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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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7 June 2021 |
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Main ID: |
NCT01704508 |
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Date of registration:
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09/10/2012 |
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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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Improving Anti-malarial Treatment Options in Guinea-Bissau - Part A
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Scientific title:
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Efficacy and Safety of Artemether + Lumefantrine and Dihydroartemisinin + Piperaquine for the Treatment of Uncomplicated Malaria in Guinea-Bissau. |
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Date of first enrolment:
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November 2012 |
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Target sample size:
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346 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01704508 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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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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Key inclusion & exclusion criteria
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Inclusion Criteria:
A) Age =6 months, and <13 years. B) Mono-infection with P. falciparum detected by
microscopy. C) Parasitemia of 1.000-200.000/µl asexual forms. D) Axillary temperature =37.5
°C or a history of fever within 24 hours. E) Ability to swallow oral medication.
F) Ability and willingness to comply with the study protocol for the duration of the study
and to comply with the study visit schedule. G) Informed consent from a parent or guardian
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Exclusion Criteria:
A) Signs or symptoms of severe malaria, incl. hyperparasitaemia (>200.000/ µl asexual
forms) B) Presence of general danger signs in children under 5 C) Presence of severe
malnutrition. D) Any evidence of chronic disease or acute infection other than malaria. E)
Regular medication which may interfere with antimalarial pharmacokinetics. F) History of
hypersensitivity reactions or contraindications to AL, DP or quinine.
G) Domicile outside the study area.
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Age minimum:
6 Months
Age maximum:
12 Years
Gender:
All
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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-piperaquine
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Drug: Artemether-lumefantrine
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Primary Outcome(s)
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Adequate clinical and parasitological response rate
[Time Frame: 42 days]
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Secondary Outcome(s)
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the safety of AL and DP
[Time Frame: 42 days]
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Secondary ID(s)
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Eurartesim-2012
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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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