Tolerability and Efficacy of Artemether-Lumefantrine Versus Artesunate + Amodiaquine in Zanzibar

• Status: Completed
• Trial end date: 2003-02-17
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of the study was to determine PCR corrected cure-rates up to day 42 in children with uncomplicated malaria, treated with either Artesunate + Amodiaquine or Coartem®.

Secondary objectives were to determine safety and possible selection of mutations related to the resistance of the tested drugs.

• Phase: Phase 4

Details

• Lead Sponsor: Professor Anders Björkman
• Collaborators: World Health Organization; Zanzibar Malaria Control Programme
• Treatments: Amodiaquine; Artemether; Artemether-lumefantrine combination; Artemether, Lumefantrine Drug Combination; Artemisinins; Artesunate; Lumefantrine

Criteria

Inclusion Criteria:

• Children age 6-59 months and body weight ≥6 kg (AQ+AS); 9-59 months and body weight ≥9 kg (AL)

• Fever or history of fever in the preceding 24 hours

• Parasitemia ≥2000 ≤200.000 parasites per µl

• Informed consent given by the child's parent or other adult guardian

Exclusion Criteria:

• Signs of severe malaria or other danger signs, such as: 1.Unconsciousness; 2. Not able to sit or stand; 3.Severe anaemia (Hb ≤ 5 g/dl); 4.Convulsions; 5. Shock (systolic BP<50 mmHg); 6. Not able to drink or breastfeed; 7. Vomiting 3 times or more the past 24 hrs

• Other diseases associated with fever

• History of allergy to test drugs

• History of intake of any drugs other than paracetamol and aspirin within 3 days