Acute Febrile IllnessNCT04299412
Diagnostic Accuracy of the DPP II Assay
An observational study of Acute Febrile Illness and Melioidosis, run by Foundation for Innovative New Diagnostics, Switzerland at 1 site in Australia.
Trial summary
Burkholderia pseudomallei is responsible for melioidosis, a disease that can present a range of signs and symptoms and can be treated by a specific drug regimen. Diagnosis of melioidosis is made by isolation of the bacteria from body fluids or tissues such as blood, skin or sputum. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Febrile Illness, Melioidosis, Diagnoses Disease
- What is being tested?
- DPP Fever Panel II assay
- Type of treatment
- Medical device
- How many people
- 104 participants
- Where
- 1 siteAustralia
- Study dates
- 28 Oct 2019to 30 Sep 2020
- 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: Sera samples were collected between December 2014 and June 2018 for the "Assessment of a New Rapid Diagnostic Test for Melioidosis" study that was conducted by the Menzies School of Health Research in Darwin, Australia. Patients recruited during that study presented to the Royal Darwin Hospital (RDH) with suspicion of melioidosis and consented to provide blood samples and to allow their use in diagnostic studies. Their samples are stored at -80°C in the Tropical and Emerging Infectious Diseases laboratory at the Menzies School of Health Research.
Who may be able to join
- Samples that can be included in the trial must have been collected exclusively during the "Assessment of a New Rapid Diagnostic Test for Melioidosis" study (HREC 04/09) conducted by the Menzies School of Health Research. They must be well-characterized with confirmation of presence or absence of B. pseudomallei by bacterial culture.
Who cannot join
- Samples with volume <120 µL
- Samples collected during projects other than the HREC 04/09 project
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Accuracy of the DPP Fever Panel II Asia and the DPP Micro Reader
Burkholderia pseudomallei is responsible for melioidosis, a disease that can present a range of signs and symptoms and can be treated by a specific drug regimen. Diagnosis of melioidosis is made by isolation of the bacteria from body fluids or tissues such as blood, skin or sputum. Although this is considered the gold standard, bacterial isolation has low diagnostic sensitivity, requires specific infrastructures (biosafety level 3 laboratories) and skilled staff that are not always available in LMICs. This may lead to inappropriate patient management and care.
Chembio, in partnership with FIND, has developed a multiplex lateral flow immunoassay (DPP® Fever Panel II Assay) that is able to detect antigens from common causes of febrile illnesses, included Burkholderia. FIND will conduct a laboratory study in Menzies Health School of Research to estimate the diagnostic accuracy of the DPP II Assay using retrospective samples that are positive for B. pseudomallei. Results will help in estimating the diagnostic accuracy of the assay for this pathogen.
- Conditions
- Acute Febrile Illness, Melioidosis, Diagnoses Disease
- Being tested
- DPP Fever Panel II assay
- Medical subject headings
- Melioidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DPP Fever Panel II assayDevice
Multiplex lateral flow immunoassay (DPP® Fever Panel II Assay) that is able to detect (i) antigens produced by Dengue, Zika, Chikungunya, Malaria and Burkholderia and (ii) IgM directed against Dengue, Zika, Chikungunya, Leptospira, Rickettsia typhi and Orientia tsutsugamushi. The assay comes with a reader that provides results interpretation to the operator in a few seconds
| Study group | Role | What they receive |
|---|---|---|
| Melioidosis cases | serum samples collected from patients with B. pseudomallei positive cultures Receives: Device: DPP Fever Panel II assay | |
| Non-melioidosis cases | serum samples collected from patients with B. pseudomallei negative cultures Receives: Device: DPP Fever Panel II assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Point estimates of sensitivity and specificity, with 95% confidence intervals, for the detection of B. pseudomallei by the DPP assay in comparison to a reference standard.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start28 Oct 2019
- Primary completion30 Jul 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Febrile IllnessStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation for Innovative New Diagnostics, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04299412
- Sponsor's protocol ID
- FE005
- Status last verified
- Nov 2023
- First submitted
- 5 Mar 2020
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of the DPP Fever Panel II Asia and the DPP Micro Reader
- ClinicalTrials.gov ID
- NCT04299412
- Acronym / sponsor ID
- FE005
- Conditions
- Acute Febrile Illness, Melioidosis, Diagnoses Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Foundation for Innovative New Diagnostics, SwitzerlandUniversity, hospital or other
- Study start
- 28 Oct 2019 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 6 Mar 2020 (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.
Burkholderia pseudomallei is responsible for melioidosis, a disease that can present a range of signs and symptoms and can be treated by a specific drug regimen. Diagnosis of melioidosis is made by isolation of the bacteria from body fluids or tissues such as blood, skin or sputum. Although this is considered the gold standard, bacterial isolation has low diagnostic sensitivity, requires specific infrastructures (biosafety level 3 laboratories) and skilled staff that are not always available in LMICs. This may lead to inappropriate patient management and care.
Chembio, in partnership with FIND, has developed a multiplex lateral flow immunoassay (DPP® Fever Panel II Assay) that is able to detect antigens from common causes of febrile illnesses, included Burkholderia. FIND will conduct a laboratory study in Menzies Health School of Research to estimate the diagnostic accuracy of the DPP II Assay using retrospective samples that are positive for B. pseudomallei. Results will help in estimating the diagnostic accuracy of the assay for this pathogen.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Melioidosis cases | – | Device: DPP Fever Panel II assayserum samples collected from patients with B. pseudomallei positive cultures |
| Non-melioidosis cases | – | Device: DPP Fever Panel II assayserum samples collected from patients with B. pseudomallei negative cultures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Sera samples were collected between December 2014 and June 2018 for the "Assessment of a New Rapid Diagnostic Test for Melioidosis" study that was conducted by the Menzies School of Health Research in Darwin, Australia. Patients recruited during that study presented to the Royal Darwin Hospital (RDH) with suspicion of melioidosis and consented to provide blood samples and to allow their use in diagnostic studies. Their samples are stored at -80°C in the Tropical and Emerging Infectious Diseases laboratory at the Menzies School of Health Research.
Key inclusion criteria (1 listed)
- Samples that can be included in the trial must have been collected exclusively during the "Assessment of a New Rapid Diagnostic Test for Melioidosis" study (HREC 04/09) conducted by the Menzies School of Health Research. They must be well-characterized with confirmation of presence or absence of B. pseudomallei by bacterial culture.
Key exclusion criteria (2 listed)
- Samples with volume <120 µL
- Samples collected during projects other than the HREC 04/09 project
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 |
|---|---|---|
| DPP Fever Panel II assayMultiplex lateral flow immunoassay (DPP® Fever Panel II Assay) that is able to detect (i) antigens produced by Dengue, Zika, Chikungunya, Malaria and Burkholderia and (ii) IgM directed against Dengue, Zika, Chikungunya, Leptospira, Rickettsia typhi and Orientia tsutsugamushi. The assay comes with a reader that provides results interpretation to the operator in a few seconds | Device | Melioidosis cases, Non-melioidosis cases |
Primary outcome
Point estimates of sensitivity and specificity, with 95% confidence intervals, for the detection of B. pseudomallei by the DPP assay in comparison to a reference standard.
Time frame: 2 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 30 Nov 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Acute Febrile Illness
RecruitingObservational study
Febrile Infants Swedish Study
Febrile Illness Acute, Meningitis, Bacterial
RecruitingPhase 4
Immunogenicity and Safety PCV-20 of the Vaccine Administered During an Acute Febrile Illness in Adults
Acute Febrile Illness, Pneumococcal Infections
RecruitingObservational study
Clinical Aspects, Management and Surveillance of Febrile Illnesses in DRC
Febrile Illness Acute, Biomarkers
RecruitingObservational study
Causes and Outcomes of Febrile Illness in Health Facilities in Rural South and Southeast Asia
Acute Febrile Illness
RecruitingObservational study
The Fever Clinic Acute Respiratory Cohort
Acute Respiratory Infections, Febrile Illnesses
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.
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 Acute Febrile Illness and Melioidosis, run by Foundation for Innovative New Diagnostics, Switzerland at 1 site in Australia.
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 1 inclusion and 2 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 30 Nov 2023. 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 Australia. 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?
Point estimates of sensitivity and specificity, with 95% confidence intervals, for the detection of B. pseudomallei by the DPP assay in comparison to a reference standard. (time frame: 2 months). 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 30 Nov 2023.