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

NCT00140361 | Completed Phase 4

• 2 other identifiers: CDC-NCID-2577UR3/CCU018969-01
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Malaria (Uncomplicated)

Keywords

malaria; sulfadoxine-pyrimethamine; sulfadoxine-pyrimethamine plus artsunate; lumefantrine plus artemether; combination therapy

Outcome Measures

Primary Outcomes (1)

• Clinical and parasitologic failure rate

Interventions

Sulfadoxine-pyrimethamine DRUG

sulfadoxine-pyrimethamine plus artesunate DRUG

lumefantrine plus artemether DRUG

Sleeping under insecticide-treated bednet BEHAVIORAL

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centers for Disease Control and Prevention: lead
• United States Agency for International Development (USAID): collaborator

Study Sites (3)

Ngere Ngere Health Center

Ngerengere, Morogoro Rural, Tanzania

Location

Ikwiriri Health Center

Ikwiriri, Rufiji, Tanzania

Location

Lupiro Health Center

Lupiro, Ulanga, Tanzania

Location

MeSH Terms

Conditions

Malaria

Interventions

fanasil, pyrimethamine drug combination; Artesunate; Lumefantrine; Artemether

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Artemisinins; Reactive Oxygen Species; Free Radicals; Inorganic Chemicals; Organic Chemicals; Sesquiterpenes; Terpenes; Hydrocarbons; Fluorenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds

Study Officials

• Peter B Bloland, DVM, MPVM

  Centers for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

• Salim Abdulla, MD, PhD

  Ifakara Health Research and Development Centre

  STUDY DIRECTOR

• John R MacArthur, MD, MPH

  Centers for Disease Control and Prevention

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2005
• First Posted: September 1, 2005
• Study Start: January 1, 2000
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: September 11, 2012

Record last verified: 2012-09

Locations

TA (3)