RecruitingPhase 3Phase 4ACTRN12614000214639

Efficacy and safety of Dihydroartemisinine-piperaquine for the treatment of uncomplicated Plasmodium falciparum malaria, and chloroquine for Plasmodium vivax in Homalin (Sagaing Division), Lashio (Shan State) and Bokepyin (Tanintharyi Division).

A study evaluating the efficacy and safety of Dihydroartemisinine-piperaquine for the treatment of uncomplicated plasmodium falciparum malaria, and chloroquine for plasmodium vivax in Homalin (Sagaing Division), Lashio (Shan State) and Bokepyin (Tanintharyi Division)


Sponsor

Clinical Research Unit (malaria), Defense Services General Hospital

Enrollment

200 participants

Start Date

Jan 1, 2014

Study Type

Interventional

Conditions

Summary

To study the efficacy of antimalarial drugs in Myanmar.


Eligibility

Sex: Both males and femalesMin Age: 13 Yearss

Plain Language Summary

Simplified for easier understanding

This study is measuring how well standard malaria medicines work in Myanmar. Researchers are checking whether the drugs dihydroartemisinine-piperaquine (for falciparum malaria) and chloroquine (for vivax malaria) are still effective at treating uncomplicated malaria infections in several regions of Myanmar. You may be eligible if: - You are 13 years old or older (females aged 13–17 have specific criteria — check with study staff) - You have been diagnosed with uncomplicated falciparum or vivax malaria by blood test - You have a fever or had a fever in the past 24 hours - You can swallow tablets - You are willing to follow the study schedule You may NOT be eligible if: - You have severe malaria - You are pregnant or breastfeeding - You have a serious illness such as heart, kidney, or liver disease, or HIV/AIDS - You are taking other medications that could interfere with antimalarial drugs - You have had an allergic reaction to the study medicines - You are unable or unwilling to use contraception or take a pregnancy test 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

All patients are over 13 years of age. For patients with plasmodium falciparum malaria dihydroartemisinin-piperaquine will be administered 2-2.4/16-19.2 mg/kg (Body weight will be recorded on day 0 to

All patients are over 13 years of age. For patients with plasmodium falciparum malaria dihydroartemisinin-piperaquine will be administered 2-2.4/16-19.2 mg/kg (Body weight will be recorded on day 0 to the nearest kilogram on a Salter scale. Patients should not wear excessive clothing while being weighed as this can overestimate their true weight. The screening weight will be used to satisfy the inclusion or exclusion for nutrition status as well as to calculate the dose (number of tablets) to be administered) once a day orally for 3 days. Less than 18 kgs will be given one tablet per day. Less than 29 kgs will be given 1 and a half tablets per day, less than 39 kgs will be given 2 tablets per day and over 40 Kgs will be given three tablets per day. Each tablet contains 40mg dihydroartemisinin and 320mg piperaquine phosphate. For patients with P. vivax malaria will be administered with chloroquine 10 mg, 10 mg and 5 mg per kg orally on day 0, 1 and 2 respectively. Enrolled patients will be observed for at least 30 min after treatment to ensure that they do not vomit the medicine. If vomiting occurs within 30 min of treatment, the full treatment dose will be repeated. Thereafter, patients are required to undergo regular clinical reassessment. Blood films for parasite counts will be made on days 2, 3 and 7 and then weekly for the remainder of the follow-up period, i.e. on days 14, 21, 28.


Locations(3)

Lashio (Shan State), Myanmar

Bokepyin (Tanintharyi Division), Myanmar

Homalin (Sagaing Division), Myanmar

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ACTRN12614000214639


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