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Completed

NCT Number: NCT02491606

Evaluation of Weekly Tafenoquine

This study is a phase 2b, placebo controlled, randomized, blinded study of the efficacy of WR 238605, a new primaquine analog, compared to placebo as chemosuppression of P. falciparum malaria in Nyanza Province, western Kenya.

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Key information

Conditions

Malaria Infections Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Healthy subjects (male or female)
  • Age of 18-55 years
  • Residing in one of the study villages of the Nyanza Province for the entire study

Exclusion criteria

  • Any cardiovascular, liver, neurologic, or renal functional abnormality which in the opinion of the clinical investigators would place the subject at increased risk of an adverse event or confuse the result.
  • Female subjects who were pregnant (Positive serum / plasma -HCG as tested within 48 hours of first drug administration).
  • Use of antimalarial drugs not prescribed by study physicians within 2 weeks of study drug initiation.
  • Clinically significant abnormalities (including but not limited to abnormal hepatic or renal function) as determined by history, physical and routine blood chemistries and complete blood count.
  • Known hypersensitivity to any study drug.
  • Unwilling to remain in area and report for drug administration and blood drawing during the duration of the study.
  • Glucose 6 Phosphate Dehydrogenase (G6PD) deficiency.

Treatment and study plan

Tafenoquine

Drug

Tafenoquine 200mg and 400 mg

Placebo

Other

Placebo

Primary outcomes

  1. Prophylactic outcome.

    Time frame: 13 Weeks

    Thick blood films were stained with Giemsa stain and malaria parasite counts determined by counting the number of asexual parasites per 200 white blood cells.

    A blood slide was not considered negative until an examination of 200 oil immersion fields showed no parasites.

Secondary outcomes

  1. Prophylactic outcome after 7 weeks

    Time frame: 7 Weeks

    Thick blood films were stained with Giemsa stain and malaria parasite counts determined by counting the number of asexual parasites per 200 white blood cells.

    A blood slide was not considered negative until an examination of 200 oil immersion fields showed no parasites.

  2. Prophylactic outcome after 10 weeks

    Time frame: 10 Weeks

    Thick blood films were stained with Giemsa stain and malaria parasite counts determined by counting the number of asexual parasites per 200 white blood cells.

    A blood slide was not considered negative until an examination of 200 oil immersion fields showed no parasites.

Sponsors and collaborators

Lead sponsor

U.S. Army Medical Research and Development Command

Fed

Collaborators

  • SmithKline Beecham

Registry information

Official study title

Evaluation of Weekly Tafenoquine (SB 252263 / WR 238605) Compared to Placebo for Chemosuppression of Plasmodium Falciparum in Western Kenya

Important dates

Study start
1997
Primary completion
1997
Study completion
1998
First posted
Jul 8, 2015
Registry last updated
Sep 13, 2018

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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