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CompletedNCT00164255Updated Sep 11, 2012

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

A Phase 4 interventional study of sulfadoxine/pyrimethamine and sulfadoxine/pyrimethamine plus artesunate in Malaria, sponsored by Centers for Disease Control and Prevention. Completed at 2 sites in Tanzania. Open to female participants aged 15 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-09-11.

Sponsored by Centers for Disease Control and Prevention · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
1,614
Allocation
Randomized
Ages
15 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Malaria

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Keywords

  • malaria
  • birthweight
  • placental malaria
  • intermittent protective treatment
  • sulfadoxine/ pyrimethamine
  • artesuate
  • combination therapy
  • Pregnancy
03

In context

Malaria

1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.

This study's enrollment of 1,614 is above the median of 220 across 1,027 interventional studies indexed under Malaria.

Browse Malaria studies →

Lead sponsor

Centers for Disease Control and Prevention is the lead sponsor of 273 studies on the registry; 2 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 8 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Women 15 years of age or older
  • First or second pregnancy between 16 and 36 weeks gestation

Exclusion criteria

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
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Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,614 participants (actual)

Interventions

  • Drugsulfadoxine/pyrimethamine
  • Drugsulfadoxine/pyrimethamine plus artesunate
06

What researchers measure

Primary outcomes

  1. placental parasitemia

  2. reported or noted adverse reactions

Secondary outcomes

  1. parasitemia at delivery (maternal peripheral, placental and cord)

  2. maternal illness

  3. birth weight

  4. gestational age

  5. fetal and infant health

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

07

Study locations

2 sites
  • Kibaoni Health Centre
    Ifakara, Kilombero District, Tanzania
  • St Francis Designated District Hospital
    Ifakara, Kilombero District, Tanzania
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 11, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00164255
Lead sponsor
Centers for Disease Control and Prevention
Collaborators
Ifakara Health Research and Development Centre
Responsible party
Sponsor
First posted
Sep 14, 2005
Start date
Jan 2003
Primary completion
Jun 2009
Completion
Jun 2009
Last update
Sep 11, 2012

Study contacts

John MacArthur, MD, MPH
principal investigator · Centers for Disease Control and Prevention
Salim Abdulla, MD, PhD
principal investigator · Ifakara Health Research and Development Centre

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.

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