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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: |
NCT02090036 |
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Date of registration:
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16/03/2014 |
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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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Efficacy and Safety of a Single Low-dose Primaquine for the Clearance of Gametocytes
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Scientific title:
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Efficacy and Safety of a Single Low-dose Primaquine Added to Standard Artemether-lumefantrine Treatment for the Clearance of Plasmodium Falciparum Gametocytes. |
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Date of first enrolment:
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July 2014 |
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Target sample size:
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220 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02090036 |
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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: Single Blind (Subject), Primary Purpose: Prevention
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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:
- Age of 1 year and above and neither pregnant nor breast feeding.
- Weight over 10 kg.
- Body temperature =37.5°C) or history of fever in the last 24 hours.
- P. falciparum mono-infection.
Exclusion Criteria:
- Evidence of severe illness malaria or danger signs.
- Known allergy to study medications.
- Hemoglobin <8 g/dl.
- Antimalarials taken within last 2 weeks.
- Blood transfusion within last 90 days and evidence of recent use (within 14 days)of
or will be taking other drugs known to cause hemolysis in G6PD deficient subjects.
Age minimum:
1 Year
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Plasmodium Falciparum
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Intervention(s)
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Drug: Primaquine (For artemether-lumefantrine+primaquine arm)
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Drug: Placebo (For artemether-lumefantrine arm)
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Primary Outcome(s)
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Number of days per treatment arm for gametocytes to become undetectable using Quantitative nucleic acid sequence based assay (QT-NASBA).
[Time Frame: 14 days]
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Secondary Outcome(s)
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Mean maximal fall in hemoglobin (g/dl) from enrolment to day 28 of follow-up defined as mean greatest negative difference in hemoglobin per treatment arm.
[Time Frame: 28 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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