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Completed

NCT Number: NCT04411836

Effectiveness of Novel Approaches to Radical Cure With Tafenoquine and Primaquine

Health care facility based, randomized, controlled, open label, superiority trial with 3 arms

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Key information

Conditions

Vivax Malaria Infections Malaria Malaria Relapse Malaria, Vivax Mosquito-Borne Diseases Parasitic Diseases Plasmodium Vivax Protozoan Infections Vector Borne Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kravanh District Hospital, Pursat, Cambodia

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About this study

  • To assess the effectiveness of a short-course of high dose primaquine (total dose 7mg/kg given unsupervised over 7 days) compared to the current standard low dose primaquine regimen (total dose 3.5mg/kg given unsupervised over 14 days).
  • To assess the effectiveness of tafenoquine (single dose of 300mg) compared to the short-course high dose primaquine regimen.
  • To assess the safety of tafenoquine compared to the high and low dose primaquine regimens.
  • To assess the cost-effectiveness and feasibility of high dose primaquine and tafenoquine compared to the current low dose primaquine regimen

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • P. vivax peripheral parasitaemia (mono-infection) as determined by microscopy
  • G6PD normal status (G6PD activity ≥ 70% of the adjusted male median as determined by the Biosensor™ (SD Biosensor, ROK))
  • Fever (temperature ≥37.5⁰C) or history of fever in the preceding 48 hours
  • Age ≥18 years
  • Written informed consent
  • Living in the study area and willing to be followed for six months

Exclusion criteria

  • Danger signs or symptoms of severe malaria
  • Anaemia (defined as Hb <8g/dl)
  • Pregnant or lactating females
  • Known hypersensitivity to any of the study drugs
  • Regular use of drugs with haemolytic potential

Treatment and study plan

Tafenoquine

Drug

patients are treated with schizontocidal treatment plus a single dose of Tafenoquine (TQ).

Primaquine

Drug

patients are treated with schizontocidal treatment plus high dose PQ (total dose 7 mg/kg) unsupervised over 7 days (PQ7)

Other names: Primaquine 7 days

Primary outcomes

  1. Incidence risk any P vivax PQ7 / PQ14

    Time frame: 6 months

    The incidence risk (time to first event) of any P. vivax parasitaemia during the 6-month follow up period as determined by microscopy compared between the PQ7 arm and the control arm (PQ14).

Secondary outcomes

  1. Incidence risk any P vivax PQ7 / TQ

    Time frame: 6 months

    The incidence risk (time to first event) of any P. vivax parasitaemia during the 6 months follow up period as determined by microscopy compared between PQ7 and TQ arms

  2. Incidence risk symptomatic P vivax TQ / PQ14

    Time frame: 6 months

    The incidence risk (time to first event) of symptomatic P. vivax parasitaemia during the 6 months follow up period as determined by microscopy compared between TQ and the control arm (PQ14).

  3. Incidence risk any P vivax PQ7 / PQ14

    Time frame: 6 months

    The incidence risk (time to first event) of symptomatic P. vivax parasitaemia during the 6-month follow up period as determined by microscopy compared between the PQ7 arm and the control arm (PQ14).

  4. Incidence risk any P vivax PQ7 / TQ

    Time frame: 6 months

    • The incidence risk (time to first event) of any P. vivax parasitaemia during the 6 months follow up period as determined by microscopy compared between PQ7 and TQ arms

  5. Incidence risk any P vivax PQ14 / TQ

    Time frame: 6 months

    The incidence risk (time to first event) of any P. vivax parasitaemia during the 6 months follow up period as determined by microscopy compared between PQ14 and TQ arms

Sponsors and collaborators

Lead sponsor

Menzies School of Health Research

Other

Collaborators

  • Aga Khan University
  • Arba Minch University
  • Ethiopian Public Health Institute
  • Mahidol Oxford Tropical Medicine Research Unit
  • National Centre for Parasitology, Entomology and Malaria Control, Cambodia
  • Universitas Sumatera Utara
  • University of Melbourne

Registry information

Official study title

Effectiveness of Novel Approaches to Radical Cure With Tafenoquine and Primaquine - a Randomized Controlled Trial in P. Vivax Patients

Acronym: EFFORT

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jun 2, 2020
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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