Clinical trial NCT04299607: Evaluation of the DPP II Assay in Laos
Official title: Performance Assessment of the DPP Fever Panel II Assay for Detection of Infectious Causes of Acute Febrile Illness in Laos
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Febrile Illness
Lead sponsor: Foundation for Innovative New Diagnostics, Switzerland
Sponsor class: OTHER
First posted: 2020-03-09
Enrollment: 300
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percentage of samples with concordant results for marker detection in paired whole blood and serum samples for each reader
timeFrame: 5 months
measure: Optimal reader cut-offs for serum samples and for blood samples to obtain the overall highest diagnostic accuracy per sample type
timeFrame: 5 months
measure: 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
timeFrame: 5 months
measure: 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
timeFrame: 5 months
Secondary outcomes:
measure: Estimates of sensitivity and specificity of the DPP assay for detection of fever causative agents using venous blood samples, in comparison to reference tests
timeFrame: 5 months
measure: Estimates of sensitivity and specificity of the DPP assay for detection of fever causative agents using serum samples, in comparison to reference tests.
timeFrame: 5 months
measure: Estimates of operational characteristics, including invalid and indeterminate rates
timeFrame: 5 months
measure: Estimates of ease-of-use will be captured through user-appraisal questionnaire.
timeFrame: 5 months
Other outcomes:
Locations:
city: Vientiane
country: Lao People's Democratic Republic
facility: LOMWRU, Mahosot Hospital
Study officials:
References: