A Randomized, Double-blind, Placebo-controlled Evaluation of Increasing Doses of Weekly Tafenoquine for Chemosuppression of Plasmodium Falciparum

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02488902

Enrollment

521

Registered

2015-07-02

Start date

1998-08-31

Completion date

2003-03-31

Last updated

2018-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria

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.

Interventions

DRUGPlacebo

Placebo

DRUGTafenoquine 25mg

Tafenoquine 25mg

DRUGTafenoquine 50mg

Tafenoquine 50mg

DRUGTafenoquine 100 mg

Tafenoquine 100 mg

DRUGTafenoquine 200 mg

Tafenoquine 200 mg

DRUGMefloquine 250 mg

Mefloquine 250 mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
First occurrence of malaria infection	16 weeks	First occurrence of malaria infection as documented by a positive malaria smear.

Secondary

Measure	Time frame	Description
Time to confirmation of parasitaemia	16 weeks	Time to confirmation of parasitaemia as documented by two consecutive positive smears and the incidence density of parasitaemia.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026