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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1614 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2009-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Malaria

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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sulfadoxine/pyrimethamine

Intervention Type DRUG

sulfadoxine/pyrimethamine plus artesunate

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

15 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John MacArthur, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Centers for Disease Control and Prevention

Salim Abdulla, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ifakara Health Research and Development Centre

Locations

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Kibaoni Health Centre

Ifakara, Kilombero District, Tanzania

Site Status

St Francis Designated District Hospital

Ifakara, Kilombero District, Tanzania

Site Status

Countries

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Tanzania

References

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Pons-Duran C, Wassenaar MJ, Yovo KE, Marin-Carballo C, Briand V, Gonzalez R. Intermittent preventive treatment regimens for malaria in HIV-positive pregnant women. Cochrane Database Syst Rev. 2024 Sep 26;9(9):CD006689. doi: 10.1002/14651858.CD006689.pub3.

Reference Type DERIVED

PMID: 39324693 (View on PubMed)

Other Identifiers

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UR3/CCU018969-01

Identifier Type: -

Identifier Source: secondary_id

CDC-NCID-3807