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

NCT00140361 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 390

Last updated 2012-09-11

No results posted yet for this study

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)

Interventions

DRUG

Sulfadoxine-pyrimethamine

DRUG

sulfadoxine-pyrimethamine plus artesunate

DRUG

lumefantrine plus artemether

BEHAVIORAL

Sleeping under insecticide-treated bednet

Sponsors & Collaborators

Principal Investigators

  • Peter B Bloland, DVM, MPVM · Centers for Disease Control and Prevention

  • Salim Abdulla, MD, PhD · Ifakara Health Research and Development Centre

  • John R MacArthur, MD, MPH · Centers for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-01-31
Primary Completion
2008-01-31
Completion
2008-01-31

Countries

  • Tanzania

Study Locations

More Related Trials

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 NCT00140361 on ClinicalTrials.gov