NCT00486694

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2004

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

June 13, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 15, 2007

Completed
Last Updated

June 15, 2007

Status Verified

June 1, 2007

First QC Date

June 13, 2007

Last Update Submit

June 13, 2007

Conditions

Malaria, Vivax

Keywords

Malaria, vivaxAfghanistanSulfadoxine-pyrimethaminedrug resistance

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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.

Interventions

Sulfadoxine-pyrimethamine + artesunateDRUG
ChloroquineDRUG

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 17707447DERIVED

MeSH Terms

Conditions

Malaria, Vivax

Interventions

sulfadoxine-pyrimethamine-artesunateChloroquine

Condition Hierarchy (Ancestors)

MalariaProtozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

AminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Mark W Rowland, PhD

    London School of Hygiene and Tropical Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 13, 2007

First Posted

June 15, 2007

Study Start

March 1, 2004

Study Completion

August 1, 2004

Last Updated

June 15, 2007

Record last verified: 2007-06