Phase 2A Dose Escalation Study of the Efficacy, Safety and Pharmacokinetics of Low Single-Dose Primaquine for Gametocytocidal Activity against P. Falciparum in Sub-Saharan Africa

Phase 2A Dose Escalation Study of the Efficacy, Safety and Pharmacokinetics of Low Single-Dose Primaquine for Gametocytocidal Activity against P. Falciparum in Sub-Saharan Africa

Objectives

1. To evaluate the safety, efficacy, and pharmacokinetics of low single-dose primaquine for gametocidal activity against P.falciparum among adult glucose-6-phosphate dehydrogenase (G6PD)-normal malaria patients.
2. To evaluate efficiacy of DP +SLD PQ  vs DP + methylene Blue, VS SPAQ vs SPAQ + SLD PQ to prevetn transmission of  P falciparum.
3. Dose Adaptive trial of SLD-PQ safety in G6PD deficient Malian adults.
4. Age de-escalation study of SLD-PQ dose in G6PD deficient Malian adolescents and children.
5. Qualatatiive assessment to assess the readiness of Asian Pacific countries to roll out routine G6PD testing for the case management of P vivax.
6. Maintain momentum of the SLD PQ Roll Out group to deliver therapeutic range of SLD PQ and support the availblilty of qualitly assured SLD PQ in countrie that want it.

PI Institution(s)

Principal Investigator (PI)

Funding source(s)

Partner(s)

Key facts

  • Dates
    Oct 2013 to Feb 2015
    Country
    • Thailand
    • Mali

MESA tags

  • Methodology
    Operational research, Product development & clinical research
    Theme(s)
    Tools for elimination