ProjectSPARE – Optimizing Malaria Prophylaxis in Travellers: A Clinical Trial of Weekly Atovaquone Proguanil Dosing…
Basic data
Acronym:
SPARE
Title:
Optimizing Malaria Prophylaxis in Travellers: A Clinical Trial of Weekly Atovaquone Proguanil Dosing (SPARE)
Duration:
01/10/2025 to 31/03/2027
Abstract / short description:
Malaria remains a significant global health challenge, that also puts millions of international travellers at risk of a life-threatening infectious disease. The current standard for malaria prophylaxis in travellers involves daily oral chemoprophylaxis with atovaquone-proguanil. Given atovaquone-proguanil’s activity on hepatic stages of malaria parasites, a weekly regimen could potentially offer equivalent protection as a daily regimen, enhancing malaria prophylaxis coverage and reducing side effects and resources needed.
The primary objective of this study is to evaluate the prophylactic efficacy of a weekly oral atovaquoneproguanil regimen in non-immune healthy volunteers using a Controlled Human Malaria Infection (CHMI) model. Secondary objectives include assessing safety, tolerability, and pharmacokinetic
profiles of this regimen. This study will be a single-centre, randomized, placebo-controlled, single-blind clinical trial.
Participants will receive weekly oral atovaquone-proguanil (250/100 mg) and undergo CHMI with PfSPZ Challenge (NF54). The study will evaluate the efficacy of atovaquone-proguanil administered at different intervals relative to malaria exposure, simulating real-world scenarios. Leveraging the expertise and infrastructure of the Institute of Tropical Medicine (ITM) Tübingen, this study builds on a solid foundation of clinical trial capacity and malaria research. This study specifically strives for optimization of antimalarial chemoprophylaxis in travellers and thereby complements the ITM’s clinical trials portfolio on antimalarial prevention by vaccine development targeting populations in endemic regions. This study proposes a significant paradigm shift away from current daily dosing to weekly dosing of atovaquoneproguanil, potentially increasing antimalarial prophylaxis uptake, reducing side effects, and lowering costs.
The outcomes will lay the groundwork for future malaria prophylaxis guidelines.
The primary objective of this study is to evaluate the prophylactic efficacy of a weekly oral atovaquoneproguanil regimen in non-immune healthy volunteers using a Controlled Human Malaria Infection (CHMI) model. Secondary objectives include assessing safety, tolerability, and pharmacokinetic
profiles of this regimen. This study will be a single-centre, randomized, placebo-controlled, single-blind clinical trial.
Participants will receive weekly oral atovaquone-proguanil (250/100 mg) and undergo CHMI with PfSPZ Challenge (NF54). The study will evaluate the efficacy of atovaquone-proguanil administered at different intervals relative to malaria exposure, simulating real-world scenarios. Leveraging the expertise and infrastructure of the Institute of Tropical Medicine (ITM) Tübingen, this study builds on a solid foundation of clinical trial capacity and malaria research. This study specifically strives for optimization of antimalarial chemoprophylaxis in travellers and thereby complements the ITM’s clinical trials portfolio on antimalarial prevention by vaccine development targeting populations in endemic regions. This study proposes a significant paradigm shift away from current daily dosing to weekly dosing of atovaquoneproguanil, potentially increasing antimalarial prophylaxis uptake, reducing side effects, and lowering costs.
The outcomes will lay the groundwork for future malaria prophylaxis guidelines.
Involved staff
Managers
Faculty of Medicine
University of Tübingen
University of Tübingen
Contact persons
Faculty of Medicine
University of Tübingen
University of Tübingen
Local organizational units
Department VII, Tropical Medicine
Department of Internal Medicine
Hospitals and clinical institutes, Faculty of Medicine
Hospitals and clinical institutes, Faculty of Medicine
Funders
Braunschweig, Niedersachsen, Germany