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

Malaria Clinical Trial

Official title:

Efficacy of Intermittent Sulfadoxine-Pyrimethamine and Sulfadoxine-Pyrimethamine + Artesunate Treatment in the Prevention of Malaria in Pregnancy in an Area With Chloroquine-Resistant Plasmodium Falciparum

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00164255
• Other study ID #: CDC-NCID-3807
• Secondary ID: UR3/CCU018969-01
• Status: Completed
• Phase: Phase 4
• First received: September 9, 2005
• Last updated: September 10, 2012
• Start date: January 2003
• Est. completion date: June 2009

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1614
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Malaria

Intervention

Drug:
• sulfadoxine/pyrimethamine

• sulfadoxine/pyrimethamine plus artesunate

Locations

Country	Name	City	State
Tanzania	Kibaoni Health Centre	Ifakara	Kilombero District
Tanzania	St Francis Designated District Hospital	Ifakara	Kilombero District

Sponsors (2)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention	Ifakara Health Research and Development Centre

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	placental parasitemia
Primary	reported or noted adverse reactions
Secondary	parasitemia at delivery (maternal peripheral, placental and cord)
Secondary	maternal illness
Secondary	birth weight
Secondary	gestational age
Secondary	fetal and infant health
Secondary	impact of maternal HIV infection on efficacy of malaria prevention during pregnancy