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Eight Week Primaquine Regimen for the Treatment of Vivax Malaria

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00158587
First Posted: September 12, 2005
Last Update Posted: January 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
HealthNet TPO
Information provided by (Responsible Party):
Brian Greenwood, London School of Hygiene and Tropical Medicine
  Purpose

Plasmodium vivax represents a major health problem throughout the tropics. Outside Africa it accounts for over 50% of cases, affecting an estimated 70-80 million people per year. A substantial proportion of clinical cases are not caused by infective bites of Anopheles spp, but by activation of latent hypnozoites in the liver. These relapses may significantly impede development since each illness may result in 5-15 days of absence from work or school.

Primaquine(PQ) is the only drug available that eliminates hypnozoites, though its use is beset by clinical problems; it may precipitate haemolytic anaemia in individuals deficient in the blood enzyme glucose 6 phosphate dehydrogenase (G6PD). Without affordable G6PD testing, primaquine use is precluded. Evidence suggests, however, that a course of 8 weekly doses may be a safe and effective alternative to the traditional 14 day course of the drug. The aim of the proposed study, therefore, is to test whether 8 weekly doses of primaquine is as effective as the 14 day course at preventing relapse malaria, without the risk of hemolysis in G6PD deficient individuals.


Condition Intervention Phase
Malaria Vivax Malaria Drug: primaquine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Placebo Controlled, Randomised Evaluation of an Eight Week Primaquine Regimen for the Treatment of Vivax Malaria.

Resource links provided by NLM:


Further study details as provided by Brian Greenwood, London School of Hygiene and Tropical Medicine:

Primary Outcome Measures:
  • Primary Efficacy Variable: Proportion with relapse(s) of P. vivax in 12 months of follow-up. [ Time Frame: 2004-March 2007 ]

Secondary Outcome Measures:
  • Secondary Efficacy Variables: Time to subsequent relapse episode [ Time Frame: 2004-March 2007 ]
  • Number of relapse episodes in 12 months [ Time Frame: 2004-March 2007 ]
  • Side effects / adverse events [ Time Frame: 2004-March 2007 ]

Enrollment: 150
Study Start Date: April 2004
Study Completion Date: March 2007
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients diagnosed with P. vivax parasitaemia
  • Patients over 3 years
  • Patients with G6PD deficiency to a safety trial
  • Patients without G6PD deficiency to all other groups.

Exclusion Criteria:

  • Children under the age of three
  • Pregnant / breast feeding women
  • Patients with severe clinical anaemia [Hb<7g/dl]
  • Patients with P. falciparum
  • Patients unavailable for the duration of study.
  • Patients who have taken antimalarial drugs in the 2 weeks prior to consultation.
  • Patients with concomitant infections or whose general health is considered too poor.
  Contacts and Locations
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): NCT00158587


Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
HealthNet TPO
Investigators
Principal Investigator: Mark Rowland, PhD LSHTM
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Brian Greenwood, Professor, London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT00158587     History of Changes
Other Study ID Numbers: DIF23
First Submitted: September 9, 2005
First Posted: September 12, 2005
Last Update Posted: January 12, 2017
Last Verified: January 2017

Keywords provided by Brian Greenwood, London School of Hygiene and Tropical Medicine:
Vivax
Treatment
Primaquine
Asia

Additional relevant MeSH terms:
Malaria
Malaria, Vivax
Protozoan Infections
Parasitic Diseases
Primaquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents