Clinical trial NCT02488902: A Randomized, Double-blind, Placebo-controlled Evaluation of Increasing Doses of Weekly Tafenoquine for Chemosuppression of Plasmodium Falciparum
Official title: A Randomized, Double-blind, Placebo-controlled Evaluation of Increasing Doses of Weekly Tafenoquine for Chemosuppression of Plasmodium Falciparum in Semi-immune Adults Living in the Kassena-Nankana District of Northern Ghana
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Malaria
Lead sponsor: U.S. Army Medical Research and Development Command
Sponsor class: FED
Collaborators: name: SmithKline Beecham
First posted: 2015-07-02
Enrollment: 521
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This was a randomised, double-blind, placebo-controlled study to compare the efficacy of a range four weekly doses of tafenoquine, and weekly mefloquine, with placebo as chemosuppression of P. falciparum malaria. Medications and placebo were matched and a double-dummy technique enabled blinding of tafenoquine versus mefloquine.


Eligibility criteria: Inclusion Criteria:

* Willing subjects in good general health.

  * Males aged 18 to 60; females aged 50 to 60.
  * Subjects who planned to stay in the study area until the end of the study.

Exclusion Criteria:

* Subjects with any cardiovascular, liver, neurologic, or renal function abnormality which, in the opinion of the clinical investigators, would have placed them at increased risk of an adverse event or confused the result.

  * Subjects with a personal or family history of seizures or frank psychiatric disorder.
  * Females who had not ceased menstruation; a urine β-human chorionic gonadotrophin (β-HCG) test was to be performed at screening females who had ceased menstruation to exclude pregnancy as a cause.
  * Females who were lactating.
  * Subjects given antimalarial drugs for treatment within two weeks of study drug initiation.
  * Subjects with clinically significant abnormalities (to include but not limited to abnormal hepatic or renal function) as determined by history, physical and routine blood chemistry and haematology values.
  * Subjects with known hypersensitivity to any of the study drugs.
  * Subjects unwilling to remain in the area, report for drug administration or blood drawing during the 3-4 month duration of the study.
  * Subjects with G6PD deficiency (as determined by two separate qualitative tests per subject administered using distinct methods; methods used were visual dye and filter paper methods).
  * Subjects with any of the following laboratory values: haemoglobin (Hb) \<8g/dL, platelets \<80,000/mm3, white blood cell count (WBC) \<3000/mm3, creatinine \>1.5mg/dL, alanine transaminase (ALT) \>60IU or 1+ haematuria as detected by urine dipstick.

Primary outcomes:
measure: First occurrence of malaria infection
timeFrame: 16 weeks
Secondary outcomes:
measure: Time to confirmation of parasitaemia
timeFrame: 16 weeks
Other outcomes:
Locations:
Study officials:
affiliation: US Naval Medical Research Unit
name: Braden Hale, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.