Treatment of uncomplicated childhood malaria by artemether-lumefantrine (Coartem®) efficacy, effectiveness, safety and genotyping in Tanzania

Conditions

Malaria in under five children Infections and Infestations Malaria

Richard Mwaiswelo, Billy Ngasala, Irina Jovel, Weiping Xu, Erik Larsson et al. (10 authors)

American Journal of Tropical Medicine and Hygiene2019-03-1218 citations

Efficacy and effectiveness of artemether-lumefantrine after initial and repeated treatment in children <5 years of age with acute uncomplicated Plasmodium falciparum malaria in rural Tanzania: a randomized trial.

Ngasala BE, Malmberg M, Carlsson AM, Ferreira PE, Petzold MG, Blessborn D, Bergqvist Y, Gil JP, Premji Z, Björkman A, Mårtensson A.

2011-04-0152 citations

10.1093/cid/cir066

Interventions

In this clinical trial there is no intervention apart from early diagnosis and prompt treatment. Patients will be treated with Artemether-lumefantrine (Coartem®), given either under supervision or by

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Males or females less than five years of age with body weight greater than 5 kg 2. Suffering from acute uncomplicated P. falciparum malaria confirmed by microscopy using Giemsa-stained thick film with an asexual parasite density of 2,000 to 200,000 parasites/µl 3. Presenting with fever (axillary temperature equal to 37.5°C) or having a history of fever in the preceding 24 hours 4. Able to ingest tablets orally (either suspended in water or un-crushed with food)

Exclusion criteria

Exclusion criteria: 1. Present with any of the danger signs of severe malaria 2. Signs/symptoms indicating severe/complicated malaria according to World Health Organization (WHO) criteria (WHO definition) 3. Serious gastrointestinal disease, severe malnutrition (Weight-for-Height [W/H] less than 70%) or severe anaemia (haemoglobin less than 5 g/dl) 4. Known hypersensitivity to artemether-lumefantrine 5. Have been treated with any other drugs within eight weeks prior to screening or intend to use other drugs or biologics during the study

Design outcomes

Primary

Measure	Time frame
Polymerase Chain Reaction (PCR)-adjusted parasitological treatment response (cure, treatment failure) on days 14, 28, 42 and 56 after initial treatment, and on days 14, 28 and 42 after retreatment in supervised and unsupervised patients.	—

Secondary

Measure	Time frame
1. Occurrence of adverse events during 56 and 42 days after initial and retreatment 2. Recrudescence after initial and retreatment 3. Reinfection after initial treatment	—

Countries

Tanzania

Outcome results

None listed