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Eight Week Primaquine Regimen for the Treatment of Vivax Malaria

This study has been completed.
Sponsor:
Collaborator:
HealthNet TPO
Information provided by:
Gates Malaria Partnership
ClinicalTrials.gov Identifier:
NCT00158587
First received: September 9, 2005
Last updated: July 3, 2007
Last verified: June 2007
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Gates Malaria Partnership:

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

Ages Eligible for Study:   3 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00158587

Sponsors and Collaborators
Gates Malaria Partnership
HealthNet TPO
Investigators
Principal Investigator: Mark Rowland, PhD LSHTM
  More Information

No publications provided by Gates Malaria Partnership

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00158587     History of Changes
Other Study ID Numbers: DIF23
Study First Received: September 9, 2005
Last Updated: July 3, 2007
Health Authority: Pakistan: Ministry of Health
Pakistan: Research Ethics Committee

Keywords provided by Gates Malaria Partnership:
Vivax
Treatment
Primaquine
Asia

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

ClinicalTrials.gov processed this record on November 19, 2014