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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00164255
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : September 11, 2012
Sponsor:
Collaborator:
Ifakara Health Research and Development Centre
Information provided by (Responsible Party):
Centers for Disease Control and Prevention

Brief 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.

Condition or disease Intervention/treatment Phase
Malaria Drug: sulfadoxine/pyrimethamine Drug: sulfadoxine/pyrimethamine plus artesunate Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1614 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Study Start Date : January 2003
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria




Primary Outcome Measures :
  1. placental parasitemia
  2. reported or noted adverse reactions

Secondary Outcome Measures :
  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


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00164255


Locations
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Tanzania
Kibaoni Health Centre
Ifakara, Kilombero District, Tanzania
St Francis Designated District Hospital
Ifakara, Kilombero District, Tanzania
Sponsors and Collaborators
Centers for Disease Control and Prevention
Ifakara Health Research and Development Centre
Investigators
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Principal Investigator: John MacArthur, MD, MPH Centers for Disease Control and Prevention
Principal Investigator: Salim Abdulla, MD, PhD Ifakara Health Research and Development Centre
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Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT00164255    
Other Study ID Numbers: CDC-NCID-3807
UR3/CCU018969-01
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: September 11, 2012
Last Verified: September 2012
Keywords provided by Centers for Disease Control and Prevention:
malaria
birthweight
placental malaria
intermittent protective treatment
sulfadoxine/ pyrimethamine
artesuate
combination therapy
Pregnancy
Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases
Artesunate
Pyrimethamine
Sulfadoxine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents