Status:
SUSPENDED
Efficacy of Artesunate + Amodiaquine Four Years After Its Introduction in Zanzibar
Lead Sponsor:
Karolinska University Hospital
Conditions:
Malaria
Eligibility:
All Genders
6-59 years
Phase:
PHASE4
Brief 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 hypothesi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00465257
Start Date
May 1 2007
Last Update
May 20 2008
Active Locations (1)
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1
Kivunge Cottage Hospital
Kivunge, North A District, Zanzibar, Tanzania