Single-dose malaria treatment as effective as multi-dose regimen, trial shows

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Hundreds of malaria patients enrolled in a phase 3 clinical trial in Gabon, West Africa, were successfully treated with a one-time therapy that combines four commonly used malaria drugs, according to a new study presented yesterday at the American Society of Tropical Medicine and Hygiene.

For this pragmatic, randomized, comparative study, a team led by researchers at the Medical Research Center of Lambarene and the Institute of Tropical Medicine in Germany's University of Tubingen treated more than 1,000 people diagnosed as having uncomplicated malaria, or those who were sick but not yet having life-threatening symptoms.

Slightly more than half the participants (539) received a single-dose regimen composed of four different malaria drugs. The remaining participants (442) received a widely used malaria treatment that combines two drugs and requires six doses over three days.

At day 28, blood tests showed that 93% of people who received the single-dose treatment were free of parasites, compared with 90% of those who received the three-day treatment. No serious adverse effects were noted in any patients.

"We found that our single-dose treatment was just as effective as the standard course that typically requires taking six doses spaced out over three days, which many patients never complete," said lead author Ghyslain Mombo-Ngoma, MD, PhD, in the news release.

Urgent need for new ways to treat malaria patients

The need to find new ways to treat malaria is pressing, the authors said. After falling from 2000 to 2015, malaria infections and deaths have increased significantly.

We found that our single-dose treatment was just as effective as the standard course that typically requires taking six doses spaced out over three days, which many patients never complete.

Ghyslain Mombo-Ngoma, MD, PhD

According to the World Health Organization, there were 216 million cases and 445,000 deaths from malaria in 2016. In 2023, there were 263 million cases and 597,000 deaths. Most malaria infections and deaths occur in children under age 5 years.

Artemisinin combination therapies (ACTs), once a cornerstone in the fight against malaria, are increasingly challenged by partially drug-resistant parasites, which have stalled progress against the disease in recent years. This is because over a third of patients do not complete a multi-day course of treatment, which encourages drug resistance and allows curable cases to get worse.

Drugs available in Africa, relatively affordable

The four drugs that make up the single-dose therapy are relatively affordable and available in Africa, notes Mombo-Ngoma. Researchers in Mali, Ghana, Kenya, and Mozambique have also shown interest in testing the single-dose approach, and discussions are in progress with a drug manufacturer to produce single-dose capsules.

But, Mombo-Ngoma cautions, while a single-dose therapy offers hope against drug-resistant parasites, it will take several years for the most advanced compounds to become widely available across the continent.

"What I hope is that, if we continue to have success with the single-dose cure, it can serve as a bridge to the new treatments now under development—something we can deploy very soon while we await the arrival of other options," he says.