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Validation of Promising Biomarker Assays to Assess Their Diagnostic Performance Characteristics

NCT03047642 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2000

Last updated 2021-02-16

No results posted yet for this study

Summary

This project aims to evaluate the performance characteristics of rapid tests to differentiate bacterial from non-bacterial infection in febrile adults and children presenting at OPDs (outpatient departments) i.e.("fever triage assays") in three LMICs. The evaluation will include a different commercial biomarker combinations as well as individual biomarkers to assess their individual or combined value in the target population. Markers will be evaluated onsite in ELISA or RDT format, as appropriate. Further, this study aims to contribute to a centralized biobank of well-characterized specimens for use by IVD companies and academic institutions for the development and evaluation of emerging assays.

Conditions

  • Acute Febrile Illnesses

Interventions

DIAGNOSTIC_TEST

Biomarker assay

There is no intervention on the patients but biomarker assays are being evaluated for their performance to distinguish bacterial infection from non-bacterial infections in febrile patients

Sponsors & Collaborators

  • Malawi Epidemiology and Intervention Research Unit

    collaborator OTHER

  • Instituto Nacional de Infectologia Evandro Chagas

    collaborator UNKNOWN

  • Centre de Recherche Médicale de Lambaréné

    collaborator OTHER

  • Foundation for Innovative New Diagnostics, Switzerland

    lead OTHER

Eligibility

Min Age
2 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-27
Primary Completion
2018-10-27
Completion
2019-11-27

Countries

  • Brazil
  • Gabon
  • Malawi

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03047642 on ClinicalTrials.gov