Trial | NCT03916003  Report issue

Title

Reducing the Risk of P. Vivax After Falciparum Infections in Co-endemic Areas
Reducing the Risk of P. Vivax After Falciparum Infections in Co-endemic Areas - a Randomized Controlled Trial

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    500
This study is designed as a multi-centre randomized, open label trial to compare the safety and efficacy of a high dose primaquine (PQ) treatment in G6PD normal patients with P. falciparum to reduce the risk of subsequent P. vivax episodes to current standard practice of providing only schizontocidal treatment.
Plasmodium vivax forms dormant liver stages that reactivate weeks or months following an acute infection. Recurrent infections can be associated with a febrile illness, a cumulative risk of severe anaemia, direct and indirect mortality, and are the most important source of onward transmission of the parasite. In co-endemic areas, there is a very high risk (up to 50%) of patients representing with P. vivax malaria following treatment of P. falciparum. Hence, in co-endemic regions there is a strong rationale for eradicating P. vivax hypnozoites from the liver in patients presenting with uncomplicated P. falciparum infections.

The recently completed multicentre IMPROV study compared the efficacy of a 7 day primaquine regimen (1.0 mg/kg/day for 7 days) with a 14 day regimen (0.5 mg/kg/day for 14 days). The 7 day PQ regimen was non-inferior to the 14 day regimen and 5-fold more efficacious at reducing P. vivax recurrence than the control.

This study is designed as a multicentre randomized, open label trial to compare the safety and efficacy of a high dose PQ treatment in G6PD normal patients with P. falciparum to reduce the risk of subsequent P. vivax episodes to current standard practice of providing only schizontocidal treatment.
Study Started
Aug 18
2019
Primary Completion
May 14
2022
Study Completion
Jul 30
2022
Last Update
Nov 21
2023

Drug primaquine

Primaquine regimen over 7 days (1.0 mg/kg/day for 7 days)

PQ7 Experimental

high dose primaquine regimen over 7 days (1.0 mg/kg/day for 7 days)

standard care No Intervention

As per national guidelines for P. falciparum treatment

Criteria 

Inclusion Criteria:

P. falciparum mono-infection
Fever (axillary temperature ≥37.5⁰C) or history of fever in preceding 48 hours
Age >1 years (≥ 18 years at the Ethiopia site)
G6PD normal as defined by the Biosensor (SD Biosensor, ROK) at ≥70% of the adjusted male median (AMM) for each site
Written informed consent
Able to comply with all study procedures and timelines

Exclusion Criteria:

General danger signs or symptoms of severe malaria
Anaemia, defined as Hb <8g/dl
Pregnant women as determined by Urine β-HCG pregnancy test
Breast feeding women
Known hypersensitivity to any of the drugs given
Regular use of drugs with haemolytic potential
Blood transfusion within the last 4 months
No Results Posted