Clinical Trial: Randomised Efficacy Study of Two Artemether-Lumefantrine Oral Formulations for the Treatment of Uncomplicated P. Falciparum Malaria
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomized Open-Label Trial of the Efficacy of Artemether-Lumefantrine Suspension Compared With Artemether-Lumefantrine Tablets for the Treatment of Uncomplicated Plasmodium Fa
Brief Summary: The purpose of this study is to compare the safety and efficacy in children aged 6 - 59 months with uncomplicated malaria, treated with either conventional artemether/lumefantrine tablets(Coartem®) or artemether/ lumefantrine suspension (Co-artesiane®) in Western Kenya
Detailed Summary:
Sponsor: Dafra Pharma
Current Primary Outcome: To compare PCR corrected cure-rates on day 14 and 28 [ Time Frame: 1 year ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- To determine and compare Adequate Clinical and Parasitological Response (ACPR) at days 14 and 28 [ Time Frame: 28 days ]
- To determine and compare proportion of children with gametocytes on days 0, 7, 14, and 28 [ Time Frame: 28 days ]
- Monitor any possible adverse reactions following use of both drugs [ Time Frame: 28 days ]
Original Secondary Outcome: Same as current
Information By: Dafra Pharma
Dates:
Date Received: September 12, 2007
Date Started: May 2007
Date Completion:
Last Updated: January 17, 2008
Last Verified: January 2008
