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Artesunate Plus Sulfadoxine-Pyrimethamine Versus Chloroquine for Vivax Malaria

Primary Purpose

Malaria, Vivax

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Sulfadoxine-pyrimethamine + artesunate
Chloroquine
Sponsored by
London School of Hygiene and Tropical Medicine
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malaria, Vivax focused on measuring Malaria, vivax, Afghanistan, Sulfadoxine-pyrimethamine, drug resistance

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • microscopy confirmed P. vivax mono-infection
  • age >2 years
  • weight >5kg
  • >1 asexual parasite per 10 fields

Exclusion Criteria:

  • pregnant
  • evidence of concomitant infection or serious disease
  • recent use of antimalarial drugs
  • severe malaria
  • known allergy to study drugs

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Proportion of patients with parasitological cure up to day 28 after treatment (defined as clearance of circulating vivax parasites by day 7 and absence until end of follow-up).

    Secondary Outcome Measures

    Parasite and fever clearance times, the proportion of patients free of parasites at 42 days, and the proportion of patients with detectable gametocytes during follow-up.

    Full Information

    First Posted
    June 13, 2007
    Last Updated
    June 13, 2007
    Sponsor
    London School of Hygiene and Tropical Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00486694
    Brief Title
    Artesunate Plus Sulfadoxine-Pyrimethamine Versus Chloroquine for Vivax Malaria
    Official Title
    A Randomised Non-Inferiority Trial of Sulfadoxine-Pyrimethamine Plus Artesunate Compared to Chloroquine for the Treatment of Vivax Malaria in Eastern Afghanistan.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    August 2004 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    London School of Hygiene and Tropical Medicine

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study was to determine whether the proposed first line treatment for falciparum malaria in this region (sulfadoxine-pyrimethamine + artesunate) would be no worse a treatment for vivax malaria that the standard vivax treatment of chloroquine. In areas where vivax and falciparum malaria co-exist misdiagnosis of vivax malaria as falciparum is not unlikely; it is important to know whether adequate treatment will be received in these cases.
    Detailed Description
    In areas co-endemic for falciparum and vivax malaria incorrect differential diagnosis is always a risk. Where the recommended treatment for the two diseases is the same this presents no problem for effective treatment or clinical cure of either species. Chloroquine remains an effective treatment of choice for vivax malaria in most settings, but with the spread of chloroquine-resistant falciparum malaria across Asia, many countries now use artemisinin-based combination therapy for this species of malaria. Differential diagnostic practices, have not improved in parallel. In Afghanistan the adoption of sulfadoxine-pyrimethamine plus artesunate (SP+AS) as first-line falciparum treatment raises the prospect of a significant proportion of vivax malaria being misdiagnosed and treated with the combination. SP is considered to have limited efficacy against vivax malaria and the efficacy of SP+AS against vivax has not been established in areas that have made the switch. A randomized, non-inferiority trial comparing SP+AS (1 day SP, 3 days AS) to chloroquine monotherapy was undertaken on 190 vivax patients in Eastern Afghanistan. A margin of equivalence of 14%, with 90% power and 95% CI (two-sided α = 0.05) was used. Standard WHO procedures for in vivo evaluation of antimalarial drugs were followed. 180 individuals completed the trial to day 42. The primary outcome was proportion of patients free from failure at day 28. Using a per protocol analysis both regimens resulted in ≥96% treatment success at 28 days, but significantly more cases failed in the CQ arm (46%) than in the SP+AS arm (24%) by day 42. Based on predetermined statistical criteria SP+AS was shown to be non-inferior to the standard chloroquine treatment. In areas where vivax infections might be misdiagnosed as falciparum infections and treated with SP+AS, patient management would be as good or better than with the standard CQ treatment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Malaria, Vivax
    Keywords
    Malaria, vivax, Afghanistan, Sulfadoxine-pyrimethamine, drug resistance

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    190 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Sulfadoxine-pyrimethamine + artesunate
    Intervention Type
    Drug
    Intervention Name(s)
    Chloroquine
    Primary Outcome Measure Information:
    Title
    Proportion of patients with parasitological cure up to day 28 after treatment (defined as clearance of circulating vivax parasites by day 7 and absence until end of follow-up).
    Secondary Outcome Measure Information:
    Title
    Parasite and fever clearance times, the proportion of patients free of parasites at 42 days, and the proportion of patients with detectable gametocytes during follow-up.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: microscopy confirmed P. vivax mono-infection age >2 years weight >5kg >1 asexual parasite per 10 fields Exclusion Criteria: pregnant evidence of concomitant infection or serious disease recent use of antimalarial drugs severe malaria known allergy to study drugs
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mark W Rowland, PhD
    Organizational Affiliation
    London School of Hygiene and Tropical Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17707447
    Citation
    Kolaczinski K, Durrani N, Rahim S, Rowland M. Sulfadoxine-pyrimethamine plus artesunate compared with chloroquine for the treatment of vivax malaria in areas co-endemic for Plasmodium falciparum and P. vivax: a randomised non-inferiority trial in eastern Afghanistan. Trans R Soc Trop Med Hyg. 2007 Nov;101(11):1081-7. doi: 10.1016/j.trstmh.2007.06.015. Epub 2007 Aug 17.
    Results Reference
    derived

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    Artesunate Plus Sulfadoxine-Pyrimethamine Versus Chloroquine for Vivax Malaria

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