Eight Week Primaquine Regimen for the Treatment of Vivax Malaria

NCT00158587 | Completed Phase 3 DMC

• 1 other identifier: DIF23
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Malaria; Vivax Malaria

Keywords

Vivax; Treatment; Primaquine; Asia

Outcome Measures

Primary Outcomes (1)

• Primary Efficacy Variable: Proportion with relapse(s) of P. vivax in 12 months of follow-up.

  2004-March 2007

Secondary Outcomes (3)

• Secondary Efficacy Variables: Time to subsequent relapse episode

  2004-March 2007

• Number of relapse episodes in 12 months

  2004-March 2007

• Side effects / adverse events

  2004-March 2007

Interventions

primaquine DRUG

Eligibility Criteria

• Age: 3 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• HealthNet TPO: collaborator

Related Publications (1)

• Leslie T, Mayan I, Mohammed N, Erasmus P, Kolaczinski J, Whitty CJ, Rowland M. A randomised trial of an eight-week, once weekly primaquine regimen to prevent relapse of plasmodium vivax in Northwest Frontier Province, Pakistan. PLoS One. 2008 Aug 6;3(8):e2861. doi: 10.1371/journal.pone.0002861.

  PMID: 18682739 DERIVED

MeSH Terms

Conditions

Malaria; Malaria, Vivax

Interventions

Primaquine

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Mark Rowland, PhD

  London School of Hygiene and Tropical Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 12, 2005
• Study Start: April 1, 2004
• Study Completion: March 1, 2007
• Last Updated: January 12, 2017

Record last verified: 2017-01