Clinical trial NCT06089668: An Observational Study to Evaluate Clinical Characteristics of Adult Patients With Suspected or Confirmed Melioidosis
Official title: A Prospective Observational Study to Evaluate Clinical Characteristics, Current Practice and Outcomes of Adult Patients With Suspected or Confirmed Melioidosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melioidosis
Keywords: Melioidosis
Lead sponsor: AN2 Therapeutics, Inc
Sponsor class: INDUSTRY
Collaborators: name: Mahidol Oxford Tropical Medicine Research Unit
First posted: 2023-10-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients in Thailand and Laos with suspected or confirmed melioidosis

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.

Eligibility 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

Primary outcomes:
measure: Data Collection of patients in Thailand with "suspected melioidosis"
timeFrame: 2 years
measure: Data Collection of patients in Thailand with "microbiologically confirmed melioidosis ".
timeFrame: 2 years
measure: Data Collection of patients in Laos with "suspected melioidosis"
timeFrame: 2 years
measure: Data Collection of patients in Laos with "microbiologically confirmed melioidosis ".
timeFrame: 2 years
Secondary outcomes:
measure: Use ± Immunofluorescence Microscopy (IFM) to Determine the percentage of "suspected melioidosis patients" with microbiologically confirmed disease
timeFrame: 2 Years
measure: Use ± Polymerase Chain Reaction (PCR) to Determine the percentage of "suspected melioidosis patients" with microbiologically confirmed disease
timeFrame: 2 Years
measure: Determine the rates of Burkholderia pseudomallei eradication in patients with microbiologically confirmed acute melioidosis
timeFrame: 28 days after enrollment
measure: Determine frequency of specific involvement of organ systems involvement in patients with microbiologically confirmed acute melioidosis
timeFrame: 28 days after enrollment
measure: Measure rate to resolution of bacteremia conversion to negative cultures
timeFrame: 28 days after enrollment
measure: Measure time to resolution of bacteremia conversion to negative cultures
timeFrame: 28 days after enrollment
measure: Frequency of Liver involvement in patients with microbiologically confirmed acute melioidosis (as diagnosed per standard of care)
timeFrame: 28 days after enrollment
measure: Frequency of Skin involvement in patients with microbiologically confirmed acute melioidosis (as diagnosed per standard of care)
timeFrame: 28 days after enrollment
measure: Frequency of Lung involvement in patients with microbiologically confirmed acute melioidosis (as diagnosed per standard of care)
timeFrame: 28 days after enrollment
measure: Frequency of Spleen involvement in patients with microbiologically confirmed acute melioidosis (as diagnosed per standard of care)
timeFrame: 28 days after enrollment
measure: Time to resolution of sepsis
timeFrame: enrollment through day 90
measure: Time to resolution of fever
timeFrame: enrollment through day 90
measure: Time to resolution of hypotension
timeFrame: enrollment through day 90
measure: Determine clinical cure rates among patients with of microbiologically confirmed acute melioidosis who are treated with ceftazidime
timeFrame: enrollment through day 90
measure: Determine clinical cure rates among patients with microbiologically confirmed acute melioidosis who are treated with meropenem
timeFrame: enrollment through day 90
measure: Determine clinical cure rates among patients with suspected melioidosis who are treated with an appropriate antibiotic in the subset of patients with no other microbiologically confirmed diagnosis
timeFrame: enrollment through day 90
measure: Antimicrobial durations of treatment of microbiologically confirmed acute melioidosis
timeFrame: enrollment through day 90
Other outcomes:
Locations:
city: Vientiane
country: Lao People's Democratic Republic
facility: Mahosot Hospital
city: Khon Kaen
country: Thailand
facility: Srinagarind Hospital
city: Ubon Ratchathani
country: Thailand
facility: Sunpasitthiprasong Hospital
Study officials:
References: