NCT00540202

Effectiveness of Oral Quinine and Artemether-Lumefantrine in the Treatment of Uncomplicated Malaria in Ugandan Children

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 302 (estimated)
• Sponsor: Makerere University · Academic / Other
• Sex: All
• Age: 6 Months – 5 Years
• Healthy volunteers: Not accepted

Summary

We will test the hypothesis that there is a difference in effectiveness of oral quinine in comparison to artemether Lumefantrine in the treatment of uncomplicated malaria in children.

Detailed description

This study will be designed as an open randomized effectiveness study assessing the parasitological and clinical cure rates and adherence to oral quinine monotherapy in comparison to artemether-Lumefantrine. We will also describe some of the adverse events to the two drugs.The measurements will include age, sex, weight, hemoglobin levels on days 0, 7, 14 and 28, parasite density on days 0, 7, 14 and 28 and clinical examination findings. Adverse events will also be documented

Conditions

• Uncomplicated Malaria

Interventions

Type	Name	Description
DRUG	artemether-lumefantrine	Tablets taken twice daily for 3 days according to weight based guidelines.
DRUG	Oral quinine	Quinine tablets given at 10mg/kg 8 hourly for 7 days

Timeline

• Start date: 2007-09-01
• Completion: 2008-04-01
• First posted: 2007-10-05
• Last updated: 2007-10-05

Locations

1 site across 1 country: Uganda