Efficacy of Artesunate + Amodiaquine Four Years After Its Introduction in Zanzibar
Study Details
Study Description
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 hypothesis is that the treatment has a polymerase chain reaction (PCR)adjusted parasitological cure rate of at least 85% 42 days after treatment.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Outcome Measures
Primary Outcome Measures
- PCR adjusted parasitological cure rate by day 42. []
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age below 60 months
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Weight ≥5kg
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No general danger signs or severe malaria present (see 4.4.2.1 & 4.4.2.2)
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History of fever within 24 hours OR axillary temperature ≥ 37.5Cº
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No other cause of fever is detectable
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No severe malnutrition
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Presence of P. falciparum asexual parasite density between 2000- 200,000/ul
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Guardian/Patient has understood the procedures of the study and is willing to participate
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Patient able to come for stipulated follow up visits and has easy access to the Study Site
Exclusion Criteria:
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Not able to drink or breastfeed
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Persistent Vomiting
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Recent history of convulsions
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Lethargic or unconscious
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Unable to sit or stand (as appropriate for age)
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History of allergy to test drugs
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History of intake of any drugs other than paracetamol and aspirin within 3 days
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kivunge Cottage Hospital | Kivunge | North A District, Zanzibar | Tanzania |
Sponsors and Collaborators
- Karolinska University Hospital
Investigators
- Study Director: Anders Björkman, Professor, Karolinska UH
- Principal Investigator: Guida Rotlland, MD, MPH, Karolinska UH
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ACOIII