Evaluation of Weekly Tafenoquine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

249

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Load only
Loading with tafenoquine 400 mg base for three days followed by placebo weekly.
Tafenoquine 200mg and 400 mg
Experimental: Low weekly dose
Loading with tafenoquine 200 mg base for 3 days followed by tafenoquine 200 mg weekly.
Tafenoquine 200mg and 400 mg
Experimental: High weekly dose
Loading with tafenoquine to 400 mg base for 3 days followed by tafenoquine 400 mg base weekly.
Tafenoquine 200mg and 400 mg
Experimental: Placebo
Loading with placebo for 3 days followed by placebo once weekly.
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

13 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

7 Weeks
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.

10 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: A.J Oloo, Kenya Medical Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 1997

Primary Completion (Actual)

September 1, 1997

Study Completion (Actual)

September 1, 1998

Study Registration Dates

First Submitted

June 30, 2015

First Submitted That Met QC Criteria

July 2, 2015

First Posted (Estimate)

July 8, 2015

Study Record Updates

Last Update Posted (Actual)

September 13, 2018

Last Update Submitted That Met QC Criteria

September 12, 2018

Last Verified

September 1, 2018

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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