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RecruitingPhase 3Phase 4ACTRN12614000217606

Monitoring the therapeutic efficacy of antimalarial medicines across International borders of India.

A study evaluating the efficacy and safety of artemether lumefantrine for the treatment of uncomplicated plasmodium falciparum infections in Lunglei district (Mizoram); Changlang district (Arunachal Pradesh), Gomati district or Dhalai district (Tripura) in India.

Sponsor

National Insititute of Malaria Research

Enrollment

70 participants

Start Date

Jan 10, 2014

Study Type

Interventional

Conditions

Malaria

Summary

To study the efficacy of antimalarial drugs in India

Eligibility

Sex: Both males and femalesMin Age: 1 YearsMax Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

This study is monitoring how well antimalarial medicines are working in different regions of India. Researchers are checking the effectiveness of these treatments in people with falciparum malaria to track whether any drug resistance is developing. You may be eligible if: - You are between 1 and 65 years of age - You have been diagnosed with falciparum malaria by blood test - You have a fever or had one in the past 48 hours - You can swallow oral medications - You and/or your guardian are willing to follow the study schedule and give informed consent You may NOT be eligible if: - You have severe malaria (especially children under 5 with danger signs) - You are severely malnourished - You are pregnant or breastfeeding - You have a serious illness such as heart, kidney, or liver disease, or HIV/AIDS - You are taking medications that could interfere with antimalarial drugs - You have had a serious 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

Artemether-lumefantrine will be administered orally twice daily to patients for 3 days. Adult patients (35kg and above) will receive dosage of 80 mg artemether and 480 mg lumefantrine twice daily for

Artemether-lumefantrine will be administered orally twice daily to patients for 3 days. Adult patients (35kg and above) will receive dosage of 80 mg artemether and 480 mg lumefantrine twice daily for 3 days. For patients from 25 to 35 kg the dosage is 60mg artemether and 360 mg of lumefantrine twice daily for 3 days. For patients from 15 to 25 kg the dosage is 40mg artemether and 240 mg of lumefantrine twice daily for 3 days. For patients from 5 to 15 kg the dosage is 20mg artemether and 120 mg of lumefantrine twice daily for 3 days. The first dose will be administered at the health centre by a study nurse or clinician. Every day morning doses of medicine on day 0, 1and 2 will be administered under the supervision of a qualified staff. The subsequent second dose on each day will be given at home by a parent or guardian and will be monitored by study personnel through mobile phone call or home visits if the parent/guardian is not reachable by mobile phone. All the doses will be administered after meals.

Locations(3)

Lunglei district (Mizoram), India

Changlang district (Arunachal Pradesh), bordering Myanmarh, India

Gomati or Dhalai districts (Tripura) bordering Bangladesh, India

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ACTRN12614000217606

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