Acute Febrile IllnessNCT04299607
Evaluation of the DPP II Assay in Laos
An observational study of Acute Febrile Illness, run by Foundation for Innovative New Diagnostics, Switzerland at 1 site in Laos.
Trial summary
Fever is the most frequent symptom in patients seeking care globally. Several causative agents of febrile illness have been described with a high prevalence in South East Asia. They include malaria, dengue, Rickettsia, Leptospira and Burkholderia species. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Acute Febrile Illness
- What is being tested?
- DPP Fever Panel II assay and DPP Micro Readers
- How many people
- 300 participants
- Where
- 1 siteLaos
- Study dates
- 12 Nov 2019to 30 Nov 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 12 years and older
- All sexes
- Child, Adult, Older adult
Study population: The population consists of samples collected from individuals who consent to participate to the "Prospective study of the causes of fever ("UI-2" Study) amongst patients admitted to Mahosot Hospital, Vientiane, Lao PDR" (OxTREC reference: 006-07). Individuals provide blood samples for routine laboratory tests and blood leftovers will be used during this trial.
Who may be able to join
- Participants > 12 years old enrolled in the "Prospective study of the causes of fever amongst patients admitted to Mahosot Hospital, Vientiane, Lao PDR" (UI-2 study).
- Fever (≥ 37.5 °C)
- Illness duration < 14 days
- Willingness to provide blood samples by venepuncture
Who cannot join
- Absence of consent (and assent for children) to participate to the "Prospective study of the causes of fever amongst patients admitted to Mahosot Hospital, Vientiane, Lao PDR" (UI-2 study).
- Non-infectious known or suspected cause of fever
- No left over blood sample or insufficient volume of left over sample
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Performance Assessment of the DPP Fever Panel II Assay for Detection of Infectious Causes of Acute Febrile Illness in Laos
Fever is the most frequent symptom in patients seeking care globally. Several causative agents of febrile illness have been described with a high prevalence in South East Asia. They include malaria, dengue, Rickettsia, Leptospira and Burkholderia species. Since their introduction in the market, rapid diagnostic tests for malaria have driven patient management and care. Malaria negative cases are commonly treated with antibiotics without confirmation of bacteraemia. This can be explained by conventional laboratory diagnostic tests such as blood culture that usually require a skilled staff and appropriate facilities.
Several Rapid Diagnostic tests (RDTs) are currently in the market but only limited data on their performance are available, rendering them unsuitable to replace laboratory conventional tests. In addition, RDTs have been developed for single disease diagnosis and remain costly for Low and Middle Income Countries (LMIC).
Read more
Chembio, in collaboration with FIND (Foundation for Innovative New Diagnostics) and MORU (Mahidol Oxford Tropical Medicine Research Unit), has developed a multiplex lateral flow immunoassay (DPP® Fever Panel II Assay) that is able to detect serum immunoglobulin M (IgM) and specific microbial antigen of the most common agents of Acute Febrile Illness (AFI) in Asia. The assay comes with a reader that provides results interpretation to the operator.
So far, DPP II assay performance has been estimated using a limited number of retrospective serum samples. More data are required to assess the performance of the assay using prospective serum samples. In addition, only limited data are available regarding the performance of the assay using blood samples. FIND will conduct a clinical trial to estimate the clinical performance of the assay in comparison to reference tests, using blood and serum samples and in intended settings of use.
- Conditions
- Acute Febrile Illness
- Being tested
- DPP Fever Panel II assay and DPP Micro Readers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DPP Fever Panel II assay and DPP Micro ReadersDiagnostic test
Detection of common causes of acute febrile illnesses in Asia
| Study group | Role | What they receive |
|---|---|---|
| AFI patients | Blood will be collected from patients presenting with an undifferentiated fever.
Samples will be tested with:
* the Malaria Ag Pf/Pan test SD Bioline
* the SD Bioline Dengue Duo IgM/IgG/NS1
* the DPP Zika Chikungunya Dengue test from Chembio
* the DPP Fever Panel II assay
* the Leptospira IgM ELISA test from Serion
* an in-house ELISA tests for scrub and murine typhus IgM
* blood culture for detection of Burkholderia pseudomallei Receives: Diagnostic Test: DPP Fever Panel II assay and DPP Micro Readers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of samples with concordant results for marker detection in paired whole blood and serum samples for each reader
The percentage of samples with concordant results using two types of assay readers will be calculated for each marker and each specimen type (blood and serum)
Measured: 5 months
Optimal reader cut-offs for serum samples and for blood samples to obtain the overall highest diagnostic accuracy per sample type
The reader cut-offs (numerical values) that give the highest specificity and specificity will calculated for each marker and reader
Measured: 5 months
Percentage of more targeted treatments that would have been prescribed if the DPP II assay test was used in routine in comparison to actual prescribed treatments and to treatment that would have been prescribed based on comparator tests
In comparison to reference tests and routine tests, the impact of the DPP Fever Panel II assay on antibiotic prescriptions will be modeled
Measured: 5 months
Cost impact of more targeted treatments that would have been prescribed if the DPP II assay test was used in routine in comparison to actual prescribed treatments and to treatment that would have been prescribed based on comparator tests
In comparison to reference tests and routine tests, the impact of the DPP Fever Panel II assay on health costs will be modeled.
Measured: 5 months
Secondary outcomes (4)
Estimates of sensitivity and specificity of the DPP assay for detection of fever causative agents using venous blood samples, in comparison to reference tests
Measured: 5 months
Estimates of sensitivity and specificity of the DPP assay for detection of fever causative agents using serum samples, in comparison to reference tests.
Measured: 5 months
Estimates of operational characteristics, including invalid and indeterminate rates
The % of invalid results and indeterminate rates will be calculated.
Measured: 5 months
Estimates of ease-of-use will be captured through user-appraisal questionnaire.
Answers to each question will be graded either positive, neutral or negative. The % and absolute numbers of positive, neutral and negative answers will be reported in tables and charts.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study start12 Nov 2019
- Primary completion30 Nov 2020
- Study completion30 Nov 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 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
- NCT04299607
- Sponsor's protocol ID
- FE004
- Status last verified
- Mar 2021
- First submitted
- 26 Nov 2019
- Last updated
- 10 Mar 2021
- 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 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Assessment of the DPP Fever Panel II Assay for Detection of Infectious Causes of Acute Febrile Illness in Laos
- ClinicalTrials.gov ID
- NCT04299607
- Acronym / sponsor ID
- FE004
- Conditions
- Acute Febrile Illness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Foundation for Innovative New Diagnostics, SwitzerlandUniversity, hospital or other
- Study start
- 12 Nov 2019 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 9 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.
Fever is the most frequent symptom in patients seeking care globally. Several causative agents of febrile illness have been described with a high prevalence in South East Asia. They include malaria, dengue, Rickettsia, Leptospira and Burkholderia species. Since their introduction in the market, rapid diagnostic tests for malaria have driven patient management and care. Malaria negative cases are commonly treated with antibiotics without confirmation of bacteraemia. This can be explained by conventional laboratory diagnostic tests such as blood culture that usually require a skilled staff and appropriate facilities.
Several Rapid Diagnostic tests (RDTs) are currently in the market but only limited data on their performance are available, rendering them unsuitable to replace laboratory conventional tests. In addition, RDTs have been developed for single disease diagnosis and remain costly for Low and Middle Income Countries (LMIC).
Chembio, in collaboration with FIND (Foundation for Innovative New Diagnostics) and MORU (Mahidol Oxford Tropical Medicine Research Unit), has developed a multiplex lateral flow immunoassay (DPP® Fever Panel II Assay) that is able to detect serum immunoglobulin M (IgM) and specific microbial antigen of the most common agents of Acute Febrile Illness (AFI) in Asia. The assay comes with a reader that provides results interpretation to the operator.
So far, DPP II assay performance has been estimated using a limited number of retrospective serum samples. More data are required to assess the performance of the assay using prospective serum samples. In addition, only limited data are available regarding the performance of the assay using blood samples. FIND will conduct a clinical trial to estimate the clinical performance of the assay in comparison to reference tests, using blood and serum samples and in intended settings of use.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AFI patients | – | Diagnostic Test: DPP Fever Panel II assay and DPP Micro ReadersBlood will be collected from patients presenting with an undifferentiated fever. Samples will be tested with: * the Malaria Ag Pf/Pan test SD Bioline * the SD Bioline Dengue Duo IgM/IgG/NS1 * the DPP Zika Chikungunya Dengue test from Chembio * the DPP Fever Panel II assay * the Leptospira IgM ELISA test from Serion * an in-house ELISA tests for scrub and murine typhus IgM * blood culture for detection of Burkholderia pseudomallei |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The population consists of samples collected from individuals who consent to participate to the "Prospective study of the causes of fever ("UI-2" Study) amongst patients admitted to Mahosot Hospital, Vientiane, Lao PDR" (OxTREC reference: 006-07). Individuals provide blood samples for routine laboratory tests and blood leftovers will be used during this trial.
Key inclusion criteria (4 listed)
- Participants > 12 years old enrolled in the "Prospective study of the causes of fever amongst patients admitted to Mahosot Hospital, Vientiane, Lao PDR" (UI-2 study).
- Fever (≥ 37.5 °C)
- Illness duration < 14 days
- Willingness to provide blood samples by venepuncture
Key exclusion criteria (3 listed)
- Absence of consent (and assent for children) to participate to the "Prospective study of the causes of fever amongst patients admitted to Mahosot Hospital, Vientiane, Lao PDR" (UI-2 study).
- Non-infectious known or suspected cause of fever
- No left over blood sample or insufficient volume of left over sample
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 assay and DPP Micro ReadersDetection of common causes of acute febrile illnesses in Asia | Diagnostic test | AFI patients |
Primary outcome
Percentage of samples with concordant results for marker detection in paired whole blood and serum samples for each reader
Time frame: 5 months
The percentage of samples with concordant results using two types of assay readers will be calculated for each marker and each specimen type (blood and serum)
Optimal reader cut-offs for serum samples and for blood samples to obtain the overall highest diagnostic accuracy per sample type
Time frame: 5 months
The reader cut-offs (numerical values) that give the highest specificity and specificity will calculated for each marker and reader
Percentage of more targeted treatments that would have been prescribed if the DPP II assay test was used in routine in comparison to actual prescribed treatments and to treatment that would have been prescribed based on comparator tests
Time frame: 5 months
In comparison to reference tests and routine tests, the impact of the DPP Fever Panel II assay on antibiotic prescriptions will be modeled
Cost impact of more targeted treatments that would have been prescribed if the DPP II assay test was used in routine in comparison to actual prescribed treatments and to treatment that would have been prescribed based on comparator tests
Time frame: 5 months
In comparison to reference tests and routine tests, the impact of the DPP Fever Panel II assay on health costs will be modeled.
4 secondary outcomes
Estimates of sensitivity and specificity of the DPP assay for detection of fever causative agents using venous blood samples, in comparison to reference tests
Time frame: 5 months
Estimates of sensitivity and specificity of the DPP assay for detection of fever causative agents using serum samples, in comparison to reference tests.
Time frame: 5 months
Estimates of operational characteristics, including invalid and indeterminate rates
Time frame: 5 months
Estimates of ease-of-use will be captured through user-appraisal questionnaire.
Time frame: 5 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 10 Mar 2021.
- Individual participant dataSharing planned: Undecided
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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.
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, run by Foundation for Innovative New Diagnostics, Switzerland at 1 site in Laos.
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 4 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 10 Mar 2021. 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 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?
Percentage of samples with concordant results for marker detection in paired whole blood and serum samples for each reader (time frame: 5 months). 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 10 Mar 2021.