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

• Status: Suspended
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Karolinska University Hospital
• Treatments: Amodiaquine; Artemisinins; Artesunate

Criteria

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