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Main
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Note: This record shows only 22 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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19 February 2015 |
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Main ID: |
NCT01814423 |
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Date of registration:
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16/03/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Pharmacokinetic Study of Multi-dose Chloroquine
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Scientific title:
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Pharmacokinetic Study of Multi-dose Chloroquine |
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Date of first enrolment:
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April 2013 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01814423 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Guinea-Bissau
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Contacts
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Name:
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Poul-Erik Kofoed, Ph.d |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bandim Health Project |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age = 2 years and < 10 years.
- Mono-infection with P. falciparum detected by microscopy. Parasitemia of
1.000-100.000/µl asexual forms.
- Axillary temperature = 37.5 °C or a history of fever within 24 hours.
- Ability to swallow oral medication.
- Ability and willingness to comply with the study protocol.
- Informed consent from a parent or guardian
Exclusion Criteria:
- Signs or symptoms of severe malaria.
- Presence of general danger signs in children under 5.
- Persistent vomiting.
- Presence of severe malnutrition.
- Any evidence of chronic disease or acute infection other than malaria.
- Regular medication which may interfere with antimalarial pharmacokinetics.
- History of hypersensitivity reactions or contraindications to chloroquine.
Age minimum:
2 Years
Age maximum:
9 Years
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: Chloroquine-base 70 mg
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Drug: Chloroquine-base 50 mg
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Primary Outcome(s)
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Chloroquine serum concentration
[Time Frame: Twice daily during treatment, on day 1 an additional 8 measurements.]
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Secondary Outcome(s)
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Parasitemia
[Time Frame: Twice a day dúring treatment and then weekly until day 28.]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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