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ATOVAQUONE

Clinical trials investigating ATOVAQUONE are studying its use in malaria prevention. This article summarizes a Phase 2 study in healthy, non-immune volunteers to measure how well a weekly oral atovaquone-proguanil regimen protects against malaria and to assess safety.

Table of Contents

Trial overview

This clinical research is studying ATOVAQUONE in a malaria prevention setting.[1] The provided trial is a Phase 2 interventional study with the title “Antimalarial prophylactic efficacy of a weekly dose atovaquone-proguanil.”[1]

The study status is Authorised, and the planned enrollment is 32 participants.[1] The trial is focused on whether weekly oral atovaquone-proguanil can protect people from malaria after controlled exposure to the parasite.[1]

Who can participate

The study is designed for non-immune healthy volunteers.[1] This means the volunteers are healthy and do not already have protection against malaria.[1]

Because the study is testing prevention, the target group is not people with active malaria disease.[1] Instead, the trial looks at whether the study medicine can help prevent infection after exposure in a controlled research setting.[1]

What is being tested

The main preventive treatment being studied is oral atovaquone-proguanil, given as 250/100 mg weekly.[1] The trial title and summary both show that the study is evaluating the prophylactic, or preventive, effect of this regimen.[1]

The trial also includes PfSPZ Challenge (NF54), which is given by intravenous injection as part of the malaria challenge model.[1] A placebo-like capsule containing microcrystalline cellulose PH102 is also listed among the interventions.[1]

In simple terms, the study compares how people do after planned malaria exposure when they receive the preventive medicine.[1]

Trial phase and design

This is a Phase 2 study.[1] Phase 2 trials usually look more closely at whether a treatment works and continue to check safety in a smaller group of people.[1]

The study is interventional, which means the researchers assign study treatments and then measure the results.[1] The design uses a malaria challenge approach, where volunteers are exposed to PfSPZ Challenge NF54 so researchers can see whether the preventive regimen works.[1]

Outcomes being measured

The main efficacy outcome is the proportion of protected volunteers.[1] Protection is defined as no amplifying parasitaemia in the blood for 21 days after challenge exposure.[1]

Amplifying parasitaemia means the parasite level in the blood rises over time, based on qPCR testing.[1] The trial defines this as at least one qPCR result above 20 blood-stage parasites per mL, followed by another qPCR result showing at least a 4-fold increase 24 to 48 hours later.[1]

The primary safety endpoint is also listed, showing that the study is not only asking whether ATOVAQUONE-based prevention works, but also whether it can be studied safely in this volunteer group.[1]

Why this study matters

Malaria prevention studies help researchers test whether a medicine can stop infection before it starts.[1] This trial is important because it uses a controlled challenge model, which can give early evidence about protective effect in a small group of volunteers.[1]

The current data show one authorised Phase 2 study of ATOVAQUONE-related prevention in healthy, non-immune adults, with protection against malaria and safety as the main goals.[1]

Trial ID Phase Condition studied Status Enrollment
2024-518884-36-00 Phase 2 Malaria prevention in non-immune healthy volunteers Authorised 32

FAQ

  • What is being studied in the ATOVAQUONE trial? The trial is studying whether a weekly oral atovaquone-proguanil regimen can protect healthy volunteers from malaria after controlled malaria exposure. It also measures safety.
  • Who can take part in this study? The study is in non-immune healthy volunteers. That means people who do not already have protection from malaria and who are otherwise healthy.
  • What phase is the ATOVAQUONE trial? This is a Phase 2 trial. Phase 2 studies usually look at whether a treatment works and continue to check safety.
  • What condition is this trial focused on? The trial focuses on malaria. It is testing prevention, not treatment of an active infection.
  • What results are the researchers measuring? The main result is the number of volunteers who are protected from malaria after challenge exposure. Protection is defined by no rising parasite levels in the blood during the follow-up period.

Ongoing Clinical Trials on ATOVAQUONE

  • Study on the Effectiveness of Atovaquone and Proguanil for Malaria Prevention in Healthy Volunteers

    Recruiting

    2 1 1
    Investigated drugs:
    Germany

Glossary

  • Malaria: A serious infection caused by parasites that are spread by mosquitoes. In this trial, researchers are studying ways to prevent it.
  • Non-immune: Not already protected against a disease. In this study, it means volunteers do not have natural protection against malaria.
  • Healthy volunteers: People who join a study and do not have the disease being studied. They are often used in prevention research.
  • Phase 2: A stage of clinical research that checks whether a treatment may work and continues to monitor safety.
  • Interventional study: A study where researchers give a treatment or other intervention and then measure the results.
  • Chemoprophylaxis: Using medicine to help prevent an infection before it starts.
  • Challenge exposure: A planned exposure used in research to see whether a preventive treatment works.
  • Parasitaemia: The presence of parasites in the blood. In this trial, researchers look for rising parasite levels.
  • qPCR: A lab test that can detect very small amounts of parasite genetic material in the blood.
  • Primary outcome: The main result the study is designed to measure.

References

  1. https://clinicaltrials.gov/study/2024-518884-36-00