Evidence map›Paper›PMID 29393655›Full record

Trial reportAnnals of the American Thoracic Society2018

Exposure to Latent Tuberculosis Treatment during Pregnancy. The PREVENT TB and the iAdhere Trials.

Ruth N Moro, Nigel A Scott, Andrew Vernon, Naomi K Tepper, Stefan V Goldberg, Kevin Schwartzman, Chi-Chiu Leung, Neil W Schluger, Robert W Belknap, Richard E Chaisson and 6 more

3 registry-linked trialsAbstract readClinical Trial, Phase IIIClinical Trial, Phase IVMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of the American Thoracic Society, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 34 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 5 pooled it
–field-weighted citation impact
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.

NCT00023452 phase3completednot on this map

TBTC Study 26: Effectiveness and Tolerability of Weekly Rifapentine/Isoniazid for 3 Months Versus Daily Isoniazid for 9 Months for the Treatment of Latent Tuberculosis Infection

TypeinterventionalSponsorCenters for Disease Control and PreventionRan2001 to 2013Enrolled8,053ConditionsTuberculosisArmsRPT + INH once weekly for 3 months given by DOT, Isoniazid (INH) daily for 9 months
NCT01582711 phase3completednot on this map

TBTC Study 33. An Evaluation of Adherence to Latent Tuberculosis Infection (LTBI) Treatment With 12 Doses of Once Weekly Rifapentine (RPT) and Isoniazid (INH) Given as Self-administered (SAT) Versus Directly-observed Therapy (DOT): iAdhere.

TypeinterventionalSponsorCenters for Disease Control and PreventionRan2012 to 2014Enrolled1,002ConditionsLatent Tuberculosis InfectionArmsSelf Administered Therapy (SAT), SMS reminders, isoniazid and rifapentine
NCT06253715 phase3recruitingnot on this mapstarted 2025, after this paper: background citation

Shortened Regimen for Drug-susceptible TB in Children

TypeinterventionalSponsorJohns Hopkins UniversityRan2025 to 2027Enrolled860ConditionsTuberculosis, Tuberculosis, Pulmonary, Tuberculosis, Lymph Node, Mycobacterium TuberculosisArmsIsoniazid, Rifampin, Pyrazinamide, Ethambutol, Rifapentine
3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 5 syntheses or guidelines pooled it.

  1. Pooled it
  2. Guideline
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Trial
  7. Pharmacokinetics and Safety of 3 Months of Weekly Rifapentine and Isoniazid for Tuberculosis Prevention in Pregnant Women.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022
    Trial
  8. Trial
  9. Article
  10. Tuberculosis Preventive Treatment for Pregnant People With HIV in South Africa: A Modeling Analysis of Clinical Benefits and Risks.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
    Article
  11. Review
  12. Article
  13. 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
  14. Article
  15. Review
  16. Article
  17. Review
  18. Review
  19. Review
  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

16 authors.

Ruth N Moro1 Centers for Disease Control and Prevention (CDC), Atlanta, Georgia.
Nigel A Scott1 Centers for Disease Control and Prevention (CDC), Atlanta, Georgia.
Andrew Vernon1 Centers for Disease Control and Prevention (CDC), Atlanta, Georgia.
Naomi K Tepper1 Centers for Disease Control and Prevention (CDC), Atlanta, Georgia.
Stefan V Goldberg1 Centers for Disease Control and Prevention (CDC), Atlanta, Georgia.
Kevin Schwartzman3 McGill University Health Centre, Respiratory Epidemiology and Clinical Research Unit, Montreal, Quebec, Canada.
Chi-Chiu Leung4 Tuberculosis and Chest Service, Department of Health, Hong Kong, China.
Neil W Schluger5 Division of Pulmonary, Allergy and Critical Care Medicine, Columbia University Medical Center, New York, New York.
Robert W Belknap6 Denver Health and Hospitals, Denver, Colorado.
Richard E Chaisson7 Johns Hopkins University School of Medicine, Center for Tuberculosis Research, Baltimore, Maryland.
Masahiro Narita8 Division of Pulmonary and Critical Care Medicine, University of Washington, Seattle, Washington.
Elizabeth S Machado10 Universidad Federal do Rio de Janeiro, Rio de Janeiro, Brazil.
Marta Lopez11 Maternal-Fetal Medicine Department, Hospital Clinic and Hospital Sant Joan de Déu, University of Barcelona, Barcelona, Spain.
Jorge Sanchez12 Asociación Civil IMPACTA Salud y Educación, Lima, Peru.
Margarita E Villarino1 Centers for Disease Control and Prevention (CDC), Atlanta, Georgia.
Timothy R Sterling14 Vanderbilt University Medical Center, Nashville, Tennessee.

Funding

Leadership and Operations Center (LOC), AIDS Clinical Trials Group (ACTG); LOC 1/UM1AI068636 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph J Eron, RAJESH T GANDHI · 2011 to 2026
$1073.1M
Statistical and Data Management Center (SDMC), AIDS Clinical Trials Group (ACTG)UM1AI068634 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI Marlene Ann Cooper, Michael David Hughes · 2011 to 2026
$246.6M
Validation, CLIA and Qualification (VQC): Enhancing the RS ratio as a tool for AIDS Clinical Trial Group (ACTG) tuberculosis trialsUM1AI106701 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Grace M Aldrovandi · 2014 to 2026
$116.8M
Statistical and Data Management Center for the AIDS Clinical Trials GroupU01AI068634 · NIAID · HARVARD SCHOOL OF PUBLIC HEALTH · PI HUGHES, MICHAEL DAVID · 2006 to 2010
$71.9M
Vaccine Response and Immunotherapeutics SWGP30AI094189 · NIAID · JOHNS HOPKINS UNIVERSITY · PI Richard E. Chaisson · 2012 to 2026
$67.0M
LC - IMPAACT Leadership GroupUM1AI106716 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Grace M Aldrovandi · 2014 to 2026
$47.2M
Intramural CDC HHS CC999999NIAID NIH HHS P30 AI094189NIAID NIH HHS U01 AI068634NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI106701NIAID NIH HHS UM1 AI106716
6 · The paper itself

Abstract

rationaleData are limited regarding the safety of 12-dose once-weekly isoniazid (H, 900 mg) plus rifapentine (P, 900 mg) (3HP) for latent infection treatment during pregnancy.

objectivesTo assess safety and pregnancy outcomes among pregnant women who were inadvertently exposed to study medications in two latent tuberculosis infection trials (PREVENT TB or iAdhere) evaluating 3HP and 9 months of daily isoniazid (H, 300 mg) (9H).

methodsData from reproductive-age (15-51 yr) women who received one or more study dose of 3HP or 9H in either trial were analyzed. Drug exposure during pregnancy occurred if the estimated date of conception was on or before the last dose date.

resultsOf 126 pregnancies (125 participants) that occurred during treatment or follow-up, 87 were exposed to study drugs. Among these, fetal loss was reported for 4/31 (13%) and 8/56 (14%), 3HP and 9H, respectively (difference, 13% - 14% = -1%; 95% confidence interval = -17% to +18%) and congenital anomalies in 0/20 and 2/41 (5%) live births, 3HP and 9H, respectively (difference, 0% - 5% = -5%; 95% confidence interval = -18% to +16%). All fetal losses occurred in pregnancies of less than 20 weeks. Of the total 126 pregnancies, fetal loss was reported in 8/54 (15%) and 9/72 (13%), 3HP and 9H, respectively; and congenital anomalies in 1/37 (3%) and 2/56 (4%) live births, 3HP and 9H, respectively. The overall proportion of fetal loss (17/126 [13%]) and anomalies (3/93 [3%]) were similar to those estimated for the United States, 17% and 3%, respectively.

conclusionsAmong reported pregnancies in these two latent tuberculosis infection trials, there was no unexpected fetal loss or congenital anomalies. These data offer some preliminary reassurance to clinicians and patients in circumstances when these drugs and regimens are the best option in pregnancy or in women of child-bearing potential. This work used the identifying trial registration numbers NCT00023452 and NCT01582711, corresponding to the primary clinical trials PREVENT TB and iAdhere (Tuberculosis Trials Consortium Study 26 and 33).

Indexed as

AdolescentAdultAntitubercular AgentsDose-Response Relationship, DrugDrug Administration ScheduleDrug Therapy, CombinationFemaleHumansInfant, NewbornIsoniazidLatent TuberculosisMiddle AgedPregnancyPregnancy Complications, InfectiousPregnancy OutcomeRifampinAntitubercular AgentsIsoniazidRifampinrifapentinelatent tuberculosis infection treatmentpregnancy outcomessafety assessment

Identifiers

PMID29393655
PMCPMC6624829

What OpenQuestion holds

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Registered trials

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.