Evaluating clinical characteristics of adults with suspected or confirmed melioidosis
A Prospective Observational Study to Evaluate Clinical Characteristics, Current Practice and Outcomes of Adult Patients With Suspected or Confirmed Melioidosis
This study looks at the health details and outcomes of adults with suspected or confirmed melioidosis to help improve treatment and future research.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AN2 Therapeutics, Inc Industry-sponsored |
| Locations | 3 sites (Vientiane and 2 other locations) |
| Trial ID | NCT06089668 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the clinical characteristics, current practices, and outcomes of adult patients (aged 18 and older) with suspected or confirmed melioidosis. It will involve determining microbiologically confirmed cases of acute melioidosis and assessing various clinical outcomes, including mortality rates and organ involvement. Patients will be identified through active surveillance of hospital admissions and microbiology lab results, with data extracted from medical charts. The findings will help refine treatment expectations and inform future clinical trials involving IV epetraborole for acute melioidosis.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older from Thailand and Laos who are hospitalized with suspected community-acquired infections.
Not a fit: Patients who are not hospitalized or do not have suspected melioidosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of melioidosis and improve treatment strategies for affected patients.
How similar studies have performed: While this study focuses on observational data, similar studies have shown promise in understanding infectious diseases, though the specific approach may be novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Vientiane and 2 other locations
- Mahosot Hospital — Vientiane, Lao People's Democratic Republic (Recruiting)
- Srinagarind Hospital — Khon Kaen, Thailand (Recruiting)
- Sunpasitthiprasong Hospital — Ubon Ratchathani, Thailand (Recruiting)
Study contacts
- Study coordinator: Gabrielle Khedr
- Email: gkhedr@an2therapeutics.com
- Phone: 650-331-9090
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.