A phase IV randomised study to assess the tolerability of artesunate-amodiaquine (AS-AQ) (Winthrop® fixed dose combination [FDC]) and artemether-lumefantrine for the treatment of uncomplicated falciparum malaria in Liberia

Not Applicable

Completed

• Conditions: Malaria; Infections and Infestations; Plasmodium falciparum malaria

• Registration Number: ISRCTN40020296
• Lead Sponsor: Drugs for Neglected Diseases initiative (DNDi) (Switzerland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-09
• Last Update Posted: 24 April 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

1. Aged greater than or equal to 6 years, either sex
2. Weight greater than or equal to 18 kg
3. Symptoms of malaria defined as fever (axillary temperature greater than or equal to 37.5°C), or history of fever in previous 48 hours
4. Microscopic confirmation of asexual stages of P. falciparum or mixed infection
5. Willingness to attend for follow-up
6. Signed informed consent by patient or responsible caregiver

Exclusion Criteria

1. Pregnancy (pregnancy test to be performed in women of childbearing age)
2. Severe malaria
3. AS-AQ or AL treatment at appropriate dose or more than two doses of another antimalarial in the previous 4 weeks
4. Known hypersensitivity to artemisinin derivates or amodiaquine, or artemether-lumefantrine
5. Severe anaemia (less than 5 g/dl haemoglobin)
6. Concomitant febrile illness if additional medication is required other than antipyretics

Study & Design

• Study Type: Interventional
• Study Design: Not specified