Trial intelligence / Profile preview

IPTi with Sulfadoxine-Pyrimethamine in Children

NCT00168948Phase 4

Key facts

Status
Unknown
Start
Mar 2003
Sponsor
Charité – Universitätsmedizin Berlin
Modality
Small Molecules
Conditions
malariaanemia
01

Overview

Phase 4, randomised, double-blind trial in malaria and anemia comparing Sulfadoxine-Pyrimethamine with Placebo (2 arms). Primary endpoints: Incidence of malaria attacks at 24 months, Impact on anemia at 24 months and 1 more. Status: unknown.

02

Design

2 arms
Study design
RandomizedDouble-blind
  • Sulfadoxine-Pyrimethamine

    Intermittent Preventive Treatment with SP

  • Placebo

    Placebo

03

Who it enrols

Infants >2 months of age with no concomitant serious disease and no allergy to sulfonamides.

04

Endpoints

Primary

  • Incidence of malaria attacks

  • Impact on anemia

  • Efficacy and safety of IPTi with SP

Secondary

  • Influence on parasite multiplicity

  • Impact on child development

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