Malaria Clinical Trial
Official title:
Evaluation of Fosmidomycin and Azithromycin When Administered Concurrently to Adult Subjects With Acute Uncomplicated Plasmodium Falciparum Malaria
The aim of this study is to evaluate the role of azithromycin as a possible combination partner for fosmidomycin to protect it from its susceptibility to recrudescent infections when used as monotherapy for acute Plasmodium falciparum malaria while retaining its excellent safety profile.
The scientific rationale for the use of this combination is to inhibit the ability of the
parasite to synthesise isoprenoids, as precursors of many essential compounds including
sterols, carotenoids and ubiquinones. This is effected through blockade of the
non-mevalonate pathway by fosmidomycin as a potent inhibitor of 1-deoxy-D-xylulose
5-phosphate reductoisomerase coupled with targeting of protein biosynthesis by azithromycin
through binding to the 50S ribosomal subunit. This mode of action contrasts with the ability
of the human host to utilise the mevalonate pathway for isoprenoid synthesis and accounts
for the safety profiles of both drugs through the mechanism of selective toxicity. Moreover
it affords protection against cross resistance with existing chemotherapeutic agents.
The dose of fosmidomycin, equivalent to 30mg/kg twice daily for three days, selected for
evaluation in this proof of concept study is derived from the highest dose that was
administered in the Phase I safety tolerance studies. While the recommended dose of
azithromycin for the treatment of bacterial infections is 250mg daily for three days, higher
doses of up to 1500mg daily for three days have been evaluated for the treatment of malaria,
in combination with artesunate or quinine.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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