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
About this trial
This is an interventional treatment trial for Malaria, Vivax focused on measuring Malaria, vivax, Afghanistan, Sulfadoxine-pyrimethamine, drug resistance
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
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
NCT ID
NCT00486694
First Posted
June 13, 2007
Last Updated
June 13, 2007
Sponsor
London School of Hygiene and Tropical Medicine
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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