Sulfadoxine- Pyrimethamine Versus Weekly Chloroquine for Malaria Prevention in Children With Sickle Cell Anemia

NCT00399074 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2009-07-02

No results posted yet for this study

Summary

Malaria is fatal and increases the risk of death among children with sickle cell anemia. Chemoprophylaxis significantly improves quality of life in these children. In Uganda Chloroquine is the drug of choice for prophylaxis and yet it's effectiveness is limited due to high levels of resistance throughout the country. Intermittent presumptive treatment with sulfadoxine - Pyrimethamine a new approach to malaria prevention, has shown great potential in reducing incidence of malaria and anaemia among high risk groups such as pregnant women and infants. However no studies have been done in Uganda to determine if presumptive treatment with sulfadoxine- pyrimethamine reduces the incidence of malaria in children with sickle cell anaemia.

Hypothesis : Presumptive treatment with sulfadoxine- Pyrimethamine is better than weekly chloroquine in reducing incidence of malaria in children with sickle cell anaemia.

Conditions

Interventions

DRUG

sulfadoxine pyrimethamine

Monthly SP

Sponsors & Collaborators

  • Makerere University

    lead OTHER

Principal Investigators

  • Victoria Nakibuuka, MBChB · Department of Paediatrics and Child Health , Makerere University

  • Grace Ndeezi, M.Med · Department of Paediatrics and Child Health, Makerere University

  • Deborah Nakiboneka, M.Med · Department of Paediatrics and Child Health, Makerere University

  • Christopher Ndugwa, PhD · Department of paediatrics and Child Health, Makerere University

  • James Tumwine, PhD · Department of Paediatrics and Child Health, Makerere University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2007-02-28
Completion
2007-02-28

Countries

  • Uganda

Study Locations

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Entities

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 NCT00399074 on ClinicalTrials.gov