NCT00132548

Brief Summary

A recent study has shown that the administration of a single dose of sulfadoxine/pyrimethamine plus artesunate to Senegalese children on three occasions during a short malaria transmission season reduced the incidence of clinical attacks of malaria by 86%. However, use of this drug regimen led to the selection of parasites with molecular markers of resistance to pyrimethamine and sulfadoxine. Therefore, a trial of three alternative regimens has been undertaken to see if these are as effective and safe as the drug combination used in the initial study but less likely to select for drug resistance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,200

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2004

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

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

June 1, 2004

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 22, 2005

Completed
Last Updated

January 12, 2017

Status Verified

January 1, 2017

First QC Date

August 18, 2005

Last Update Submit

January 11, 2017

Conditions

Malaria

Keywords

MalariaChildrenIntermittent preventive treatmentSenegal

Outcome Measures

Primary Outcomes (1)

  • Prevalence of drug resistance

Secondary Outcomes (2)

  • Incidence of clinical malaria

  • Side effects

Interventions

Pyrimethamine/sulfadoxineDRUG
AmodiaquineDRUG
ArtesunateDRUG

Eligibility Criteria

Age1 Year - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Ages 1 - 5 years
  • Residence in the study area
  • Informed consent

You may not qualify if:

  • Known allergy to study drugs
  • Chronic, underlying illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de recherche pour le developpement

Dakar, BP 1386, Senegal

Location

Related Publications (1)

  • Sokhna C, Cisse B, Ba el H, Milligan P, Hallett R, Sutherland C, Gaye O, Boulanger D, Simondon K, Simondon F, Targett G, Lines J, Greenwood B, Trape JF. A trial of the efficacy, safety and impact on drug resistance of four drug regimens for seasonal intermittent preventive treatment for malaria in Senegalese children. PLoS One. 2008 Jan 23;3(1):e1471. doi: 10.1371/journal.pone.0001471.

    PMID: 18213379DERIVED

Related Links

MeSH Terms

Conditions

Malaria

Interventions

fanasil, pyrimethamine drug combinationAmodiaquineArtesunate

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

AminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsArtemisininsReactive Oxygen SpeciesFree RadicalsInorganic ChemicalsOrganic ChemicalsSesquiterpenesTerpenesHydrocarbons

Study Officials

  • Cheick Sokhna, PhD

    Institut de Recherche pour le Developpement, Senegal

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 18, 2005

First Posted

August 22, 2005

Study Start

June 1, 2004

Study Completion

December 1, 2004

Last Updated

January 12, 2017

Record last verified: 2017-01

Locations

SE(1)