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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: |
NCT02089841 |
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Date of registration:
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15/03/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy of Artemether/Lumefantrine for the Treatment of Uncomplicated Malaria.
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Scientific title:
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Efficacy of Artemether/Lumefantrine for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Children Five Years After Wide Scale Use of the Drug in Tanzania. |
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Date of first enrolment:
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May 2012 |
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Target sample size:
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140 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02089841 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: 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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Tanzania
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Contacts
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Name:
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Andreas Martensson, 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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Karolinska Institutet |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Mono-infection with P. falciparum
- Parasitaemia level of 2000 - 200,000/µL
- Absence of danger signs or signs of severe malaria
- Axillary temperature = 37.5°C or history of fever 24 hours prior to coming to the
facility
- Absence of other concomitant infections like pneumonia which can cause fever
- No use of antimalarial drug two weeks prior to the study
- Consent to comply to the protocol.
Exclusion Criteria:
- Presence of general danger signs or signs of severe falciparum malaria
- Severe malnutrition
- Febrile condition due to diseases other than malaria, such as measles, acute lower
respiratory infection or other known chronic diseases
- Regular medication which might interfere with antimalarial pharmacokinetics
- History of hypersensitivity reactions or contraindications to any medicine being used
in the trial.
Age minimum:
6 Months
Age maximum:
120 Months
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Plasmodium Falciparum Malaria
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Intervention(s)
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Drug: Artemether-lumefantrine
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Primary Outcome(s)
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Proportion of patients without parasitaemia on day 42.
[Time Frame: 42 Days]
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Secondary Outcome(s)
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Plasma lumefantrine concentration
[Time Frame: 7 days and 14 days]
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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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