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

ICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)0 sites360 target enrollmentMay 3, 2007

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Malaria in under five children
Sponsor: ICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)
Enrollment: 360
Status: Completed
Last Updated: 11 years ago

No summary available.

Registry

who.int

Start Date

May 3, 2007

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional

Sex

All

Sponsor

ICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)

•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)

•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