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Pharmacokinetics, Efficacy, Gametocyte Carriage, Birth Outcomes Following Sulfadoxine-pyrimethamine Intermittent Presumptive Treatment in Pregnant Women

NCT ID: NCT00380146

Last Updated: 2016-10-26

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

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2008-03-31

Brief Summary

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The main purpose of this study is to compare the drug levels of sulfadoxine-pyrimethamine found when given to pregnant women for the prevention of malaria to those found in pregnant women given the same drug with artesunate for the treatment of malaria, and also with those drug levels found in non-pregnant women in other malaria treatment studies.

Detailed Description

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Pregnancy increases the risk of malaria progression and complications with up to a 10-fold increase in the malaria case fatality rate in areas of low transmission. Sulfadoxine-pyrimethamine (SP) is used widely in Africa for the systematic intermittent presumptive, or preventive, treatment (IPTp) during the second and third trimester of pregnancy and a national program of IPTp with SP has been implemented recently in Mozambique. There is evidence that the kinetics of several other antimalarial drugs are altered in pregnancy to the extent that doses are not adequate in pregnancy, however no published study has included a pharmacokinetic component to confirm that standard doses of SP are optimal in this vulnerable patient group. This study therefore creates the opportunity to study whether the pharmacokinetic properties of SP are altered by physiological changes that occur during pregnancy.

Conditions

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Malaria

Keywords

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Malaria Intermittent presumptive treatment IPT Pharmacokinetic Efficacy Gametocyte Molecular markers

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 plus artesunate

SP (Fansidar®, Roche South Africa) at a dose of 25/1.25mg/kg of sulfadoxine/pyrimethamine respectively on day 0 only, and artesunate (Arsumax®, Sanofi-Aventis, South Africa) at a dose of 4mg/kg on days 0, 1, and 2

Group Type EXPERIMENTAL

sulfadoxine-pyrimethamine

Intervention Type DRUG

Interventions

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sulfadoxine-pyrimethamine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Pregnant female, older than 18 years, \> 35kg.
* Gestational age \> 16 weeks (fundal height \> 16cm) and below 36 weeks gestation.
* Documented informed consent.
* Lives close enough to the study site for reliable follow up and is willing to attend ANC and follow-up visits regularly.

Exclusion Criteria

* Diagnoses of uncomplicated acute P. falciparum malaria parasitaemia
* Has received anti-malarial treatment in the past 7 days and/or sulfadoxine-pyrimethamine in the past 28 days.
* Known hepatic or renal impairment
* Has received chloramphenicol, cotrimoxazole or tetracyclines (including doxycycline) in the past 7 days or is likely to require these during the study period.
* History of G6PD deficiency.
* Has a history of allergy to any of the study drugs (including other sulphonamides e.g. cotrimoxazole).
* Serious underlying disease that in the opinion of the clinic team and/or Principal Investigator would make the patient unsuitable for the study in terms of their safety or study analysis.
* Imminent delivery expected.
* Prior inclusion in this study.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Global Fund

OTHER

Sponsor Role collaborator

Medical Research Council, South Africa

OTHER

Sponsor Role collaborator

Professor Karen I Barnes

OTHER

Sponsor Role lead

Responsible Party

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Professor Karen I Barnes

Professor, Clinical Pharmacology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Karen I Barnes, MBChB

Role: PRINCIPAL_INVESTIGATOR

University of Cape Town

Locations

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Ndlavela Health Centre

Ndlavela, Maputo, Mozambique

Site Status

Countries

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Mozambique

Other Identifiers

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SEACAT2.2

Identifier Type: -

Identifier Source: org_study_id