In Vivo Efficacy of Artemether-Lumefantrine and Artesunate-Amodiaquine for Uncomplicated P. Falciparum Malaria

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This study was designed to determine the efficacy of both artemether-lumefantrine and artesunate-amodiaquine (but not to compare the efficacies of the two drugs) for the treatment of uncomplicated Plasmodium falciparum malaria at Machinga, Nkhotakota, and Karonga District Hospitals- Malawi.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centers for Disease Control and Prevention
• Collaborator: University of Malawi College of Medicine
• Treatments: Amodiaquine; Artemether; Artemether-lumefantrine combination; Artemether, Lumefantrine Drug Combination; Artemisinins; Artesunate; Lumefantrine

Criteria

Inclusion Criteria:

• age between 6 to 59 months

• mono-infection with P. falciparum detected by microscopy

• parasitaemia of 1,000-200,000/µl asexual forms

• presence of axillary temperature ≥ 37.5 °C or history of fever during the past 24 h

• ability to swallow oral medication

• ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule

• informed consent from the parent or guardian of the child

Exclusion Criteria:

• presence of general danger signs in children aged 6-59 months or signs of severe falciparum malaria according to the definitions of World Health Organization

• mixed or mono-infection with another Plasmodium species detected by microscopy

• presence of severe malnutrition (defined as a child whose growth standard is below -3 z-score)

• presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS)

• regular medication that may interfere with antimalarial pharmacokinetics

• history of hypersensitivity reactions or contraindications to any of the medicines being tested or used as alternative treatments