NCT06089668

An Observational Study to Evaluate Clinical Characteristics of Adult Patients 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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: AN2 Therapeutics, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 of microbiologically confirmed acute melioidosis among patients presenting with suspected melioidosis, and determination of clinical outcomes of interest (including all-cause mortality, characterization of organ involvement or organ failure, resolution of sepsis, improvement of renal function, rates of suspected vs. microbiologically confirmed melioidosis, and rates of melioidosis involvement of different organ systems) will be performed. Defining clinical and microbiological outcomes in a standardized manner will enable characterization and selection of the relevant outcome measures to be utilized in future clinical studies of IV epetraborole in acute melioidosis. Patients will be identified through daily, active surveillance of hospital admissions at the investigative sites and review of microbiology laboratory culture results. Data will be extracted from hospital and outpatient medical charts. These data will refine the expected treatment effect of standard-of-care antimicrobial therapy and the consequent statistical power calculations needed for sample size and outcome measure design elements of future clinical trials of IV epetraborole adjunctive therapy in hospitalized patients with suspected acute melioidosis. Participation in the study requires written informed consent from the patient or from their next-of-kin (if needed) at the time of screening. On day 28 (+7) and day 90 (+7) after enrolment the study team will contact the participant by phone interview with standardized script if the participant is discharged alive prior to the day 28 or day 90. There will be no clinical specimens collected as part of the study protocol, as this study aims to observe clinical characteristics and outcomes among patients with confirmed and suspected acute melioidosis in current clinical practice.

Conditions

• Melioidosis

Interventions

Type	Name	Description
OTHER	Observational Study	None, this is a non-interventional trial

Timeline

• Start date: 2023-11-01
• Primary completion: 2024-10-31
• Completion: 2025-02-02
• First posted: 2023-10-18
• Last updated: 2025-05-31

Locations

3 sites across 2 countries: Laos, Thailand