Study of Pharmacokinetics and Pharmacodynamics of Artesunate in Pregnant Women in the Democratic Republic of Congo

Summary

The objective of this study is to assess the pharmacokinetics (PK) and pharmacodynamics (PD) of a standard dose of orally administered artesunate, in order to determine if the current adult dose (200 mg) is appropriate in parasitemic pregnant women when compared to the same women at three months postpartum and to parasitemic non-pregnant women. Preliminary evidence on safety, tolerability and efficacy will be gathered.

Conditions

• Malaria

Interventions

DRUG

Artesunate

A 200 mg dose of orally administered artesunate at the beginning of a 48-hour clinical sampling period.

Sponsors & Collaborators

• Global Network for Women's and Children's Health Research

  collaborator OTHER

• Bill and Melinda Gates Foundation

  collaborator OTHER

• Fogarty International Center of the National Institute of Health

  collaborator NIH

• National Center for Complementary and Integrative Health (NCCIH)

  collaborator NIH

• National Institute of Dental and Craniofacial Research (NIDCR)

  collaborator NIH

• National Cancer Institute (NCI)

  collaborator NIH

• RTI International

  collaborator OTHER

• University of North Carolina

  collaborator OTHER

• Kinshasa School of Public Health

  collaborator OTHER

• NICHD Global Network for Women's and Children's Health

  lead NETWORK

Principal Investigators

• Carl Bose, M.D. · University of North Carolina

• Antoinette Tshefu, M.D., M.P.H. · Kinshasa School of Public Health

Study Design

Allocation

NON_RANDOMIZED

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2007-05-31

Primary Completion

2008-11-30

Completion

2008-12-31

Countries

• Democratic Republic of the Congo

Study Locations