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Completed

NCT Number: NCT01743820

Phase2a Primaquine Dose Escalation Study

The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of low single-dose primaquine for gametocidal activity against P.falciparum among adult glucose-6-phosphate dehydrogenase (G6PD)-normal malaria patients.

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Key information

Conditions

Malaria Infections Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Malaria Research and Training Centre

Bamako, Mali

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male
  • Age >= 18 years and < 50 years
  • Malaria blood thick film positive
  • Presence of gametocytes on thick blood film
  • Agrees to admission to study ward for 26 hours post diagnosis and available for follow up visits
  • No allergies to study drugs
  • Hemoglobin >= 8 g/dl
  • No evidence of severe or chronic disease
  • Written, informed consent

Treatment and study plan

Dihydroartemisinin-Piperaquine

Drug

0.125 mg/kg Primaquine

Drug

0.5 mg/kg Primaquine

Drug

0.25 mg/kg primaquine

Drug

0.0625 mg/kg Primaquine

Drug

Primary outcomes

  1. mosquito infectivity assessed through membrane feeding

    Time frame: 7 days

    Baseline, Days 1, 2, 7

Secondary outcomes

  1. gametocyte prevalence and density

    Time frame: 28 days

    Baseline, Hours 2, 6, 12, 24, Days 2, 3, 7, 14, 28

  2. primaquine pharmacokinetics - area under the curve (AUC) of parent drug and metabolite

    Time frame: 24 hours

    Hours 1, 2, 3, 4, 6, 8, 12, 24

  3. asexual parasite prevalence and density

    Time frame: 28 days

    Baseline, Hours 2, 6, 12, 24, Days 2, 3, 7, 14, 28

  4. safety measurements including hemoglobin and signs of hemolysis

    Time frame: 28 days

    Baseline, Days 1, 2, 3, 7, 14, 28

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Bill and Melinda Gates Foundation
  • Mahidol Oxford Tropical Medicine Research Unit
  • Malaria Research and Training Center, Bamako, Mali
  • Shoklo Malaria Research Unit
  • Wellcome Trust

Registry information

Official study title

Phase 2a Dose Escalation Study of the Efficacy, Safety, and Pharmacokinetics of Low Dose Primaquine for Gametocytocidal Activity Against P. Falciparum in Sub-Saharan Africa and South East Asia

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 6, 2012
Registry last updated
Jan 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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