Healthy Clinical Trial
Official title:
A Pilot Phase II Study of the Efficacy of Antimalarial Drugs Against Plasmodium Falciparum by Experimental Challenge With a Low Dose of Blood Stage Parasites in Healthy Male Volunteers
This is a pilot study of a protocol for inducing a falciparum malaria infection in healthy volunteers in order to test the activity of novel agents being developed as drugs for the treatment of uncomplicated malaria. In this pilot study, 16 healthy male volunteers will be administered a low level malaria infection via infected human red blood cells. After 6 days they will be administered one of two registered antimalarial treatments (8 volunteers for each treatment) in order to define the rate of clearance of the infection. This information will be used to design similar future studies for the initial assessment of the efficacy of novel antimalarial drugs in development.
This is a single-center, controlled, randomized, study using a BSP inoculum challenge as a
model to assess the activity of antimalarial agents. The study will be conducted in 2
cohorts (n = 6 and n = 10). Cohort 2 will not commence until at least after day 12 of cohort
1 and review by Safety Review Team following day 9 exit of cohort 1. The participants will
be randomized 1:1 to the two registered antimalarials. This is an enabling study using
registered antimalarial drugs as reference treatments (one slow acting and one fast acting),
aimed to inform trial design, endpoints and testing regimens for assessing new candidate
antimalarial drugs in development. The study will follow the sequence of the challenge
inoculation, reference treatment and follow-up.
Healthy male participants will be inoculated on Day 1 with ~1,800 Plasmodium
falciparum-infected human erythrocytes administered intravenously. On an outpatient basis,
participants will be monitored morning (AM) and night (PM) from day 3 to day 5 for adverse
events and the unexpected early onset of symptoms, signs or parasitological evidence of
malaria. On day 5 evening, participants will be admitted to the study unit and confined for
safety monitoring and antimalarial treatment. Reference treatment administration will begin
on the evening of Day 6 and continued on Day 7 and 8 (3 days of treatment).
If clinical or parasitologic evidence of malaria (either the identification of two or more
malaria parasites on a malaria thick film, platelet count less than 100 x109/L, or the onset
of clinical features of malaria) occurs before day 6 evening, allocated treatment will begin
at this time.
Following treatment, participants will be followed up as inpatients for at least 86 hours,
(4 evenings) to ensure tolerance of the therapy and clinical response, then if clinically
well on an outpatient basis for safety and continued presence of malaria parasites via PCR
and thick blood film review.
Adverse events will be monitored via telephone monitoring, within the clinical research unit
and on outpatient review after malaria challenge inoculation and antimalarial study drug
administration. Blood samples for safety evaluation, malaria monitoring, and red blood cell
antibodies will be drawn at baseline and at nominated times after malaria challenge.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
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