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
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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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
- Primary Efficacy Variable: Proportion with relapse(s) of P. vivax in 12 months of follow-up. [ Time Frame: 2004-March 2007 ]
- 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 ]
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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|
- 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.
- 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.
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
|Principal Investigator:||Mark Rowland, PhD||LSHTM|
|Responsible Party:||Brian Greenwood, Professor, London School of Hygiene and Tropical Medicine|
|Other Study ID Numbers:||
|First Posted:||September 12, 2005 Key Record Dates|
|Last Update Posted:||January 12, 2017|
|Last Verified:||January 2017|
Vector Borne Diseases