MelioidosisNCT03528265
Adapting LFI for Melioidosis
An observational study of Melioidosis, run by Duke University at 1 site in Malaysia.
Trial summary
Towards the goal of reducing melioidosis, this study will help clinicians in Sarawak to diagnose and understand the causes and risk factors for melioidosis. The data will help the clinicians to provide faster test results and better clinical care. Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- Melioidosis
- What is being tested?
- Lateral flow immunoassay
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteMalaysia
- Study dates
- 21 Jun 2018to 8 Jan 2019
- 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 6 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients evaluated at Kapit Hospital experiencing melioidosis-like symptoms.
Who may be able to join
- Admitted to Kapit Hospital
- Fever more than 3 days and one or more of the following:
- Enlarged cervical, inguinal or axillary lymph nodes (greater than 3 cm in diameter), painless adenopathy or lymphadenitis or lymph node abscesses
- One or both sides glands involvement such as tender swelling over medial aspect of the lower eyelid of the lacrimal glands; submandibular glands, parotic glands
- Bedside scan with splenic or liver hypoechoic lesion (less than 2cm in diameter)
- Pneumonia not responding to 48 hours of first line antibiotics
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- One or more joint pain with swelling
- Purplish vesicle or bullae mainly over the lower limbs, may resulting in ulcer after rupture
- Deep seated abscess or brain abscess or genitourinary abscess or osteomyelitis
- Severe sepsis patient with or without shock and/or with multiorgan involvement
Who cannot join
- Have a clear alternative diagnosis other than melioidosis by a trained health care professional at the Kapit Hospital
- Have already been treated for melioidosis (e.g. received antibiotics before the start of the study)
- Are younger than 6 months of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adapting a Rapid Lateral Flow Burkholderia Pseudomallei Immunoassay in Sarawak, Malaysia
Towards the goal of reducing melioidosis, this study will help clinicians in Sarawak to diagnose and understand the causes and risk factors for melioidosis. The data will help the clinicians to provide faster test results and better clinical care. The investigator's laboratory efforts will supplement available diagnostics by adding a new, easier-to-use test involving lateral flow immunoassay to rapidly detect Burkholderia pseudomallei, a bacterium causing melioidosis. The study aims to study up to 400 patients with melioidosis-like symptoms who are admitted to Kapit Hospital, Sarawak, Malaysia. No participants will be enrolled from other sites. The study will also examine the demographic, behavioral and occupational risk factors associated with hospital admissions to understand any existing associations between these variables and melioidosis prevalence.
- Conditions
- Melioidosis
- Being tested
- Lateral flow immunoassay
- Keywords
- lateral flow immunoassay, validation
- Medical subject headings
- Melioidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lateral flow immunoassayDevice
Biospecimens of patients with melioidosis-like symptoms will be tested with lateral flow immunoassay to detect Burkholderia pseudomallei, bacterium causing melioidosis
| Study group | Role | What they receive |
|---|---|---|
| Patients with melioidosis-like symptoms admitted to Kapit Hosp | Not described Receives: Device: Lateral flow immunoassay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of true positive
Proportion of true positive of Bukholderia pseudomallei using rapid diagnostic tests compared to the results of qPCR, bacterial culture and Gram stain
Measured: up to 5 weeks
Proportion of true negative
Proportion of true negative of Bukholderia pseudomallei using rapid diagnostic tests compared to the results of qPCR, bacterial culture and Gram stain
Measured: up to 5 weeks
Secondary outcomes (1)
Statistical association between risk factors and test results
conduct a survey to determine a statistical association between clinical risk factors and the test results combined
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study start21 Jun 2018
- Primary completion8 Jan 2019
- Study completion8 Jan 2019
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.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gregory C Gray, MD, MPH, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03528265
- Sponsor's protocol ID
- Pro00091842
- Status last verified
- Jul 2018
- First submitted
- 7 May 2018
- Last updated
- 1 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting a Rapid Lateral Flow Burkholderia Pseudomallei Immunoassay in Sarawak, Malaysia
- ClinicalTrials.gov ID
- NCT03528265
- Acronym / sponsor ID
- Pro00091842
- Conditions
- Melioidosis
- Keywords
- lateral flow immunoassay, validation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 21 Jun 2018 (actual)
- Primary completion
- 8 Jan 2019 (actual)
- Study completion
- 8 Jan 2019 (actual)
- First posted
- 17 May 2018 (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.
Towards the goal of reducing melioidosis, this study will help clinicians in Sarawak to diagnose and understand the causes and risk factors for melioidosis. The data will help the clinicians to provide faster test results and better clinical care. The investigator's laboratory efforts will supplement available diagnostics by adding a new, easier-to-use test involving lateral flow immunoassay to rapidly detect Burkholderia pseudomallei, a bacterium causing melioidosis. The study aims to study up to 400 patients with melioidosis-like symptoms who are admitted to Kapit Hospital, Sarawak, Malaysia. No participants will be enrolled from other sites. The study will also examine the demographic, behavioral and occupational risk factors associated with hospital admissions to understand any existing associations between these variables and melioidosis prevalence.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with melioidosis-like symptoms admitted to Kapit Hosp | – | Device: Lateral flow immunoassay |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients evaluated at Kapit Hospital experiencing melioidosis-like symptoms.
Key inclusion criteria (10 listed)
- Admitted to Kapit Hospital
- Fever more than 3 days and one or more of the following:
Key exclusion criteria (3 listed)
- Have a clear alternative diagnosis other than melioidosis by a trained health care professional at the Kapit Hospital
- Have already been treated for melioidosis (e.g. received antibiotics before the start of the study)
- Are younger than 6 months of age
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 |
|---|---|---|
| Lateral flow immunoassayBiospecimens of patients with melioidosis-like symptoms will be tested with lateral flow immunoassay to detect Burkholderia pseudomallei, bacterium causing melioidosis | Device | Patients with melioidosis-like symptoms admitted to Kapit Hosp |
Primary outcome
Proportion of true positive
Time frame: up to 5 weeks
Proportion of true positive of Bukholderia pseudomallei using rapid diagnostic tests compared to the results of qPCR, bacterial culture and Gram stain
Proportion of true negative
Time frame: up to 5 weeks
Proportion of true negative of Bukholderia pseudomallei using rapid diagnostic tests compared to the results of qPCR, bacterial culture and Gram stain
1 secondary outcome
Statistical association between risk factors and test results
Time frame: up to 3 months
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 1 Aug 2019.
- Individual participant dataSharing planned: No
Related trials for Melioidosis
RecruitingObservational study
Environment, Pathogens, and Host Interactions in Melioidosis
Melioidosis
RecruitingObservational study
Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective
Dengue, Chikungunya
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.
Gregory C Gray, MD, MPH principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melioidosis, run by Duke University at 1 site in Malaysia.
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 10 inclusion and 3 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 1 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. 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?
Proportion of true positive (time frame: up to 5 weeks). The study lists 2 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 1 Aug 2019.