Evidence map›Paper›PMID 26658057›Full record

ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2016

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

Amita Gupta, Jyoti S Mathad, Susan M Abdel-Rahman, Jessica D Albano, Radu Botgros, Vikki Brown, Renee S Browning, Liza Dawson, Kelly E Dooley, Devasena Gnanashanmugam and 16 more

Open access · bronzeAbstract readConsensus Development Conference, NIH
In one paragraph

Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 4 pooled it
2.3field-weighted citation impact, top 11% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

33 citing papers in PubMed, 4 syntheses or guidelines pooled it, 62 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Treatment of Drug-Resistant Tuberculosis. An Official ATS/CDC/ERS/IDSA Clinical Practice Guideline.American journal of respiratory and critical care medicine · 2019
    Guideline
  4. Guideline
  5. Trial
  6. Individual and Composite Adverse Pregnancy Outcomes in a Randomized Trial on Isoniazid Preventative Therapy Among Women Living With Human Immunodeficiency Virus.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2021
    Trial
  7. Trial
  8. Trial
  9. Article
  10. Article
  11. Adverse Pregnancy Outcomes Among Women with Human Immunodeficiency Virus Taking Isoniazid Preventive Therapy During the First Trimester.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024
    Article
  12. Article
  13. Article
  14. Article
  15. The effect of antenatal isoniazid preventive therapy on birth outcomes in Western Kenya.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2023
    Article
  16. Article
  17. Best practices for the care of pregnant people living with TB.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2023
    Review
  18. Article
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

26 authors at 14 institutions in 3 countries.

Amita GuptaDivision of Infectious Diseases and Department of International Health, Johns Hopkins University.
Jyoti S MathadDivision of Infectious Diseases, Center for Global Health Weill Cornell Medical College, New York, New York.
Susan M Abdel-RahmanDivision of Clinical Pharmacology, Children's Mercy Hospital, Kansas City, Missouri.
Jessica D AlbanoPost Approval & Strategic Services.
Radu BotgrosEuropean Medicines Agency, London, United Kingdom.
Vikki BrownWomen's Health and Medical Affairs, INC Research, Raleigh.
Renee S BrowningDivision of AIDS, National Institute of Allergy and Infectious Diseases.
Liza DawsonDivision of AIDS, National Institute of Allergy and Infectious Diseases.
Kelly E DooleyDivisions of Clinical Pharmacology and Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore.
Devasena GnanashanmugamDivision of AIDS, National Institute of Allergy and Infectious Diseases.
Beatriz GrinsztejnInstituto de Pesquisa Clinica Evandro Chagas-Fiocruz, Rio de Janeiro, Brazil.
Sonia Hernandez-DiazDepartment of Epidemiology.
Patrick Jean-PhilippeDepartment 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.
Peter KimDivision of AIDS, National Institute of Allergy and Infectious Diseases.
Anne D LyerlyUniversity of North Carolina at Chapel Hill Center for Bioethics and Department of Social Medicine.
Mark MirochnickDepartment of Pediatrics, Boston University School of Medicine, Massachusetts.
Lynne M MofensonEunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health.
Grace MontepiedraDepartment of Biostatistics, Center for Biostatistics in AIDS Research, Harvard T. H. Chan School of Public Health.
Jeanna PiperDivision of AIDS, National Institute of Allergy and Infectious Diseases.
Leyla SahinDivision of Pediatric and Maternal Health, FDA Office of New Drugs, Silver Spring, Maryland.
Radojka SavicDepartment of Bioengineering and Therapeutic Sciences, Schools of Pharmacy and Medicine, University of California San Francisco.
Betsy SmithDivision of AIDS, National Institute of Allergy and Infectious Diseases.
Hans SpiegelDepartment 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.
Soumya SwaminathanNational Institute for Research in Tuberculosis, Chennai, India.
D Heather WattsOffice of the Global AIDS Coordinator, US Department of State, Washington D.C.
Amina WhiteDepartment of Bioethics, NIH Clinical Center, Bethesda.
National Institute of Allergy and Infectious Diseases · USJohns Hopkins University · USBoston University · USCancer Research And Biostatistics · USChildren's Mercy Hospital · USCornell University · USHenry M. Jackson Foundation · USINC Research (United States) · USInstituto Evandro Chagas · BRNational Institute of Research in Tuberculosis · INNational Institutes of Health · USNational Institutes of Health Clinical Center · USUniversity of California, San Francisco · USUniversity of North Carolina at Chapel Hill · US

Funding

LOC-IMPAACT Leadership GroupPharmacokinetics and Safety of Remdesivir for Treatment of COVID-19 in Pregnant Women in the USUM1AI068632 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI Sharon A Nachman · 2011 to 2026
$278.1M
Statistical and Data Management Center-Pediatric,Adolescent, and Maternal CTGUM1AI068616 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI Sean Scott Brummel, Marlene Ann Cooper · 2011 to 2026
$155.6M
The FIOCRUZ Therapeutic and Prevention HIV/AIDS Clinical Trials Unit (FioTrials)UM1AI069476 · NIAID · FUNDACAO OSWALDO CRUZ · PI BEATRIZ GRINSZTEJN · 2012 to 2026
$26.3M
T32: Pathogenesis of Infectious Diseases Training ProgramT32AI007613 · NIAID · WEILL MEDICAL COLL OF CORNELL UNIV · PI ROY M. GULICK · 1999 to 2026
$8.8M
Clinical Pharmacology Training ProgramT32GM066691 · NIGMS · JOHNS HOPKINS UNIVERSITY · PI Matthew Michael Ippolito · 2003 to 2026
$6.4M
NIAID NIH HHS HHSN272200800014CNIAID NIH HHS T32 AI007613NIAID NIH HHS UM1 AI068616NIAID NIH HHS UM1 AI068632NIAID NIH HHS UM1 AI069476NIGMS NIH HHS T32 GM066691PHS HHS HHSN272200800014C
6 · The paper itself

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.

Indexed as

Postpartum PeriodAdultAntitubercular AgentsClinical Trials as TopicFemaleHIV InfectionsHumansLatent TuberculosisPregnancyTuberculosisTuberculosis, Multidrug-ResistantUnited StatesAntitubercular Agentsclinical trialslatent tuberculosis infectionMDR tuberculosispregnancytuberculosis

Identifiers

PMID26658057
PMCPMC4772846
OpenAlexW2292713324

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.