: October 31, 2024
• Study Completion: February 2, 2025
• Last Updated: May 31, 2025

Record last verified: 2025-05

Locations

TH (2); LA (1)