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Optimizing Sysmex Technology as an Innovative Tool to Differentiate Between Malaria (PALUdism) and BACterial Infections in a Malaria Endemic Region

NCT02669823 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 930

Last updated 2017-07-21

No results posted yet for this study

Summary

Severe malaria and bacterial Blood Stream Infections (bBSI) are impossible to differentiate clinically. This poses a particular threat in low resource areas, where bBSI is often not diagnosed due to the unavailability of rapid diagnostic means. Even if used appropriately, the sensitivity of blood culture to diagnose bBSI is estimated to be around 50%. To counter the high mortality rate associated with bBSI, antibiotics are often prescribed without microbiological confirmation. Sysmex Company has developed technology that enables the rapid diagnosis of malaria using a venous blood sample. In addition algorithms based on hematological parameters can be used to monitor disease severity and progression, as well as guide further diagnostic testing based on differences seen in these parameters between various types of disease. The algorithms have been developed and tested in adult populations from different industrialized countries and in one Asian population. However no data are available neither from pediatric patients, nor from the sub-Saharan setting where the epidemiology of infectious diseases is very different from the tested settings. The objective of the study is to: 1) Assess the sensitivity and specificity of the Sysmex hematology analyzer based on the new technology to diagnose malaria in subjects older than 3 months, who present with an acute severe febrile illness in a malaria endemic area in sub-Saharan Africa 2) Test and optimize the value of Sysmex analyzers in disease diagnosis and monitoring in children older than 5 years and adults, who present with an acute severe febrile illness in a malaria endemic region in sub-Saharan Africa, to differentiate between severe malaria and bBSI, or a combination of these infections. 3) Explore the value of Sysmex analyzers in disease diagnosis and monitoring in children between 3 months and 5 years of age, who present with an acute severe febrile illness in a malaria endemic region in sub-Saharan Africa.

Conditions

  • Tropical Infectious Diseases

Interventions

OTHER

None, treatment as actual best practice

Sponsors & Collaborators

  • Clinical Research Unit of Nanaro (CRUN), Burkina Faso

    collaborator UNKNOWN

  • Instituut voor Tropische Geneeskunde (ITG), Belgium

    collaborator UNKNOWN

  • Radboud University Medical Center

    collaborator OTHER

  • Sysmex Europe GmbH

    lead INDUSTRY

Principal Investigators

  • Andre van der Ven · Radboud University Medical Center

  • Halidou Tinto · CRUN

  • Jan Jacobs · ITG

Eligibility

Min Age
3 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-01
Primary Completion
2017-06-30
Completion
2017-06-30

Countries

  • Burkina Faso

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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 NCT02669823 on ClinicalTrials.gov