Efficacy of Artemether/Lumefantrine for the Treatment of Uncomplicated Malaria. (ALE)
|ClinicalTrials.gov Identifier: NCT02089841|
Recruitment Status : Completed
First Posted : March 18, 2014
Last Update Posted : March 18, 2014
|Condition or disease||Intervention/treatment||Phase|
|Plasmodium Falciparum Malaria||Drug: Artemether-lumefantrine||Phase 4|
Artemisinin based combination therapies (ACTs) are currently recommended by the World Health Organization (WHO) as first-line treatment for uncomplicated malaria in all malaria endemic countries including Tanzania, that adopted the policy in 2007. ACTs have proven to be highly efficacious in different parts of the world with different malaria endemicity. Artemisinins clear asexual parasites rapidly and they are also potent against P. falciparum gametocytes, hence reducing disease transmission and spread of drug resistance. Nonetheless, a report in Kenya shows an increase in proportion of patients with parasitaemia on day 1. Most recently, resistance against artemisinins has been confirmed in four countries of South-East Asia, and it may spread to Africa.
In order to safeguard ACTs life span, WHO recommends all suspected malaria cases to be confirmed with parasitological diagnosis, followed by prompt treatment with effective antimalarials. It also emphasizes on the need to conduct efficacy studies for the first and second line antimalarial treatments after every two years so as to be able to detect resistance early on its course. Therefore, based on this notion, this study aimed to assess the therapeutic efficacy of Artemether/Lumefantrine among children with uncomplicated falciparum malaria in Bagamoyo district, five years after its wide scale use in Tanzania.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||140 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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.|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||August 2013|
In this single-arm study, patients will be treated with Artemether/lumefantrine, and the first, third and fifth doses of the drug will be given under the direct observation of the health workers. The patients will be followed-up for 42 days, on day 1, 2, 3, 7, 14, 21, 28 and 42 to assess the efficacy of the drug.
Blood samples will be collected on blood slides and filter papers for asexual parasites assessment both by microscope and molecular genotyping respectively following treatment with artemether-lumefantrine, to assess its efficacy.
Other Name: Coartem
- Proportion of patients without parasitaemia on day 42. [ Time Frame: 42 Days ]Proportion of patients without parasitaemia or with new infection as corrected by molecular genotyping on day 42 will be used to calculate the efficacy of the trial medicine.
- Plasma lumefantrine concentration [ Time Frame: 7 days and 14 days ]Mean plasma lumefantrine concentration among patients on day 7 and day 14 following treatment with artemether/lumefantrine as a predictor of cure rate.
- Proportional of patients without parasitaemia on day 42 [ Time Frame: 42 days ]Proportion of patients without parasitaemia on day 42 as purely assessed by molecular genotyping of all collected samples on this day, differentiate between recrudescence and new infection and use it to calculate the efficacy of the trial medicine.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02089841
|Muhimbili University of Health and Allied Sciences|
|Dar es Salaam, Tanzania, P.O Box 65001|
|Study Director:||Andreas Martensson, PhD||Karolinska Institutet|