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

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ClinicalTrials.gov Identifier: NCT02488902
Recruitment Status : Completed
First Posted : July 2, 2015
Last Update Posted : September 13, 2018
Sponsor:
Collaborator:
SmithKline Beecham
Information provided by (Responsible Party):
U.S. Army Medical Research and Development Command

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.

Condition or disease Intervention/treatment Phase
Malaria Drug: Placebo Drug: Tafenoquine 25mg Drug: Tafenoquine 50mg Drug: Tafenoquine 100 mg Drug: Tafenoquine 200 mg Drug: Mefloquine 250 mg Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 521 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : August 1998
Actual Primary Completion Date : September 1998
Actual Study Completion Date : March 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo was administered initially as a loading course of one capsule daily for 3 days, followed by a weekly dosing regimen at the same dose.
Drug: Placebo
Placebo

Experimental: Tafenoquine 25mg
Tafenoquine was administered initially as a loading course of one capsule daily for 3 days, followed by a weekly dosing regimen at the same dose.
Drug: Tafenoquine 25mg
Tafenoquine 25mg

Experimental: Tafenoquine 50mg
Tafenoquine was administered initially as a loading course of one capsule daily for 3 days, followed by a weekly dosing regimen at the same dose.
Drug: Tafenoquine 50mg
Tafenoquine 50mg

Experimental: Tafenoquine 100 mg
Tafenoquine was administered initially as a loading course of one capsule daily for 3 days, followed by a weekly dosing regimen at the same dose.
Drug: Tafenoquine 100 mg
Tafenoquine 100 mg

Experimental: Tafenoquine 200 mg
Tafenoquine was administered initially as a loading course of one capsule daily for 3 days, followed by a weekly dosing regimen at the same dose.
Drug: Tafenoquine 200 mg
Tafenoquine 200 mg

Experimental: Mefloquine 250 mg
Mefloquine was administered initially as a loading course of one capsule daily for 3 days, followed by a weekly dosing regimen at the same dose.
Drug: Mefloquine 250 mg
Mefloquine 250 mg




Primary Outcome Measures :
  1. First occurrence of malaria infection [ Time Frame: 16 weeks ]
    First occurrence of malaria infection as documented by a positive malaria smear.


Secondary Outcome Measures :
  1. Time to confirmation of parasitaemia [ Time Frame: 16 weeks ]
    Time to confirmation of parasitaemia as documented by two consecutive positive smears and the incidence density of parasitaemia.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

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): NCT02488902


Sponsors and Collaborators
U.S. Army Medical Research and Development Command
SmithKline Beecham
Investigators
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Principal Investigator: Braden Hale, MD US Naval Medical Research Unit
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: U.S. Army Medical Research and Development Command
ClinicalTrials.gov Identifier: NCT02488902    
Other Study ID Numbers: A-8340
First Posted: July 2, 2015    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018
Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases
Infections
Vector Borne Diseases
Mefloquine
Tafenoquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents