Comparison Between 7 & 14 Day Primaquine Combined With

Status Completed

Clinical Trial Summary

In Southeast Asia, Plasmodium vivax (Pv) infection reaches 50-80% and bears a greater burden of disease than Plasmodium falciparum (Pf). As control over Pf improves, Pv will assume increasingly larger percentages of malaria prevalence. The chronicity of Pv, due to the latent liver stage (hypnozoite) not eradicated by chloroquine, causes recurring disability and compounds the economic burden of those with symptomatic disease. The only widely available treatment for hypnozoites is primaquine, which, because of challenges with tolerability, safety in G6PD deficient persons, and compliance, is not commonly prescribed for the treatment of Pv. Currently, chloroquine is used for the treatment of the blood stages of Pv, however, there are concerns about increasing parasite resistance. Alternative treatments, such as artesunate, should be considered in the future of the treatment of blood stage Pv. The use of primaquine in the treatment of hypnozoites (radical cure) should be emphasized so that transmission of Pv can be controlled.

This study aims to determine the optimal primaquine regimen for radical cure of Plasmodium vivax. Chloroquine is currently the standard of treatment for Plasmodium vivax. Chloroquine may have synergistic effects when used with primaquine and due to its long half-life may delay the first relapse of vivax malaria. In contrast, artesunate does not have documented interactions with primaquine and has a very short half-life, thus, presumably will have no impact on first relapse. Combining primaquine with these two anti-malarials may lead to an alternative regimen for Pv infection and changing the primaquine dosing regimen may lead to a more practical and efficacious therapy.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01640574
Study type	Interventional
Source	University of Oxford
Contact
Status	Completed
Phase	Phase 3
Start date	February 2012
Completion date	December 2015

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See also
Status	Clinical Trial	Phase
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Completed	`NCT00157833` - A Randomized Trial of Coartemether and Artekin for the Treatment of Uncomplicated Malaria in Papua, Indonesia.	N/A
Active, not recruiting	`NCT03529396` - Safety and Efficacy of Different Regimens of Primaquine on Vivax Malaria Treatment in G6PD Deficient Patients	Phase 2
Recruiting	`NCT05874271` - Short Course Primaquine for the Radical Cure of P. Vivax - Papua New Guinea	N/A
Completed	`NCT05958797` - TES of Chloroquine for Pv in the Philippines in 2016
Completed	`NCT01716260` - Safety and Efficacy of Chloroquine and Primaquine for Vivax Malaria in Bhutan	N/A
Completed	`NCT01288820` - Study of ACTs Plus Primaquine for Uncomplicated Plasmodium Vivax Malaria	Phase 3
Completed	`NCT01076868` - Incidence of Vivax Along the Thai Burma Border	N/A
Completed	`NCT00158561` - Chlorproguanil/Dapsone Compared With Chloroquine and SP for Vivax Malaria	Phase 3
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Completed	`NCT06044805` - Therapeutic Efficacy of Chloroquine Plus Primaquine in the Treatment of Uncomplicated Plasmodium Vivax	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Comparison Between 7 and 14 Day Primaquine Combined With Dihydroartemisinin-piperaquine or 3 Day Chloroquine Radical Cure of P. Vivax (BPD)

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms