Malaria, Falciparum Clinical Trial
Official title:
Chloroquine and Amodiaquine for Treatment of Symptomatic Children With Plasmodium Malaria in Guinea-Bissau
This study will evaluate the efficacy of the treatment recommended by the National Malaria Programme in Guinea-Bissau as compared to a higher dose of chloroquine and to another anti-malarial drug, amodiaquine. The genetic basis of the parasites for developing resistance will be examined. Children coming to Bandim Health Centre with symptoms of malaria and a positive malaria test will be included. The children will be visited and malaria films will be obtained weekly until day 35. In case of a reappearance of parasites the children will be re-treated with sulfadoxine/pyrimethamine.
Status | Completed |
Enrollment | 720 |
Est. completion date | May 2004 |
Est. primary completion date | May 2004 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 15 Years |
Eligibility |
Inclusion Criteria: - Patients < 15 years of age presenting at Bandim Health Centre - Symptoms suggestive of malaria - At least 20 P. falciparum parasites per 200 leukocytes in a thick film - Live in Bandim (to enable follow-up) Exclusion Criteria: - Severely ill children considered needing the services of a hospital by the medical doctor in charge - Stated medication with other antimalarials within one week prior to treatment - Previous idiosyncratic reactions to any of the study drugs |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Guinea-Bissau | Bandim Health Project | Apartado 861 | Bissau |
Lead Sponsor | Collaborator |
---|---|
Bandim Health Project |
Guinea-Bissau,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Parasite reappearance rate | |||
Primary | hospitalization during follow-up | |||
Secondary | Genetic markers in parasites | |||
Secondary | recrudescence rate | |||
Secondary | re-infection rate |
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