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Clin Infect Dis. 2016 Mar 15;62(6):761-769. doi: 10.1093/cid/civ991. Epub 2015 Dec 9.

Toward Earlier Inclusion of Pregnant and Postpartum Women in Tuberculosis Drug Trials: Consensus Statements From an International Expert Panel.

Author information

1
Division of Infectious Diseases and Department of International Health, Johns Hopkins University.
2
Division of Infectious Diseases, Center for Global Health Weill Cornell Medical College, New York, New York.
3
Division of Clinical Pharmacology, Children's Mercy Hospital, Kansas City, Missouri.
4
Post Approval & Strategic Services.
5
European Medicines Agency, London, United Kingdom.
6
Women's Health and Medical Affairs, INC Research, Raleigh.
7
Division of AIDS, National Institute of Allergy and Infectious Diseases.
8
Divisions of Clinical Pharmacology and Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore.
9
Instituto de Pesquisa Clinica Evandro Chagas-Fiocruz, Rio de Janeiro, Brazil.
10
Department of Epidemiology.
11
Department of Health and Human Services, HJF-DAIDS, a division of The Henry M. Jackson Foundation for the Advancement of Military Medicine, contractor to the National Institute of Allergy and Infectious Diseases.
12
University of North Carolina at Chapel Hill Center for Bioethics and Department of Social Medicine.
13
Department of Pediatrics, Boston University School of Medicine, Massachusetts.
14
Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health.
15
Department of Biostatistics, Center for Biostatistics in AIDS Research, Harvard T. H. Chan School of Public Health.
16
Division of Pediatric and Maternal Health, FDA Office of New Drugs, Silver Spring, Maryland.
17
Department of Bioengineering and Therapeutic Sciences, Schools of Pharmacy and Medicine, University of California San Francisco.
18
National Institute for Research in Tuberculosis, Chennai, India.
19
Office of the Global AIDS Coordinator, US Department of State, Washington D.C.
20
Department of Bioethics, NIH Clinical Center, Bethesda.

Abstract

Tuberculosis is a major cause of morbidity and mortality in women of childbearing age (15-44 years). Despite increased tuberculosis risk during pregnancy, optimal clinical treatment remains unclear: safety, tolerability, and pharmacokinetic data for many tuberculosis drugs are lacking, and trials of promising new tuberculosis drugs exclude pregnant women. To advance inclusion of pregnant and postpartum women in tuberculosis drug trials, the US National Institutes of Health convened an international expert panel. Discussions generated consensus statements (>75% agreement among panelists) identifying high-priority research areas during pregnancy, including: (1) preventing progression of latent tuberculosis infection, especially in women coinfected with human immunodeficiency virus; (2) evaluating new agents/regimens for treatment of multidrug-resistant tuberculosis; and (3) evaluating safety, tolerability and pharmacokinetics of tuberculosis drugs already in use during pregnancy and postpartum. Incorporating pregnant women into clinical trials would extend evidence-based tuberculosis prevention and treatment standards to this special population.

KEYWORDS:

MDR tuberculosis; clinical trials; latent tuberculosis infection; pregnancy; tuberculosis

PMID:
26658057
PMCID:
PMC4772846
DOI:
10.1093/cid/civ991
[Indexed for MEDLINE]
Free PMC Article

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