Efficacy of Artesunate + Amodiaquine Four Years After Its Introduction in Zanzibar

Karolinska University Hospital

Status and phase: Suspended; Phase 4

Conditions: Malaria

Treatments: Drug: artesunate + amodiaquine

Study type: Interventional

Funder types: Other

Identifiers

NCT00465257

ACOIII

Details and patient eligibility

About

The purpose of this study is to assess the efficacy of artesuante + amodiaquine four years after its introduction as first line treatment for uncomplicated childhood malaria in Zanzibar. The hypothesis is that the treatment has a polymerase chain reaction (PCR)adjusted parasitological cure rate of at least 85% 42 days after treatment.

Enrollment: 110 estimated patients

Sex: All

Ages: 6 to 59 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age below 60 months
• 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
• Presence of P. falciparum asexual parasite density between 2000- 200,000/ul
• 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

• Not able to drink or breastfeed
• Persistent Vomiting
• 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