Efficacy of Combination Therapy for Prevention of Effects of Malaria During Pregnancy

Centers for Disease Control and Prevention1,614 enrolled

Overview

This study is an investigation to compare the efficacy of two different intermittent sulfadoxine/pyrimethamine (SP) treatment regimens and intermittent sulfadoxine/pyrimethamine (SP) + artesunate (SP/AS) treatment of HIV negative and positive mothers in clearing placental parasitemia at delivery. If intermittent protective SP/AS treatment is equally efficacious and safe as intermittent protective SP, such a regimen could be adapted for programmatic use as a potentially more durable alternative to SP monotherapy in areas of increasing SP resistance.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

1,614

Conditions

Malaria

Interventions

sulfadoxine/pyrimethamineDRUG

sulfadoxine/pyrimethamine plus artesunateDRUG

Eligibility

Sex: FEMALEMin age: 15 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Women 15 years of age or older * First or second pregnancy between 16 and 36 weeks gestation Exclusion Criteria: * Pregnancy prior to 16 weeks or after 36 weeks gestation * Third or later pregnancy; * Report previous allergic reactions to SP, AS, or unknown antimalarials; * If the distance to their home is too great or too inaccessible for follow-up; * Child's father refuses the woman's participation

Locations (2)

Kibaoni Health Centre

Ifakara, Kilombero District, Tanzania

St Francis Designated District Hospital

Ifakara, Kilombero District, Tanzania

Outcomes

Primary Outcomes

placental parasitemia

reported or noted adverse reactions

Secondary Outcomes

parasitemia at delivery (maternal peripheral, placental and cord)

maternal illness

birth weight

gestational age

fetal and infant health

impact of maternal HIV infection on efficacy of malaria prevention during pregnancy

Data from ClinicalTrials.gov

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