Evaluation of the DPP II Assay in Laos

NCT ID: NCT04299607

Last Updated: 2021-03-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-11-12
• Study Completion Date: 2020-11-30

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.

Conditions

Acute Febrile Illness

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

DPP Fever Panel II assay and DPP Micro Readers

Intervention Type: DIAGNOSTIC_TEST

Detection of common causes of acute febrile illnesses in Asia

Interventions

DPP Fever Panel II assay and DPP Micro Readers

Detection of common causes of acute febrile illnesses in Asia

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Foundation for Innovative New Diagnostics, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

LOMWRU, Mahosot Hospital

Vientiane, , Laos

Countries

Laos

Other Identifiers

FE004

Identifier Type: -

Identifier Source: org_study_id