Evaluation of Weekly Tafenoquine
Primary Purpose
Malaria
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Tafenoquine
Placebo
Sponsored by

About this trial
This is an interventional treatment trial for Malaria
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.
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
NCT ID
NCT02491606
First Posted
June 30, 2015
Last Updated
September 12, 2018
Sponsor
U.S. Army Medical Research and Development Command
Collaborators
SmithKline Beecham
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
Learn more about this trial
Evaluation of Weekly Tafenoquine
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