- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00140361
Efficacy of Sulphadoxine-pyrimethamine and Artemisinin-containing Combination Therapy for Malaria
Assessing and Monitoring the Efficacy of Sulfadoxine/ Pyrimethamine (SP) and the Combination of SP Plus Artesunate for Uncomplicated Malaria Infections Among Children
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
Study Overview
Status
Conditions
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
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Morogoro Rural
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Ngere Ngere, Morogoro Rural, Tanzania
- Ngere Ngere Health Center
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Rufiji
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Ikwiriri, Rufiji, Tanzania
- Ikwiriri Health Center
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Ulanga
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Lupiro, Ulanga, Tanzania
- Lupiro Health Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Clinical and parasitologic failure rate
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Collaborators and Investigators
Investigators
- Study Director: John R MacArthur, MD, MPH, Centers for Disease Control and Prevention
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Infections
- Vector Borne Diseases
- Parasitic Diseases
- Protozoan Infections
- Malaria
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Antimalarials
- Anthelmintics
- Folic Acid Antagonists
- Schistosomicides
- Antiplatyhelmintic Agents
- Anti-Infective Agents, Urinary
- Renal Agents
- Lumefantrine
- Artemether
- Pyrimethamine
- Artesunate
- Sulfadoxine
- Fanasil, pyrimethamine drug combination
Other Study ID Numbers
- CDC-NCID-2577
- UR3/CCU018969-01
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