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Monitoring of Molecular Markers of Artemisinin Resistance Through Repeated Cross-sectional Assessments in DR Congo, Nigeria and Uganda

NCT04037332 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 916

Last updated 2021-01-29

No results posted yet for this study

Summary

Currently, 16 African countries include the use of pre-referral rectal artesunate (RAS) in their treatment policies. However, guidelines for RAS use vary widely across countries and inappropriate use of RAS as a monotherapy and consequential development of resistances against artemisinin based treatments is of particular concern.

In the frame of the Unitaid-funded "Community Access to Rectal Artesunate for Malaria" (CARAMAL) Project, quality-assured RAS will be rolled in selected areas of the Democratic Republic of the Congo (DRC), Nigeria and Uganda. Approximately 3,000 treatments of RAS will be dispensed by trained community health workers to children \<5 years of age in each project country per year.

Linked to the tracking of (severe) malaria patients in the frame of the CARAMAL project, this study will assess the frequency of artemisinin resistance markers in the study settings and tentatively assess whether the introduction of RAS could increase the selection of resistant P. falciparum strains. The study will be conducted in close collaboration with the Global Malaria Programme of the WHO. Finger-prick blood samples will be collected from children \< 5 years of age with signs of severe febrile illness and a positive mRDT presenting to community-based providers and referral facilities before and after the pilot roll-out of pre-referral RAS at community level.

Conditions

  • Severe Malaria

Interventions

OTHER

Blood sample (combined with malaria RDT) followed by gentoyping analysis

Finger-prick blood samples collected from children with signs of severe febrile illness and a positive mRDT presenting to community-based providers and referral facilities ; analysis for mutations in portions of a P. falciparum gene encoding kelch (K13)-propeller domain

Sponsors & Collaborators

  • Clinton Health Access Initiative, Nigeria

    collaborator OTHER

  • Akena Associates Ltd.

    collaborator UNKNOWN

  • Kinshasa School of Public Health

    collaborator OTHER

  • Makerere University

    collaborator OTHER

  • Swiss Tropical & Public Health Institute

    lead OTHER

Principal Investigators

  • Christian Burri · Swiss TPH, Department of Medicine

  • Christian Lengeler, PhD · Swiss TPH, Department of Epidemiology and Public Health

Eligibility

Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-27
Primary Completion
2020-07-31
Completion
2020-07-31

Countries

  • Democratic Republic of the Congo
  • Nigeria
  • Uganda

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 NCT04037332 on ClinicalTrials.gov