Case Study: Evaluating the Safety and Tolerability of Anti-malaria Treatment

SGS Conducts First Non-Academic Blood-Stage Malaria Volunteer Infection Study in Europe.

SGS evaluated the safety and tolerability of anti-malaria treatment after blood-stage malaria infections and characterizing stages in the blood-stage parasite growth profile.

The pioneering Phase Ib proof-of-concept study took place at SGS’s Clinical Pharmacology Unit (CPU), analyzing 16 healthy, malaria-naïve subjects aged between 18 and 55.

Volunteers were infected using the PfSPZ-DVI Challenge model before being confined to the CPU for 10 days and given anti-malarial therapy for three days. The dose depended upon the defined amount of parasites/mL blood. Volunteers were subsequently discharged from the CPU upon parasite clearance and at least 72 hours after having initiated therapy. Approximately 10 days later, they returned for an outpatient follow-up check-in.

Complete the form below to access our latest clinical trial management case studies.

First name *

Last name *

Company name *

Email address *

Location *

I would like to receive relevant communications from SGS.

I agree that SGS can use my data for the purposes of dealing with my request, in accordance with the SGS Online Privacy Statement. *

Key Challenge: Recruitment and Authority Approval

Recruitment and authority approval was challenging due to the study’s pioneering nature. Not only was this study the first blood-stage malaria volunteer infection study in Belgium, it was also the first of its kind on a non-academic site in Europe.

Solution and Outcome: Successful Study Execution

SGS implemented a broad recruitment and advertisement campaign, including social media advertisements, and letters to suitable candidates within SGS’s volunteer database. SGS also contracted an independent malaria expert to oversee the study from start to finish.