Eight Week Primaquine Regimen for the Treatment of Vivax Malaria
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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. |
- 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 ]
| 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 |
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
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 Protozoan Infections Parasitic Diseases Primaquine Antimalarials |
Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013