RecruitingPhase 3Phase 4ACTRN12614000216617

Efficacy and safety of artemether-lumefantrine and dihydroartemisinin-piperaquine phosphate for the treatment of uncomplicated Plasmodium falciparum malaria, and chloroquine for Plasmodium vivax in Ta Beik Kyin Township, Mandalay Region and dihydroartemisinin-piperaquine phosphate for the treatment of uncomplicated Plasmodium falciparum malaria in Ta-mu township, Sagaing Region

A study evaluating the efficacy and safety of artemether-lumefantrine and dihydroartemisinin-piperaquine phosphate for the treatment of uncomplicated Plasmodium falciparum malaria and chloroquine for plasmodium vivax malaria in in Ta Beik Kyin Township, Mandalay Region and Ta-mu township, Sagaing Region, Myanmar


Sponsor

Department of Medical Research (Upper Myanmar)

Enrollment

160 participants

Start Date

Jan 10, 2014

Study Type

Interventional

Conditions

Summary

To study the efficacy of antimalarial drugs in Myanmar


Eligibility

Sex: Both males and femalesMin Age: 6 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing the effectiveness of different antimalarial medicines in two regions of Myanmar. Researchers are looking at whether artemether-lumefantrine, dihydroartemisinin-piperaquine, and chloroquine work well against uncomplicated malaria in these areas, as part of ongoing drug resistance monitoring. You may be eligible if: - You are 6 years of age or older - You have been diagnosed with uncomplicated falciparum or vivax malaria by blood test - You have a fever or had one in the past 24 hours - You can swallow oral medication - You are willing to follow the study schedule You may NOT be eligible if: - You have severe malaria - You are severely malnourished - You are pregnant or breastfeeding (for falciparum malaria) - You have a serious illness such as heart, kidney, or liver disease, or HIV/AIDS - You are taking other medications that could interfere with malaria treatment - You have had an allergic reaction to the study medicines Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

For Plasmodium falciparum: The first 80 patients will receive Artemether-Lumefantrine (in a fixed combination of 20 mg of artemether and 120 mg of lumefantrine in a tablet) will be administered orall

For Plasmodium falciparum: The first 80 patients will receive Artemether-Lumefantrine (in a fixed combination of 20 mg of artemether and 120 mg of lumefantrine in a tablet) will be administered orally in a twice daily dose for three days, as follows: One tablet to those weighing 5-14kg; two tablets to children with 15-24 kg and three tablets to children weighing 25-35 kg. Four tablets to those over 35kg. The full course of treatment for all study patients consists of 6-doses given twice daily. The next 80 patients will be administered dihydroartemisinin-piperaquine. A fixed dose of 40 mg dihydroartemisinin and 320 mg piperaquine phosphate) will be administered orally as a weight per dose regimen of 2.25 and 18 mg/kg per dose of dihydroartemisinin and piperaquine phosphate. The medicine will be given a daily dose over three days. For plasmodium vivax: Chloroquine phosphate 150 mg base per tablet will be given a total dose of 25 mg per kg. body weight as: 10 mg per kg body weight for days 1 and 2 while 5 mg per kg body weight on day 3. All drug administration is supervised over the period of three days.


Locations(2)

Ta Beik Kyin Township, Mandalay Region, Myanmar

Ta-mu township, Sagaing Region, Myanmar

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ACTRN12614000216617


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