Sulphadoxine-Pyrimethamine for Intermittent Preventive Treatment of Malaria in Pregnancy in Uganda

NCT ID: NCT01184911

Last Updated: 2015-03-05

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

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-09-30

Brief Summary

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The effectiveness of sulfadoxine-pyrimethamine (SP) as intermittent preventive treatment in pregnancy in malaria-endemic areas the effectiveness and efficacy of SP may be compromised by increased SP resistance. This study will evaluate the efficacy of SP by giving SP to asymptomatic parasitemic pregnant women and following them to determine the rates of parasite clearance.

Detailed Description

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Conditions

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Intermittent Preventive Treatment Placental Malaria

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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SP

Asymptomatic parasitemic pregnant women who receive the standard dose of sulfadoxine-pyrimethamine for prevention of placental malaria

Group Type EXPERIMENTAL

Sulfadoxine-pyrimethamine

Intervention Type DRUG

Sulfadoxine-pyrimethamine tablets, once

Interventions

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Sulfadoxine-pyrimethamine

Sulfadoxine-pyrimethamine tablets, once

Intervention Type DRUG

Other Intervention Names

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Kamsidar, Fansidar

Eligibility Criteria

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Inclusion Criteria

* 16-26 weeks gestation based on LMP or ultrasound or fundal height
* Axillary temperature \<37.5 degrees C
* Informed consent
* HIV status known and negative
* Blood smear positive for falciparum malaria

Exclusion Criteria

* History of hypersensitivity reaction to SP or components of SP
* Axillary temperature ≥37.5 degrees C
* History of receipt of antimalarials or antibiotics with antimalarial activity\* in the past month
* Residence \> 30 km from the ANC clinic or unwillingness to return for follow-up visits
* Hemoglobin level \< 5 gm/dL

* These medications include all antimalarials, rifampin, doxycycline, clindamycin, tetracycline, erythromycin, azithromycin, chloramphenicol.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centers for Disease Control and Prevention

FED

Sponsor Role collaborator

Uganda Malaria Surveillance Project

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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University of California San Francisco

Principal Investigators

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Veronica Ades, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Scott Filler, MD, DTM&H

Role: PRINCIPAL_INVESTIGATOR

Centers for Disease Control and Prevention

Moses Kamya, MBChB, MMed, MPH, PhD

Role: PRINCIPAL_INVESTIGATOR

Uganda Malaria Surveillance Project

Locations

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Infectious Disease Research Center

Tororo, Tororo, Uganda

Site Status

Countries

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Uganda

Related Links

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Other Identifiers

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CDC5972

Identifier Type: -

Identifier Source: org_study_id

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