Efficacy of Artemether/Lumefantrine for the Treatment of Uncomplicated Malaria.

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Artemether-lumefantrine has been used in Tanzania as first-line treatment for uncomplicated malaria since 2007. Nonetheless, a report of increased proportion of patients with parasitaemia on day 1 following treatment with artemisinin based combination therapies has emerged from Kenya. Similarly, resistance against artemisinins has been confirmed in South-East Asia and it can spread to Africa. Therefore, the purpose of this study was to assess the efficacy of Artemether-lumefantrine for the treatment of uncomplicated malaria among children after five years of wide scale use of the drug in Tanzania.

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

Details

• Lead Sponsor: Richard Mwaiswelo
• Collaborator: Karolinska Institutet
• Treatments: Artemether; Artemether-lumefantrine combination; Artemether, Lumefantrine Drug Combination; Artemisinins; Lumefantrine

Criteria

Inclusion Criteria:

• Mono-infection with P. falciparum

• Parasitaemia level of 2000 - 200,000/μL

• Absence of danger signs or signs of severe malaria

• Axillary temperature ≥ 37.5°C or history of fever 24 hours prior to coming to the facility

• Absence of other concomitant infections like pneumonia which can cause fever

• No use of antimalarial drug two weeks prior to the study

• Consent to comply to the protocol.

Exclusion Criteria:

• Presence of general danger signs or signs of severe falciparum malaria

• Severe malnutrition

• Febrile condition due to diseases other than malaria, such as measles, acute lower respiratory infection or other known chronic diseases

• Regular medication which might interfere with antimalarial pharmacokinetics

• History of hypersensitivity reactions or contraindications to any medicine being used in the trial.