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

Primary Purpose

Malaria

Status
Completed
Phase
Phase 4
Locations
Tanzania
Study Type
Interventional
Intervention
sulfadoxine/pyrimethamine
sulfadoxine/pyrimethamine plus artesunate
Sponsored by
Centers for Disease Control and Prevention
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Malaria focused on measuring malaria, birthweight, placental malaria, intermittent protective treatment, sulfadoxine/ pyrimethamine, artesuate, combination therapy, Pregnancy

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)FemaleAccepts 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

Sites / Locations

  • Kibaoni Health Centre
  • St Francis Designated District Hospital

Outcomes

Primary Outcome Measures

placental parasitemia
reported or noted adverse reactions

Secondary Outcome Measures

parasitemia at delivery (maternal peripheral, placental and cord)
maternal illness
birth weight
gestational age
fetal and infant health
impact of maternal HIV infection on efficacy of malaria prevention during pregnancy

Full Information

First Posted
September 9, 2005
Last Updated
September 10, 2012
Sponsor
Centers for Disease Control and Prevention
Collaborators
Ifakara Health Research and Development Centre
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1. Study Identification

Unique Protocol Identification Number
NCT00164255
Brief Title
Efficacy of Combination Therapy for Prevention of Effects of Malaria During Pregnancy
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 Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centers for Disease Control and Prevention
Collaborators
Ifakara Health Research and Development Centre

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria
Keywords
malaria, birthweight, placental malaria, intermittent protective treatment, sulfadoxine/ pyrimethamine, artesuate, combination therapy, Pregnancy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1614 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
sulfadoxine/pyrimethamine
Intervention Type
Drug
Intervention Name(s)
sulfadoxine/pyrimethamine plus artesunate
Primary Outcome Measure Information:
Title
placental parasitemia
Title
reported or noted adverse reactions
Secondary Outcome Measure Information:
Title
parasitemia at delivery (maternal peripheral, placental and cord)
Title
maternal illness
Title
birth weight
Title
gestational age
Title
fetal and infant health
Title
impact of maternal HIV infection on efficacy of malaria prevention during pregnancy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John MacArthur, MD, MPH
Organizational Affiliation
Centers for Disease Control and Prevention
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Salim Abdulla, MD, PhD
Organizational Affiliation
Ifakara Health Research and Development Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kibaoni Health Centre
City
Ifakara
State/Province
Kilombero District
Country
Tanzania
Facility Name
St Francis Designated District Hospital
City
Ifakara
State/Province
Kilombero District
Country
Tanzania

12. IPD Sharing Statement

Learn more about this trial

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

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