RecruitingPhase 2ACTRN12610000546055

A pilot study comparing the efficacy of artesunate alone and artesunate plus azithromycin for the treatment of Plasmodium falciparum malaria in central Vietnam

A pilot study comparing the efficacy and tolerability of artesunate alone and artesunate plus azithromycin for the treatment of Plasmodium falciparum malaria in central Vietnam


Sponsor

Australian Army Malaria Institute

Enrollment

60 participants

Start Date

May 17, 2010

Study Type

Interventional

Conditions

Summary

Artemisinin-based combination treatments (ACT) are now recommended as first-line treatment for Plasmodium falciparum malaria worldwide. Recent studies have shown reduce susceptibility of artesunate in western Cambodia and thus there is an urgent need to know whether artesunate resistance is present in neighbouring Southeast Asian countries such as Vietnam. In this study, we propose to assess whether reduce susceptibility exists at a commune in central Vietnam by giving patients a 7 day course of artesunate alone. At the same time, we will evaluate the efficacy of the ACT, artesunate plus azithromycin as this combination is meant to be safe in special risk groups such as young children and during pregnancy. However, before testing the artesunate plus azithromycin in special risk groups we need to know that the ACT is efficacious in the general population between 5 and 65 years.


Eligibility

Sex: Both males and femalesMin Age: 5 YearssMax Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing two malaria treatments in central Vietnam: a 7-day course of artesunate alone, and a combination of artesunate plus azithromycin. Researchers want to know if drug-resistant malaria exists in Vietnam, and whether the combination treatment is effective and safe — especially because it may eventually be used in high-risk groups like children and pregnant women. You may be eligible if: - You are between 5 and 65 years old - You have been diagnosed with falciparum malaria with a specific level of parasites in your blood - You are willing to provide small blood samples and attend follow-up visits for 28 to 42 days You may NOT be eligible if: - You have severe or cerebral malaria or another serious medical condition - You have taken an artemisinin drug in the past 7 days - You are pregnant or breastfeeding - You have difficulty communicating with researchers due to mental health or language barriers 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

Malaria patients will be given either artesunate alone (4 mg/kg on the first day of treatment then 2 mg/kg daily for 6 days) or artesunate (4 mg/kg) plus azithromycin (20 mg/kg) daily for 3 days for t

Malaria patients will be given either artesunate alone (4 mg/kg on the first day of treatment then 2 mg/kg daily for 6 days) or artesunate (4 mg/kg) plus azithromycin (20 mg/kg) daily for 3 days for the treatment of uncomplicated falciparum malaria. The mode of administration will be by the oral route.


Locations(1)

Viet Nam

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ACTRN12610000546055