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Evaluation of Weekly Tafenoquine

Primary Purpose

Malaria

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Tafenoquine
Placebo
Sponsored by
U.S. Army Medical Research and Development Command
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malaria

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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.
  2. Female subjects who were pregnant (Positive serum / plasma -HCG as tested within 48 hours of first drug administration).
  3. Use of antimalarial drugs not prescribed by study physicians within 2 weeks of study drug initiation.
  4. 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.
  5. Known hypersensitivity to any study drug.
  6. Unwilling to remain in area and report for drug administration and blood drawing during the duration of the study.
  7. Glucose 6 Phosphate Dehydrogenase (G6PD) deficiency.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Load only

    Low weekly dose

    High weekly dose

    Placebo

    Arm Description

    Loading with tafenoquine 400 mg base for three days followed by placebo weekly.

    Loading with tafenoquine 200 mg base for 3 days followed by tafenoquine 200 mg weekly.

    Loading with tafenoquine to 400 mg base for 3 days followed by tafenoquine 400 mg base weekly.

    Loading with placebo for 3 days followed by placebo once weekly.

    Outcomes

    Primary Outcome Measures

    Prophylactic outcome.
    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 Outcome Measures

    Prophylactic outcome after 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.
    Prophylactic outcome after 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.

    Full Information

    First Posted
    June 30, 2015
    Last Updated
    September 12, 2018
    Sponsor
    U.S. Army Medical Research and Development Command
    Collaborators
    SmithKline Beecham
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02491606
    Brief Title
    Evaluation of Weekly Tafenoquine
    Official Title
    Evaluation of Weekly Tafenoquine (SB 252263 / WR 238605) Compared to Placebo for Chemosuppression of Plasmodium Falciparum in Western Kenya
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    May 1997 (undefined)
    Primary Completion Date
    September 1997 (Actual)
    Study Completion Date
    September 1998 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    U.S. Army Medical Research and Development Command
    Collaborators
    SmithKline Beecham

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Malaria

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    249 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Load only
    Arm Type
    Experimental
    Arm Description
    Loading with tafenoquine 400 mg base for three days followed by placebo weekly.
    Arm Title
    Low weekly dose
    Arm Type
    Experimental
    Arm Description
    Loading with tafenoquine 200 mg base for 3 days followed by tafenoquine 200 mg weekly.
    Arm Title
    High weekly dose
    Arm Type
    Experimental
    Arm Description
    Loading with tafenoquine to 400 mg base for 3 days followed by tafenoquine 400 mg base weekly.
    Arm Title
    Placebo
    Arm Type
    Experimental
    Arm Description
    Loading with placebo for 3 days followed by placebo once weekly.
    Intervention Type
    Drug
    Intervention Name(s)
    Tafenoquine
    Intervention Description
    Tafenoquine 200mg and 400 mg
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo
    Primary Outcome Measure Information:
    Title
    Prophylactic outcome.
    Description
    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.
    Time Frame
    13 Weeks
    Secondary Outcome Measure Information:
    Title
    Prophylactic outcome after 7 weeks
    Description
    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.
    Time Frame
    7 Weeks
    Title
    Prophylactic outcome after 10 weeks
    Description
    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.
    Time Frame
    10 Weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    A.J Oloo
    Organizational Affiliation
    Kenya Medical Research Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    28495354
    Citation
    Novitt-Moreno A, Ransom J, Dow G, Smith B, Read LT, Toovey S. Tafenoquine for malaria prophylaxis in adults: An integrated safety analysis. Travel Med Infect Dis. 2017 May-Jun;17:19-27. doi: 10.1016/j.tmaid.2017.05.008. Epub 2017 May 8.
    Results Reference
    derived

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    Evaluation of Weekly Tafenoquine

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