Clinical Trial: An Evaluation of Weekly Tafenoquine

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: This was a placebo controlled, randomised, double-blind, double-dummy study of the efficacy of weekly tafenoquine compared with weekly mefloquine or placebo in the chemosuppression of P. falciparum in Nyanza Province, western Kenya.

Detailed Summary: Subjects were treated for 3 days with halofantrine to clear any existing parasitaemia. At the end of the clearance period, subjects free from malaria parasitaemia were randomized and received a loading dose of the study treatment (tafenoquine 200 mg, Mefloquine 250 mg or placebo) for tree days, followed by study treatment (tafenoquine 200 mg, mefloquine 250 mg or placebo, respectively) once a week for 24 weeks. After the treatment period subjects attended weekly follow-up safety visits until week 28.
Sponsor: U.S. Army Medical Research and Materiel Command

Current Primary Outcome: Prophylactic Outcome Defined by the Subject Having no Positive Smears [ Time Frame: 24 Weeks ]

Chemoprophylactic efficacy of weekly tafenoquine compared to placebo. 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.


Original Primary Outcome: Prophylactic outcome defined by the subject having no positive smears. [ Time Frame: 24 Weeks ]

Current Secondary Outcome:

  • 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. 95.5% confidence intervals were constructed for the relative risk.
  • 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.


Original Secondary Outcome:

  • Number of subjects with two consecutive positive smears. [ Time Frame: 24 Weeks ]
  • Number of subjects with a single positive smear during the prophylactic treatment phase plus follow-up. [ Time Frame: 28 Weeks ]
  • Number of subjects with two consecutive positive smears [ Time Frame: 28 Weeks ]
  • Time to a single positive smear. [ Time Frame: 28 Weeks ]
  • Time to two consecutive positive smears [ Time Frame: 28 Weeks ]


Information By: U.S. Army Medical Research and Materiel Command

Dates:
Date Received: June 24, 2015
Date Started: May 2000
Date Completion:
Last Updated: January 5, 2017
Last Verified: January 2017