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. 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

Amita Gupta  1 , Jyoti S Mathad  2 , Susan M Abdel-Rahman  3 , Jessica D Albano  4 , Radu Botgros  5 , Vikki Brown  6 , Renee S Browning  7 , Liza Dawson  7 , Kelly E Dooley  8 , Devasena Gnanashanmugam  7 , Beatriz Grinsztejn  9 , Sonia Hernandez-Diaz  10 , Patrick Jean-Philippe  11 , Peter Kim  7 , Anne D Lyerly  12 , Mark Mirochnick  13 , Lynne M Mofenson  14 , Grace Montepiedra  15 , Jeanna Piper  7 , Leyla Sahin  16 , Radojka Savic  17 , Betsy Smith  7 , Hans Spiegel  11 , Soumya Swaminathan  18 , D Heather Watts  19 , Amina White  20
Affiliations

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

Amita Gupta et al. Clin Infect Dis. .

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.

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References

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