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NCT00140361 Clinical Trial

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

Malaria (Uncomplicated) Clinical Trial

Official title:
Assessing and Monitoring the Efficacy of Sulfadoxine/ Pyrimethamine (SP) and the Combination of SP Plus Artesunate for Uncomplicated Malaria Infections Among Children

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00140361
Other study ID # CDC-NCID-2577
Secondary ID UR3/CCU018969-01
Status Completed
Phase Phase 4
First received August 30, 2005
Last updated September 10, 2012
Start date January 2000
Est. completion date January 2008

Study information
Verified date September 2012
Source Centers for Disease Control and Prevention
Contact n/a
Is FDA regulated No
Health authority United States: Federal GovernmentTanzania: National Institute for Medical Research
Study type Interventional

Clinical Trial 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

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

Recruitment information / eligibility
Status Completed
Enrollment 390
Est. completion date January 2008
Est. primary completion date January 2008
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Sulfadoxine-pyrimethamine

• sulfadoxine-pyrimethamine plus artesunate

• lumefantrine plus artemether

Behavioral:
• Sleeping under insecticide-treated bednet

Locations
Country Name City State
Tanzania Ikwiriri Health Center Ikwiriri Rufiji
Tanzania Lupiro Health Center Lupiro Ulanga
Tanzania Ngere Ngere Health Center Ngere Ngere Morogoro Rural

Sponsors (2)
Lead Sponsor Collaborator
Centers for Disease Control and Prevention United States Agency for International Development (USAID)

Country where clinical trial is conducted

Tanzania, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical and parasitologic failure rate

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