Efficacy of Sulphadoxine-pyrimethamine and Artemisinin-containing Combination Therapy for Malaria

Overview

This is an ongoing monitoring activity of efficacy of sulfadoxine-pyrimethamine (SP), which is the current national treatment of choice for uncomplicated malaria in Tanzania, and a combination of SP and artesunate among children < 5 years in 3 sites in rural Tanzania. Protocol was amended in 2004 to (1) include lumefantrine+artemether, the newly identified first-line treatment for malaria to be introduced into Tanzania in 2006; (2) on a limited basis, include adult patients; (3) extend follow-up to 28 days; (4) investigate whether treated bednets would reduce confounding by reinfection

Full Title of Study: “Assessing and Monitoring the Efficacy of Sulfadoxine/ Pyrimethamine (SP) and the Combination of SP Plus Artesunate for Uncomplicated Malaria Infections Among Children”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2008

Detailed Description

This is an ongoing monitoring activity of efficacy of sulfadoxine-pyrimethamine (SP), which is the current national treatment of choice for uncomplicated malaria in Tanzania, and a combination of SP and artesunate among children < 5 years in 3 sites in rural Tanzania. Protocol was amended in 2004 to (1) include lumefantrine+artemether, the newly identified first-line treatment for malaria to be introduced into Tanzania in 2006; (2) on a limited basis, include adult patients; (3) extend follow-up to 28 days; (4) investigate whether treated bednets would reduce confounding by reinfection

Interventions

  • Drug: Sulfadoxine-pyrimethamine
  • Drug: sulfadoxine-pyrimethamine plus artesunate
  • Drug: lumefantrine plus artemether
  • Behavioral: Sleeping under insecticide-treated bednet

Clinical Trial Outcome Measures

Primary Measures

  • Clinical and parasitologic failure rate

Participating in This Clinical Trial

Inclusion Criteria

Children < 5 years of age (in one site, patients of all ages are eligible). Documented fever (axillary temperature >= 37.5oC) in the absence of another obvious cause of fever or other serious or chronic medical condition Unmixed infection with P. falciparum of between 2,000 and 250,000 asexual parasites/mm3 Patients' or the patients' parent's or guardian's informed consent and willingness to participate in the study Exclusion Criteria:

Any evidence of severe malaria that would require hospitalization for treatment. Reported allergy to any antimalarial drugs, including sulfa and artemisinin drugs. History of pregnancy or delayed menstrual period Breastfeeding a child less than 8 weeks of age

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centers for Disease Control and Prevention
  • Collaborator
    • United States Agency for International Development (USAID)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Peter B Bloland, DVM, MPVM, Principal Investigator, Centers for Disease Control and Prevention
    • Salim Abdulla, MD, PhD, Study Director, Ifakara Health Research and Development Centre
    • John R MacArthur, MD, MPH, Study Director, Centers for Disease Control and Prevention

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