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Dihydroartemisinin (DHA)-Piperaquine for IPT to Prevent Malaria in Children in Burkina Faso

NCT00941785 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 1500

Last updated 2011-03-21

No results posted yet for this study

Summary

The aim of the study is to determine whether piperaquine plus dihydroartemisinin (DHA-PQ) is as effective, and better tolerated, than sulfadoxine-pyrimethamine plus amodiaquine (SP+AQ), when used for seasonal Intermittent Preventive Treatment (IPT) to prevent malaria in children aged 3 to 59 months in Bobo-Dioulasso, Burkina Faso and to determine the pharmacokinetics of piperaquine in children.

Conditions

Interventions

DRUG

DHA-PQ

Three monthly administrations of Duocotexcin (DHA-PQ): dihydroartemisinin 2.1mg/kg and piperaquine phosphate 16.8 mg/kg once daily for three days

DRUG

SP-AQ

Three monthly administrations of sulfadoxine-pyrimethamine plus amodiaquine: One dose of Sulfadoxine 25mg/kg and pyrimethamine 1.25mg/kg Three daily doses of amodiaquine phosphate 10mg/kg

Sponsors & Collaborators

  • BEIJING HOLLEY-COTEC PHARMACEUTICALS CO. LTD.

    collaborator UNKNOWN

  • London School of Hygiene and Tropical Medicine

    lead OTHER

Principal Investigators

  • Jean-Bosco Ouédraogo, MD · IRSS, Direction Régionale,BP 545 Bobo-Dioulasso (Burkina Faso)

  • Paul JM Milligan, PhD · London School of Hygiene and Tropical Medicine

  • Issaka Zongo, MD · IRSS, Burkina Faso and LSHTM, UK

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • Burkina Faso

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00941785 on ClinicalTrials.gov