Clinical trial NCT00140361: Efficacy of Sulphadoxine-pyrimethamine and Artemisinin-containing Combination Therapy for Malaria
Official title: Assessing and Monitoring the Efficacy of Sulfadoxine/ Pyrimethamine (SP) and the Combination of SP Plus Artesunate for Uncomplicated Malaria Infections Among Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Malaria (Uncomplicated)
Keywords: malaria
sulfadoxine-pyrimethamine
sulfadoxine-pyrimethamine plus artsunate
lumefantrine plus artemether
combination therapy
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: United States Agency for International Development (USAID)
First posted: 2005-09-01
Enrollment: 390
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Eligibility criteria: 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

Primary outcomes:
measure: Clinical and parasitologic failure rate
Secondary outcomes:
Other outcomes:
Locations:
city: Ngere Ngere
country: Tanzania
facility: Ngere Ngere Health Center
state: Morogoro Rural
city: Ikwiriri
country: Tanzania
facility: Ikwiriri Health Center
state: Rufiji
city: Lupiro
country: Tanzania
facility: Lupiro Health Center
state: Ulanga
Study officials:
affiliation: Centers for Disease Control and Prevention
name: Peter B Bloland, DVM, MPVM
role: PRINCIPAL_INVESTIGATOR
affiliation: Ifakara Health Research and Development Centre
name: Salim Abdulla, MD, PhD
role: STUDY_DIRECTOR
affiliation: Centers for Disease Control and Prevention
name: John R MacArthur, MD, MPH
role: STUDY_DIRECTOR
References: