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

Malaria Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02488902
• Other study ID #: A-8340
• Status: Completed
• Phase: Phase 2
• Start date: August 1998
• Est. completion date: March 2003

Study information

• Verified date: September 2018
• Source: U.S. Army Medical Research and Materiel Command
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 521
• Est. completion date: March 2003
• Est. primary completion date: September 1998
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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 ß-human chorionic gonadotrophin (ß-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.

Related Conditions & MeSH terms

• Malaria

Intervention

Drug:
• Placebo
Placebo
• Tafenoquine 25mg
Tafenoquine 25mg
• Tafenoquine 50mg
Tafenoquine 50mg
• Tafenoquine 100 mg
Tafenoquine 100 mg
• Tafenoquine 200 mg
Tafenoquine 200 mg
• Mefloquine 250 mg
Mefloquine 250 mg

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
U.S. Army Medical Research and Materiel Command	SmithKline Beecham

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First occurrence of malaria infection	First occurrence of malaria infection as documented by a positive malaria smear.	16 weeks
Secondary	Time to confirmation of parasitaemia	Time to confirmation of parasitaemia as documented by two consecutive positive smears and the incidence density of parasitaemia.	16 weeks