ClinicalTrials.Veeva

Menu

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

Centers for Disease Control and Prevention (CDC) logo

Centers for Disease Control and Prevention (CDC)

Status and phase

Completed
Phase 4

Conditions

Malaria

Treatments

Drug: sulfadoxine/pyrimethamine plus artesunate
Drug: sulfadoxine/pyrimethamine

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT00164255
UR3/CCU018969-01
CDC-NCID-3807

Details and patient eligibility

About

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.

Enrollment

1,614 patients

Sex

Female

Ages

15+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

2

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems