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Artemether-lumefantrine Resistance Monitoring in Children With Uncomplicated Plasmodium Falciparum Malaria in Mali

NCT02645604 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 154

Last updated 2019-12-17

No results posted yet for this study

Summary

Background: Malaria is a disease caused by a parasite. People get malaria if they are bitten by an parasite-infected mosquito. A drug called artemether-lumefantrine (AL) can treat malaria. Although iAL has helped make the malaria problem less severe in the African country of Mali, researchers want to find out if malaria parasites are becoming resistant to this drug.

Objective: To test for AL-resistant parasites in children with malaria in Mali.

Eligibility:

AL resistance monitoring study: children aged 2 17 years who live in Kenieroba, Mali, and have malaria.

Blood collection substudy: healthy volunteers aged 18 65 years.

Design:

Volunteers for the substudy will have blood taken up to 6 times a year.

Study participants will be screened with 1 finger-prick blood sample. Girls may have a pregnancy test.

Baseline visit: Participants will have a physical exam. Their vital signs and temperature will be measured. They will answer questions about their symptoms. They will give a blood sample.

Participants will get 6 doses of AL over 3 days. They will take it in tablet form with milk.

Some participants will also stay at the clinic for 2 days. They will have a catheter placed in a vein. They will have blood taken frequently.

Participants will have follow-up visits for about 1 month. They may have:

Physical exam performed

Vital signs and temperature measured

Symptom questionnaire administered

Finger-prick blood sample and/or a regular blood sample taken

Pregnancy test given

Antimalarial medications other than AL provided.

Conditions

  • Accute Falciparum Malaria

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Rick M Fairhurst, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility

Min Age
2 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-01-01
Primary Completion
2018-12-14
Completion
2018-12-14

Countries

  • Mali

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 NCT02645604 on ClinicalTrials.gov