A Phase 2 interventional study of Fosmidomycin in Malaria, sponsored by Jomaa Pharma GmbH. Withdrawn at 1 site in Thailand. Open to participants aged 15 Years to 55 Years. Per ClinicalTrials.gov, last updated 2011-09-27.
Sponsored by Jomaa Pharma GmbH · Phase 2, Interventional, and Treatment
The aim of this study is to evaluate the role of clindamycin and artesunate as possible combination partners 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.
1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.
This study's planned enrollment of 40 is below the median of 220 across 1,027 interventional studies indexed under Malaria.
Browse Malaria studies →Jomaa Pharma GmbH is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Fos-clin/Arte
Drug: Fosmidomycin
450 mg capsules, every 12 hrs for 3 days
Efficacy of fosmidomycin and clindamycin/artesunate when co-administered to adults with acute uncomplicated P.f. malaria.
Time frame: 12 months
To determine the viability and infectivity of gametocytes induced by the co-administration of fosmidomycin with clindamycin or with clindamycin plus artesunate to adult subjects with acute uncomplicated Plasmodium falciparum malaria.
Time frame: 12 months
This study is withdrawn, as verified in Aug 2010. You cannot join it, but the record below documents what was studied.
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Jomaa Pharma GmbH