MedTrace Logo

Intermittent Preventive Treatment of Malaria in Schoolchildren

NCT00852371 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 780

Last updated 2024-03-21

Study results available
· View outcomes & findings →

Summary

This will be a randomized, single-blinded, placebo-controlled trial to evaluate the efficacy, safety and tolerability of antimalarial regimens in healthy schoolchildren. The primary objective of the study is to compare the efficacy of different combination antimalarial regimens, including amodiaquine + sulfadoxine-pyrimethamine (AQ+SP), dihydroartemisinin-piperaquine (DP), and placebo, to SP for intermittent preventive treatment (IPT) in schoolchildren, as measured by risk of parasitaemia (unadjusted by genotyping) after 42 days of follow-up. This will assess both the efficacy for treatment of asymptomatic infections and the efficacy for prevention of new infections.

Conditions

  • Malaria
  • Intermittent Preventive Treatment

Interventions

DRUG

sulfadoxine-pyrimethamine

25 mg/kg po once on day 0

DRUG

amodiaquine + sulfadoxine-pyrimethamine

Amodiaquine: 10 mg/kg po daily for 3 days (on days 0, 1, 2) SP: 25 mg/kg po once on day 0

DRUG

dihydroartemisinin-piperaquine

2.1/17.1 mg/kg daily for three days (on days 0, 1, 2)

OTHER

Placebo

dosed as for amodiaquine (10mg/kg po daily on days 1, 2)

Sponsors & Collaborators

  • Uganda Malaria Surveillance Project

    collaborator OTHER

  • Ministry of Health, Uganda

    collaborator OTHER_GOV

  • London School of Hygiene and Tropical Medicine

    lead OTHER

Principal Investigators

  • Sarah G Staedke, MD · London School of Hygiene and Tropical Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2008-06-30
Completion
2008-06-30

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 NCT00852371 on ClinicalTrials.gov