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Last Updated: 24/10/2015
The tolerability and safety of low dose primaquine for transmission blocking in symptomatic falciparum infected Cambodians
Objectives
The overall aim of this project is to assess the safety and tolerability of the WHO recommended addition of low dose (0.25mg/kg) primaquine, as a measure to help reduce the transmission of artemisinin-resistant P. falciparum parasites, in Cambodian patients with uncomplicated P. falciparum who are glucose-6-phosphate dehydrogenase deficient (G6PDd).
The primary outcome measured is the day 7 haemoglobin concentration between G6PD-deficient and G6PD normal patients who are treated with dihydroartemisinin-piperaquine alone or combined with low dose primaquine.
In Cambodia, falciparum malaria is becoming more difficult to treat because drugs are becoming less effective. The investigators can help to try to prevent the spread of this resistant malaria by adding a drug (primaquine) that will make it more difficult for the mosquito to acquire the parasite from people’s blood.
Primaquine commonly causes the red cells in the blood to break apart if they are weak. Red cells need enzymes to work properly and weak red cells have low amounts of an enzyme called glucose 6 phosphate dehydrogenase (G6PD). The investigators want to know if treating malaria with primaquine will be safe for the red cells. To do this study, the investigators need to know if a subject has low G6PD or not.
ClinicalTrials.gov Identifier: NCT02434952
| Study Type : | Interventional (Clinical Trial) |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
Oct 2014 — Sep 2016
$150,000
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