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Completed

NCT Number: NCT00164255

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

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.

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Key information

Conditions

Malaria Birth Weight Body Weight Infections Mosquito-Borne Diseases Parasitic Diseases Pathological Conditions, Signs and Symptoms Protozoan Infections Signs and Symptoms Vector Borne Diseases

Age range

15 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Kibaoni Health Centre, Ifakara, Kilombero District, Tanzania

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sulfadoxine/pyrimethamine

Drug

sulfadoxine/pyrimethamine plus artesunate

Drug

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

Sponsors and collaborators

Lead sponsor

Centers for Disease Control and Prevention

Fed

Collaborators

  • Ifakara Health Research and Development Centre

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2009
Study completion
2009
First posted
Sep 14, 2005
Registry last updated
Sep 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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