NCT00465257SuspendedPhase 4
Efficacy of Artesunate + Amodiaquine Four Years After Its Introduction as New Treatment Policy for Uncomplicated Plasmodium Falciparum Malaria in Zanzibar
Karolinska University Hospital1 site in 1 country110 target enrollmentStarted: May 1, 2007Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Suspended
- Sponsor
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- PCR adjusted parasitological cure rate by day 42.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Masking
- None
Eligibility Criteria
- Ages
- 6 Months to 59 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
PCR adjusted parasitological cure rate by day 42.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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