Ignite Creation Date:
2025-12-24 @ 5:50 PM
Ignite Modification Date:
2026-01-01 @ 3:04 PM
Study NCT ID:
NCT06089668
Status:
COMPLETED
Last Update Posted:
2025-05-31
First Post:
2023-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Observational Study to Evaluate Clinical Characteristics of Adult Patients With Suspected or Confirmed Melioidosis
Sponsor:
AN2 Therapeutics, Inc
Organization:
Study Overview
Official Title:
A Prospective Observational Study to Evaluate Clinical Characteristics, Current Practice and Outcomes of Adult Patients With Suspected or Confirmed Melioidosis
Status:
COMPLETED
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: