Efficacy and Safety of Amodiaquine and Amodiaquine-Artesunate

• Status: Unknown status
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the efficacy and safety of two antimalarial drug regimes, namely amodiaquine versus amodiaquine-artesunate, in the treatment of children with uncomplicated malaria. Also, genetic host factors which might influence efficacy and/or safety will be examined.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Charite University, Berlin, Germany
• Collaborators: Kintampo Health Research Centre, Ghana; University for Development Studies, Tamale, Ghana
• Treatments: Amodiaquine; Artemisinins; Artesunate

Criteria

Inclusion Criteria:

• Male and female outpatients aged 6 to 59 months

• Body weight >5 kg

• Uncomplicated Plasmodium falciparum malaria

• Mono-infection with P. falciparum with an asexual parasite density between 2,000 to 200,000 parasites/μl

• Axillary temperature ≥37.5°C

• Ability to tolerate oral therapy

• Informed consent by the legal representative of the subject

• Residence in study area

Exclusion Criteria:

• Previous participation in this clinical trial

• Haemoglobin <5 mg/dl

• Mixed plasmodial infection

• Danger signs (unable to drink; repeated vomiting; recent history of convulsions;lethargic or unconscious state; unable to stand up or to sit) and signs of severe malaria as defined by WHO.

• Any other severe underlying disease (cardiac, renal, hepatic diseases, malnutrition, known HIV infection)

• Concomitant disease masking assessment of response

• History of allergy or intolerance against study medications