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

NCT ID: NCT00140361

Last Updated: 2012-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

390 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-01-31

Study Completion Date

2008-01-31

Brief Summary

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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

Detailed Description

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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

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Malaria (Uncomplicated)

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Sulfadoxine-pyrimethamine

Intervention Type DRUG

sulfadoxine-pyrimethamine plus artesunate

Intervention Type DRUG

lumefantrine plus artemether

Intervention Type DRUG

Sleeping under insecticide-treated bednet

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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United States Agency for International Development (USAID)

FED

Sponsor Role collaborator

Centers for Disease Control and Prevention

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter B Bloland, DVM, MPVM

Role: PRINCIPAL_INVESTIGATOR

Centers for Disease Control and Prevention

Salim Abdulla, MD, PhD

Role: STUDY_DIRECTOR

Ifakara Health Research and Development Centre

John R MacArthur, MD, MPH

Role: STUDY_DIRECTOR

Centers for Disease Control and Prevention

Locations

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Ngere Ngere Health Center

Ngerengere, Morogoro Rural, Tanzania

Site Status

Ikwiriri Health Center

Ikwiriri, Rufiji, Tanzania

Site Status

Lupiro Health Center

Lupiro, Ulanga, Tanzania

Site Status

Countries

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Tanzania

Other Identifiers

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UR3/CCU018969-01

Identifier Type: -

Identifier Source: secondary_id

CDC-NCID-2577

Identifier Type: -

Identifier Source: org_study_id