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Accute Falciparum Malaria clinical trials

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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NCT ID: NCT02645604 Completed - Clinical trials for Accute Falciparum Malaria

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

Start date: January 1, 2016
Phase:
Study type: Observational

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.