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Eight Week Primaquine Regimen for the Treatment of Vivax Malaria

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ClinicalTrials.gov Identifier: NCT00158587
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : January 12, 2017
HealthNet TPO
Information provided by (Responsible Party):
Brian Greenwood, London School of Hygiene and Tropical Medicine

Brief Summary:

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 or disease Intervention/treatment Phase
Malaria Vivax Malaria Drug: primaquine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
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.
Study Start Date : April 2004
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

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

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

Information from the National Library of Medicine

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

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.

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
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Principal Investigator: Mark Rowland, PhD LSHTM
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Brian Greenwood, Professor, London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT00158587    
Other Study ID Numbers: DIF23
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: January 2017
Keywords provided by Brian Greenwood, London School of Hygiene and Tropical Medicine:
Additional relevant MeSH terms:
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Malaria, Vivax
Protozoan Infections
Parasitic Diseases
Vector Borne Diseases
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents