Evidence map›Paper›PMID 25904367›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2015

Flu-like and Other Systemic Drug Reactions Among Persons Receiving Weekly Rifapentine Plus Isoniazid or Daily Isoniazid for Treatment of Latent Tuberculosis Infection in the PREVENT Tuberculosis Study.

Timothy R Sterling, Ruth N Moro, Andrey S Borisov, Elizabeth Phillips, Gillian Shepherd, Newton Franklin Adkinson, Stephen Weis, Christine Ho, Margarita Elsa Villarino, Tuberculosis Trials Consortium

4 registry-linked trialsOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 53 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
53citing papers in PubMed, 6 pooled it
6.2field-weighted citation impact, top 3% 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.

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
NCT02980016 phase3completednot on this mapstarted 2016, after this paper: background citation

A Randomised, Pragmatic, Open-Label Trial To Evaluate The Effect Of Three Months Of High Dose Rifapentine Plus Isoniazid Administered As A Single Round Or Given Annually In HIV-Positive Individuals

TypeinterventionalSponsorThe Aurum Institute NPCRan2016 to 2019Enrolled4,027ConditionsTuberculosis, HIVArmsrifapentine + isoniazid, Isoniazid
NCT03783728 withdrawnnot on this mapstarted 2019, after this paper: background citation

Efficacy of Risk-Targeted Video Based Directly on Observed Therapy for Latent TB

TypeobservationalSponsorSt. Louis UniversityRan2019 to 2020Enrolled0ConditionsLatent TuberculosisArmsRifapentine 600 mg orally, Isoniazid 900 mg orally, Pyridoxine 50 mg orally
3 · Its place in the literature

Who cites it

53 citing papers in PubMed, 6 syntheses or guidelines pooled it, 104 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Guidelines for the Treatment of Latent Tuberculosis Infection: Recommendations from the National Tuberculosis Controllers Association and CDC, 2020.MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports · 2020
    Pooled it
  4. Pooled it
  5. Guideline
  6. Pooled it
  7. Three Months of Weekly Rifapentine and Isoniazid Versus Four Months of Daily Rifampicin for Tuberculosis Infection: A Randomized Controlled Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026
    Trial
  8. Trial
  9. Trial
  10. Trial
  11. Cytokine-Mediated Systemic Adverse Drug Reactions in a Drug-Drug Interaction Study of Dolutegravir With Once-Weekly Isoniazid and Rifapentine.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2018
    Trial
  12. Trial
  13. Trial
  14. Trial
  15. Article
  16. Article
  17. Tuberculosis: An Update for the Clinician.Respirology (Carlton, Vic.) · 2025
    Review
  18. Review
  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

10 authors at 6 institutions in 2 countries.

Timothy R SterlingVanderbilt University School of Medicine, Nashville, Tennessee.
Ruth N MoroCenters for Disease Control and Prevention CDC Foundation, Research Collaboration, Atlanta, Georgia.
Andrey S BorisovCenters for Disease Control and Prevention.
Elizabeth PhillipsVanderbilt University School of Medicine, Nashville, Tennessee Institute for Immunology and Infectious Diseases, Murdoch University, Perth, Australia.
Gillian ShepherdNew York-Presbyterian Hospital/Weill Cornell Medical Center, New York.
Newton Franklin AdkinsonJohns Hopkins University School of Medicine, Baltimore, Maryland.
Stephen WeisUniversity of North Texas Health Science Center at Ft. Worth.
Christine HoCenters for Disease Control and Prevention.
Margarita Elsa VillarinoCenters for Disease Control and Prevention.
Tuberculosis Trials Consortium
CDC Foundation · USJohns Hopkins Medicine · USMurdoch University · AUNewYork–Presbyterian Hospital · USUniversity of North Texas · USVanderbilt University · US

Funding

Vaccine Response and Immunotherapeutics SWGP30AI094189 · NIAID · JOHNS HOPKINS UNIVERSITY · PI Richard E. Chaisson · 2012 to 2026
$67.0M
NIAID NIH HHS P30 AI094189
6 · The paper itself

Abstract

backgroundWeekly rifapentine plus isoniazid for 3 months (3HP) is as effective as daily isoniazid for 9 months (9H) for latent tuberculosis infection in high-risk persons, but there have been reports of possible flu-like syndrome.

methodsWe identified clinically significant systemic drug reactions (SDR) and evaluated risk factors in patients who did not complete treatment in the PREVENT Tuberculosis study.

resultsAmong 7552 persons who received ≥ 1 dose of study drug, 153 had a SDR: 138/3893 (3.5%) with 3HP vs 15/3659 (0.4%) with 9H (P < .001). In the 3HP arm, 87 (63%) had flu-like syndrome and 23 (17%) had cutaneous reactions; 13/3893 (0.3%) had severe reactions (6 were hypotensive) and 6 reported syncope. Symptoms occurred after a median of 3 doses, and 4 hours after the dose; median time to resolution was 24 hours. There were no deaths. In multivariate logistic regression analysis, factors independently associated with SDR included receipt of 3HP (adjusted odds ratio [aOR] 9.4; 95% confidence interval [CI], 5.5, 16.2), white non-Hispanic race/ethnicity (aOR 3.3; 95% CI, 2.3, 4.7), female sex (aOR 2.0; 95% CI, 1.4, 2.9), age ≥ 35 years (aOR 2.0; 95% CI, 1.4, 2.9), and lower body mass index (body mass index [BMI]; P = .009). In a separate multivariate analysis among persons who received 3HP, severe SDR were associated with white non-Hispanic race/ethnicity (aOR 5.4; 95% CI, 1.8, 16.3), and receipt of concomitant non-study medications (aOR 5.9; 95% CI, 1.3, 27.1).

conclusionsSDR were more common with 3HP, and mostly flu-like. Persons of white race, female sex, older age, and lower BMI were at increased risk. Severe reactions were rare and associated with 3HP, concomitant medication, and white race. The underlying mechanism is unclear. CLINICAL TRIALS REGISTRATION: NCT00023452.

Indexed as

AdolescentAdultAntitubercular AgentsDrug-Related Side Effects and Adverse ReactionsFemaleHumansIsoniazidLatent TuberculosisMaleMiddle AgedProspective StudiesRespiratory Tract DiseasesRifampinAntitubercular AgentsIsoniazidRifampinrifapentineadverse drug reactionflu-like syndromeisoniazidrifapentinetreatment of latent M. tuberculosis infection

Identifiers

PMID25904367
PMCPMC4560029
OpenAlexW2106892252

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.