Testing New Antimalarial Drugs with Induced Malaria Infections
Author Information
Author(s): James S. McCarthy, Silvana Sekuloski, Paul M. Griffin, Suzanne Elliott, Nanette Douglas, Chris Peatey, Rebecca Rockett, Peter O'Rourke, Louis Marquart, Cornelius Hermsen, Stephan Duparc, Jörg Möhrle, Katharine R. Trenholme, Andrew J. Humberstone
Primary Institution: Queensland Institute for Medical Research, University of Queensland, Brisbane, Australia
Hypothesis
Can induced blood-stage Plasmodium falciparum infections in healthy volunteers safely assess the efficacy of new antimalarial drugs?
Conclusion
The study demonstrated that induced blood-stage malaria infections are a safe and effective method for testing new antimalarial drugs.
Supporting Evidence
- All volunteers in the second and third cohorts reached the target parasitemia of ≥1,000 parasites/mL.
- The mean parasite reduction ratio was significantly higher for artemether-lumefantrine compared to atovaquone-proguanil.
- No serious adverse events were recorded during the study.
Takeaway
Researchers gave malaria to healthy volunteers to see if new medicines work safely. They found that one medicine worked much better than another.
Methodology
A Phase IIa trial with 19 healthy male volunteers who were infected with blood-stage malaria and treated with two different antimalarial drugs.
Potential Biases
Potential bias due to the unblinded nature of the trial and the small number of participants.
Limitations
The study had a small sample size and was unblinded, which may affect the generalizability of the results.
Participant Demographics
19 healthy, malaria-naïve male volunteers aged 18 to 45, predominantly Caucasian.
Statistical Information
P-Value
p<0.01
Confidence Interval
95% CI 120–4786 for A/L and 7–40 for A/P
Statistical Significance
p<0.01
Digital Object Identifier (DOI)
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