Clinical Trial: Artemether-Lumefantrine (AL) Unit Dose Pre-packs Versus Blister Packs
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Effectiveness and Treatment Adherence to Artemether/Lumefantrine Pre-packs Versus Blister Packs in the Treatment of Uncomplicated Malaria in Uganda
Brief 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.
Detailed Summary: Prompt and adequate treatment of clinical malaria episodes remains one of the key elements of malaria control and this partly depends on patients' compliance to treatment. Uganda adopted Artemether-Lumefantrine (AL) as first line treatment for uncomplicated malaria. This is available at the health facilities in form of 6 dose pre-packs with different doze strengths in different packages. However, concerns about the costs and stock-outs of these packages have been raised and alternative equally efficacious alternatives need to be determined in order to reduce these problems. This study will assess if AL blister-packs can act as alternatives to the unit dose age specific pre-packs in the public sector
Sponsor: Malaria Consortium, Uganda
Current Primary Outcome: Adherence to Blister-packs versus unit dose pre-packs as measured by pill count and self report. [ Time Frame: Day 3 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Parasitological cure rates [ Time Frame: Day 28 ]
- Clinical cure rates [ Time Frame: Days 3 ]
Original Secondary Outcome: Same as current
Information By: Malaria Consortium, Uganda
Dates:
Date Received: February 8, 2010
Date Started: March 2010
Date Completion:
Last Updated: July 20, 2011
Last Verified: May 2010
