Artemether-Lumefantrine (AL) Unit Dose Pre-packs Versus Blister Packs

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if adherence and effectiveness of AL in the treatment of uncomplicated malaria in children aged under five years using blister packs with pictorial leaflets can be at levels comparable to those with unit dosed age specific pre-packs.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Malaria Consortium, Uganda
• Collaborators: Makerere University; Ministry of Health, Uganda
• Treatments: Artemether; Artemether-lumefantrine combination; Artemether, Lumefantrine Drug Combination; Lumefantrine

Criteria

Inclusion Criteria:

• Reported history of fever within last 48 hours and or an axillary temperature greater than or equal to 37.50C.

• Weight between 5 kg and 25 kg

• Positive malaria smear results for P. falciparum

• No history of intake of AL in the preceding two weeks

• Able to tolerate oral therapy

• Caregiver has given written informed consent to participate in the study

• If they reside within the designated catchment area of the health facility

Exclusion Criteria:

• Features of life threatening illness including severe malaria