An Evaluation of Weekly Tafenoquine
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|ClinicalTrials.gov Identifier: NCT02488980|
Recruitment Status : Completed
First Posted : July 2, 2015
Results First Posted : February 24, 2017
Last Update Posted : May 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|Falciparum Parasitaemia||Drug: Tafenoquine Drug: Mefloquine Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||306 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Randomized, Double Blind, Placebo Controlled Evaluation of Weekly Tafenoquine (WR 238605/SB252263) Compared to Mefloquine for Chemosuppression of Plasmodium Falciparum in Western Kenya|
|Study Start Date :||May 2000|
|Actual Primary Completion Date :||October 2000|
|Actual Study Completion Date :||March 2003|
Tafenoquine 200 mg for three days followed by Tafenoquine 200 once a week for 24 weeks.
Tafenoquine 200 mg for three days followed by Tafenoquine 200 mg once a week for 24 weeks.
Active Comparator: Mefloquine
Mefloquine 250 mg for three days followed by Mefloquine 250 once a week for 24 weeks.
Mefloquine 250 mg for three days followed by Mefloquine 250 mg once a week for 24 weeks.
Placebo Comparator: Placebo
Placebo for three days followed by placebo once a week for 24 weeks
- Prophylactic Outcome Defined by the Subject Having no Positive Smears [ Time Frame: 24 Weeks ]Prophylactic outcome (success/failure) at the end of the prophylactic treatment phase; outcome was based on absence/presence of asexual stage parasites of any Plasmodium species on a single blood smear.
- Protective Efficacy Based on Two Consecutive Positive Smears [ Time Frame: 24 Weeks ]Kaplan-Meier survival curves were produced for time to parasitaemia for both first positive smear and two consecutive positive smears. Analysis was based on a calculation of protective efficacy (PE) of tefaenoquine, defined as (1-relative risk of developing parasitaemia tafenoquine: placebo) x100% and 95.5% confidence intervals were constructed for the relative risk using Koopman's method.
- Time to a Single Positive Smear [ Time Frame: 24 Weeks ]Kaplan-Meier survival curves were produced for time to parasitaemia for both first positive smear and two consecutive positive smears. 95.5% confidence intervals were constructed for the relative risk.
- Safety (SAEs and AEs) [ Time Frame: 28 weeks ]The most commonly reported experiences in subject occurring in at least 20% of subjects in any treatment group.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02488980
|Principal Investigator:||Jose Stoute, MD||Penn State Hershey Infectious Diseases|