There is one clinical trial.
Artemisinin combination therapy (ACT) with artemether lumefantrine (AL) is currently the
first line treatment policy in Tanzania. AL is an efficacious drug that also has the capacity
to reduce malaria transmission to mosquitoes. Nevertheless, there is concern about the
development of parasite resistance against AL and there have been very few clinical trials
that compared different ACT regimens. A recent clinical trial shows that the combination of
dihydroartemisinin-piperaquine (DP) may be more efficacious than AL and may have a more
pronounced beneficial effect on post-treatment malaria transmission. Screening for molecular
markers that are related to parasite susceptibility to ACT drugs and to post-ACT treatment
malaria transmission can assist in preventing the development and spread of ACT resistance.
In the current study, the investigators compared AL and DP for the treatment of uncomplicated
malaria. The investigators endpoints are
- clinical efficacy
- post-treatment gametocytaemia by molecular techniques
- post-treatment malaria transmission.
NCT00868465 Conditions
- Uncomplicated Malaria
Interventions
- Drug: Artemether-Lumefantrine
- Drug: Dihydroartemisinin-piperaquine
This resistance was associated with SNPs at codon S769N of the ATPase6
locus of P. falciparum. --- S769N ---
Primary Outcomes
Measure: To determine the clinical efficacy of artemether-lumefantrine (AL) and dihydroartemisinin-piperaquine (DP) in the treatment of uncomplicated falciparum malaria in children living in north-western Tanzania and in western Kenya. Time: during 42 day follow-up
Secondary Outcomes
Measure: To determine (sub-microscopic) gametocyte carriage after treatment with AL and DP Time: during 42 day follow-up
Measure: To determine malaria transmission to mosquitoes after treatment with AL or DP Time: day 7 after initiation treatment
Measure: To determine molecular markers that are predictive of reduced susceptibility of parasite strains for AL and DP Time: day 7 after initiation treatment
Measure: To determine molecular markers that are related to gametocytaemia or malaria transmission after treatment with AL and DP Time: during 42 day follow-up
Measure: To determine the relation between treatment success and the presence of anti-malaria antibodies Time: during 42 day follow-up
Measure: To explore the role of cellular oxidative stress in treatment with AL and DP Time: during 42 day follow-up
Measure: To determine the relation between transmission to mosquitoes and the presence of anti-malaria antibodies Time: day 7 after initiation treatment