Comparison of Two Regimens of Artemether-lumefantrine for the Treatment of Malaria in Pregnancy (ALN5P)
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|ClinicalTrials.gov Identifier: NCT01916954|
Recruitment Status : Completed
First Posted : August 6, 2013
Last Update Posted : March 26, 2014
|Condition or disease||Intervention/treatment||Phase|
|Malaria||Drug: 3-day artemether-lumefantrine Drug: 5-day artemether-lumefantrine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||96 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of Two Regimens of Artemether-lumefantrine for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Pregnant Women in the Democratic Republic of Congo|
|Study Start Date :||July 2013|
|Actual Primary Completion Date :||March 2014|
Active Comparator: 3-day artemether-lumefantrine
Standard artemether-lumefantrine regimen (3-day treatment)
|Drug: 3-day artemether-lumefantrine|
Experimental: 5-day artemether-lumefantrine
Artemether-lumefantrine extended regimen (5-day treatment)
|Drug: 5-day artemether-lumefantrine|
- Pharmacokinetics measures [ Time Frame: 1 year ]Drug plasma concentration profiles for lumefantrine, artemether and dihydroartemisinin will be characterized for each patient. Ten samples per patient will be taken at fixed and random times.
- Tolerability and safety measures [ Time Frame: 2 years ]Detection and assessment of adverse events during the therapy and in the follow-up period.
- Efficacy measures [ Time Frame: 1 year ]Therapeutic efficacy of the treatment will be assessed in the follow-up period according to WHO protocol for the evaluation of antimalarial efficacy. Therapeutic responses will be correlated with drug concentration profiles.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01916954
|University of Kinshasa, Democratic Republic of Congo|
|Principal Investigator:||Nicholas P Day, MD PhD||University of Oxford|