NCT02491606 - Evaluation of Weekly Tafenoquine | Crick

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

249

Conditions

Malaria

Interventions

TafenoquineDRUG

Tafenoquine 200mg and 400 mg

PlaceboOTHER

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 13 Weeks

Secondary Outcomes

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.

Time frame: 7 Weeks

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.

Time frame: 10 Weeks