Efficacy of Artesunate + Amodiaquine Versus Artemether-lumefantrine for Falciparum Malaria in Zanzibar, 2005

• Status: Completed
• Trial end date: 2005-07-11
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of the study was to determine the PCR-APCR up to day 42 in children <60 months of age, weighing ≥5kg with uncomplicated malaria, treated with either artesunate+ amodiaquine (ASAQ) or artemether-lumefantrine (AL; Coartem®).

Secondary objectives included: clinical and laboratory assessment of drug tolerability and safety, evaluation of possible correlation between drug bioavailability and clinical outcome, comparison of efficacy data with the pre-implementation "ACO I" study, parasite and fever clearance, gametocyte carriage, and possible selection of mutations related to quinoline resistance.

• Phase: Phase 4

Details

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

Criteria

Inclusion Criteria:

• Weight ≥5kg

• No general danger signs or severe malaria present (see 4.4.2.1 & 4.4.2.2)

• History of fever within 24 hours OR axillary temperature ≥ 37.5Cº

• No other cause of fever is detectable

• No severe malnutrition

• Patient has parasite counts between 2000-200,000/ul (50-5000/200 white blood cells)

• Guardian/Patient has understood the procedures of the study and is willing to participate

• Patient able to come for stipulated follow up visits and has easy access to the Study Site

Exclusion Criteria:

General Danger Signs and Complications:

• Not able to drink or breastfeed

• Vomiting everything

• Recent history of convulsions

• Lethargic or unconscious

• Unable to sit or stand (as appropriate for age)

• History of allergy to test drugs

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

Signs of Severe Malaria:

• Altered consciousness

• Repeated convulsions

• Inability of oral intake

• Severe anaemia (Hb <5gm/dl)

• Difficulty in breathing (pulmonary oedema, Respiratory Distress Syndrome)

• Shock (small pulse, cold extremities)

• Hypoglycaemia

• Haemoglobinuria (dark coloured urine or Coca-Cola urine)

• Kidney failure (little or no urine in a well-hydrated patient)

• Jaundice (yellow colouring of eyes)

• Hyperpyrexia (temperature above 39.5ºC) in combination with other signs

• Hyperparasitaemia (more than 5% red blood cells parasitized or >200,000 parasites/µl)

• Spontaneous bleeding (Disseminated Intravascular Coagulation)