Scientific research RaViCHMI1: Malaria research

Treatment

This is a controlled human malaria infection study - this means that as a participant you will be infected with malaria. As the name suggests, this is very well controlled, as a participant you will be seen regularly in the hospital and during the study the study doctor is available 24/7. In total, participants will receive two different treatments. The first treatment is effective against the stage of the malaria parasite that causes the symptoms. This drug has virtually no effect on the stage transmitted to the mosquito. This treatment starts when the parasites in the blood have reached a certain level or when the symptoms of the malaria infection begin to interfere with your daily activities. Which treatment you receive as a participant depends on the group you are in.

For this study, we will make 3 groups of 4 people:

• “Group Piperaquine”. The participants in this group will receive piperaquine, an antimalarial drug found in a commonly used anti-malarial drug.
• “Group Mepacrine”. Participants in this group will receive mepacrine, an antimalarial drug that has been widely used in the past.
• Group 3. The treatment of this group depends on the results of the previous two groups.

All participants will receive their second treatment at the end of the study, this is a widely used and very active antimalarial drug to ensure that they are completely cured at the end of the study. This drug kills all stages of the malaria parasite.

For whom?

Our target audience is healthy adults (mainly Radboud University students).

A number of conditions apply to participate in this study:

• You are 18-45 years old;
• You are in overall good health and make it through the health screening process;
• You have never had malaria and you have not been in a malaria endemic region in the past three months;
• You are willing to stay within two hours travel distance of the Radboudumc;
• You are reachable by phone 24/7;
• You can't use drugs or alcohol or take part in intense physical activity during the study;
• For women: you should not get pregnant during the study, for your own safety and that of the baby. Therefore, women who are at risk of becoming pregnant must agree to use contraception.

This is an overview of the most important conditions. For an overview of all conditions for participation contact the study team: clinicalmalariastudies.mmb@radboudumc.nl.

Study overview

The study will last a total of 53 days. Screening can take place up to 28 days before the start of the study. If you pass the screening and meet all inclusion and exclusion criteria, the study begins 3 days (Day -3) before you are infected with malaria (Day 0). You will be seen in the hospital the day after infection. Day 2 through 4 you will be contacted by phone. From Day 5 to Day 26 you must come to the hospital daily, this usually takes 10-60 min, some days longer. Part of this period you may experience (mild) symptoms of the malaria infection, you will then receive treatment against the stage of malaria parasite causing the symptoms. Around the time of receiving this treatment you may have a fever and feel sick, we expect this to last 24-48 hours at most. In addition, most of the tests, such as blood sampling and mosquito infections, will take place during this 20 day period. As a participant, on day 24 (at the latest) you will receive the end-of-study medication that will cure you completely of the malaria infection. After this, you will have to come to the hospital twice more on day 35 and 49, where we will check the absence of parasites.