MelioidosisNCT06089668
An Observational Study to Evaluate Clinical Characteristics of Adult Patients With Suspected or Confirmed Melioidosis
An observational study of Melioidosis, run by AN2 Therapeutics, Inc at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melioidosis
- What is being tested?
- Observational Study
- How many people
- 200 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Nov 2023to 2 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in Thailand and Laos with suspected or confirmed melioidosis
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Thailand2 sites
Srinagarind Hospital
Khon Kaen, 40002
Sunpasitthiprasong Hospital
Ubon Ratchathani, 34000
About this study
Official title: A Prospective Observational Study to Evaluate Clinical Characteristics, Current Practice and Outcomes of Adult Patients With Suspected or Confirmed Melioidosis
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.
Read the 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
- Being tested
- Observational Study
- Keywords
- Melioidosis
- Medical subject headings
- Melioidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational StudyOther
None, this is a non-interventional trial
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 years
Secondary outcomes (17)
Use ± Immunofluorescence Microscopy (IFM) to Determine the percentage of "suspected melioidosis patients" with microbiologically confirmed disease
Use ± IFM to determine the percentage of "suspected melioidosis patients" with microbiologically confirmed disease
Measured: 2 Years
Use ± Polymerase Chain Reaction (PCR) to Determine the percentage of "suspected melioidosis patients" with microbiologically confirmed disease
Use ± PCR to determine the percentage of "suspected melioidosis patients" with microbiologically confirmed disease
Measured: 2 Years
Determine the rates of Burkholderia pseudomallei eradication in patients with microbiologically confirmed acute melioidosis
Determine microbiological eradication patients with microbiologically confirmed acute melioidosis
Measured: 28 days after enrollment
Determine frequency of specific involvement of organ systems involvement in patients with microbiologically confirmed acute melioidosis
Determine the frequency of specific organ system involvement in patients with microbiologically confirmed acute melioidosis
Measured: 28 days after enrollment
Measure rate to resolution of bacteremia conversion to negative cultures
Microbiological outcomes in patients with microbiologically confirmed acute melioidosis
Measured: 28 days after enrollment
Measure time to resolution of bacteremia conversion to negative cultures
Microbiological outcomes in patients with microbiologically confirmed acute melioidosis
Measured: 28 days after enrollment
Frequency of Liver involvement in patients with microbiologically confirmed acute melioidosis (as diagnosed per standard of care)
Frequency of involvement of organ systems in patients with microbiologically confirmed acute melioidosis
Measured: 28 days after enrollment
Frequency of Skin involvement in patients with microbiologically confirmed acute melioidosis (as diagnosed per standard of care)
Frequency of involvement of organ systems in patients with microbiologically confirmed acute melioidosis
Measured: 28 days after enrollment
Frequency of Lung involvement in patients with microbiologically confirmed acute melioidosis (as diagnosed per standard of care)
Frequency of involvement of organ systems in patients with microbiologically confirmed acute melioidosis
Measured: 28 days after enrollment
Frequency of Spleen involvement in patients with microbiologically confirmed acute melioidosis (as diagnosed per standard of care)
Frequency of involvement of organ systems in patients with microbiologically confirmed acute melioidosis
Measured: 28 days after enrollment
Time to resolution of sepsis
Time in days to resolution of sepsis in patients with microbiologically confirmed acute melioidosis who receive antimicrobial therapy directed against B. pseudomallei
Measured: enrollment through day 90
Time to resolution of fever
Time in days to resolution of fever in patients with microbiologically confirmed acute melioidosis who receive antimicrobial therapy directed against B. pseudomallei
Measured: enrollment through day 90
Time to resolution of hypotension
Time in days to resolution of hypotension in patients with microbiologically confirmed acute melioidosis who receive antimicrobial therapy directed against B. pseudomallei
Measured: enrollment through day 90
Determine clinical cure rates among patients with of microbiologically confirmed acute melioidosis who are treated with ceftazidime
Percentage of each clinical outcome of microbiologically confirmed acute melioidosis by antimicrobial treatment regimen
Measured: enrollment through day 90
Determine clinical cure rates among patients with microbiologically confirmed acute melioidosis who are treated with meropenem
Percentage of each clinical outcome of microbiologically confirmed acute melioidosis by antimicrobial treatment regimen
Measured: enrollment through day 90
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
Percentage of each clinical outcome of "suspected melioidosis patients" to an appropriate antibiotic (ceftazidime or meropenem) in the subset of patients with no other microbiologically confirmed diagnosis (monomicrobial acute melioidosis)
Measured: enrollment through day 90
Antimicrobial durations of treatment of microbiologically confirmed acute melioidosis
Antimicrobial durations of treatment of microbiologically confirmed acute melioidosis (including parenteral therapy during the initial phase of treatment and oral therapy during the eradication phase)
Measured: enrollment through day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start1 Nov 2023
- Primary completion31 Oct 2024
- Study completion2 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelioidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- AN2 Therapeutics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mahidol Oxford Tropical Medicine Research Unit
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06089668
- Sponsor's protocol ID
- MEL-OB1
- Status last verified
- May 2025
- First submitted
- 5 Oct 2023
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study to Evaluate Clinical Characteristics, Current Practice and Outcomes of Adult Patients With Suspected or Confirmed Melioidosis
- ClinicalTrials.gov ID
- NCT06089668
- Acronym / sponsor ID
- MEL-OB1
- Conditions
- Melioidosis
- Keywords
- Melioidosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- AN2 Therapeutics, IncIndustry (pharma, biotech, devices)
- Collaborators
- Mahidol Oxford Tropical Medicine Research Unit
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 2 Feb 2025 (actual)
- First posted
- 18 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in Thailand and Laos with suspected or confirmed melioidosis
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational StudyNone, this is a non-interventional trial | Other | – |
Primary outcome
Data Collection of patients in Thailand with "suspected melioidosis"
Time frame: 2 years
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.
Data Collection of patients in Thailand with "microbiologically confirmed melioidosis ".
Time frame: 2 years
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.
Data Collection of patients in Laos with "suspected melioidosis"
Time frame: 2 years
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.
Data Collection of patients in Laos with "microbiologically confirmed melioidosis ".
Time frame: 2 years
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.
17 secondary outcomes
Use ± Immunofluorescence Microscopy (IFM) to Determine the percentage of "suspected melioidosis patients" with microbiologically confirmed disease
Time frame: 2 Years
Use ± Polymerase Chain Reaction (PCR) to Determine the percentage of "suspected melioidosis patients" with microbiologically confirmed disease
Time frame: 2 Years
Determine the rates of Burkholderia pseudomallei eradication in patients with microbiologically confirmed acute melioidosis
Time frame: 28 days after enrollment
Determine frequency of specific involvement of organ systems involvement in patients with microbiologically confirmed acute melioidosis
Time frame: 28 days after enrollment
Measure rate to resolution of bacteremia conversion to negative cultures
Time frame: 28 days after enrollment
Measure time to resolution of bacteremia conversion to negative cultures
Time frame: 28 days after enrollment
Frequency of Liver involvement in patients with microbiologically confirmed acute melioidosis (as diagnosed per standard of care)
Time frame: 28 days after enrollment
Frequency of Skin involvement in patients with microbiologically confirmed acute melioidosis (as diagnosed per standard of care)
Time frame: 28 days after enrollment
Frequency of Lung involvement in patients with microbiologically confirmed acute melioidosis (as diagnosed per standard of care)
Time frame: 28 days after enrollment
Frequency of Spleen involvement in patients with microbiologically confirmed acute melioidosis (as diagnosed per standard of care)
Time frame: 28 days after enrollment
Time to resolution of sepsis
Time frame: enrollment through day 90
Time to resolution of fever
Time frame: enrollment through day 90
Time to resolution of hypotension
Time frame: enrollment through day 90
Determine clinical cure rates among patients with of microbiologically confirmed acute melioidosis who are treated with ceftazidime
Time frame: enrollment through day 90
Determine clinical cure rates among patients with microbiologically confirmed acute melioidosis who are treated with meropenem
Time frame: enrollment through day 90
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
Time frame: enrollment through day 90
Antimicrobial durations of treatment of microbiologically confirmed acute melioidosis
Time frame: enrollment through day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melioidosis, run by AN2 Therapeutics, Inc at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Thailand, Laos. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Data Collection of patients in Thailand with "suspected melioidosis" (time frame: 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.