Last Updated

19 Oct 2018

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

The purpose of this study is 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.

Specific objectives:

  1. To evaluate the efficacy of DP +SLD PQ  vs DP + methylene Blue, VS SPAQ vs SPAQ + SLD PQ to prevent transmission of  P. falciparum.
  2. Dose Adaptive trial of SLD-PQ safety in G6PD deficient Malian adults.
  3. Age de-escalation study of SLD-PQ dose in G6PD deficient Malian adolescents and children.
  4. Qualitative assessment to assess the readiness of Asian Pacific countries to roll out routine G6PD testing for the case management of P. vivax.
  5. Maintain momentum of the SLD PQ Roll Out group to deliver a therapeutic range of SLD PQ and support the availability of quality-assured SLD PQ in countries that want it.
Principal Investigator
Rationale and Abstract

Outcome measures:

  • Primary: mosquito infectivity assessed through membrane feeding 
  • Secondary: gametocyte prevalence and density, primaquine pharmacokinetics - area under the curve (AUC) of parent drug and metabolite, asexual parasite prevalence and density, safety measurements including haemoglobin and signs of hemolysis

NCT id: NCT02011555

Study Design

Phase II, interventional clinical trial 

Thematic Categories

Date

2013 Sep - 2015 Feb
Project Site