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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00529620 |
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Date of registration:
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13/09/2007 |
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Primary sponsor: |
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Public title:
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Three Alternative Drug Regimens for Malaria Seasonal Preventive Treatment in Senegal
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Scientific title:
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Randomized Trial of Effectiveness and Acceptability of Three Alternative Regimens for Malaria Seasonal Intermittent Preventive Treatment in Senegal |
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Date of first enrolment:
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September 2007 |
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Target sample size:
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1833 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00529620 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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Countries of recruitment
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Senegal
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Contacts
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Name:
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Paul J Milligan, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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London School of Hygiene and Tropical Medicine |
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Name:
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Badara Cisse, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Universite Cheikh Anta Diop |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- age 2 to 59 months in September 2007
Exclusion Criteria:
- history of allergy to study drugs
Age minimum:
2 Months
Age maximum:
59 Months
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Malaria
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Intervention(s)
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Drug: dihydroartemisinin plus piperaquine
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Drug: sulfadoxine pyrimethamine plus piperaquine
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Drug: sulfalene-pyrimethamine plus amodiaquine
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Primary Outcome(s)
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Incidence of malaria
[Time Frame: Four months]
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Secondary Outcome(s)
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Adverse events reported by the mother: vomiting, headache, fever, nausea, diarrhea
[Time Frame: within 4 days of the start treatment]
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Compliance with the treatment regimen
[Time Frame: Recorded 4 days after the start of treatment]
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Haemoglobin concentration
[Time Frame: Measured 1 month after the last treatment, in December]
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Prevalence of P.falciparum parasitaemia
[Time Frame: Measured by microscopy 1 month after the last treatment, in December]
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The proportion of children carrying P.falciparum genotypes associated with resistance to sulfadoxine and pyrimethamine
[Time Frame: Measured in December]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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