Evidence map›Paper›PMID 38640958›Full record

Trial reportThe Journal of infectious diseases2024

Assessment for Antibodies to Rifapentine and Isoniazid in Persons Developing Flu-Like Reactions During Treatment of Latent Tuberculosis Infection.

Ruth N Moro, Carolina Mehaffy, Prithwiraj De, Elizabeth Phillips, Andrey S Borisov, Timothy R Sterling, Karen M Dobos

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled TrialClinical Trial, Phase III
In one paragraph

Trial report in The Journal of infectious diseases, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00023452 (TBTC Study 26), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
0.4field-weighted citation impact, top 42% 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
3 · Its place in the literature

Who cites it

0 citing papers in PubMed, 1 citations in OpenAlex.

No citing paper in PubMed yet.

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

7 authors at 3 institutions in 1 country.

Ruth N MoroDivision of HIV Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.ORCID 0000-0002-8283-1304
Carolina MehaffyDepartment of Microbiology, Immunology, and Pathology, Colorado State University, Fort Collins, Colorado, USA.
Prithwiraj DeDepartment of Microbiology, Immunology, and Pathology, Colorado State University, Fort Collins, Colorado, USA.
Elizabeth PhillipsDepartment of Medicine, Division of Infectious Diseases, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.
Andrey S BorisovDivision of HIV Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
Timothy R SterlingDepartment of Medicine, Division of Infectious Diseases, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.
Karen M DobosDepartment of Microbiology, Immunology, and Pathology, Colorado State University, Fort Collins, Colorado, USA.
Colorado State University · USCenters for Disease Control and Prevention · USVanderbilt University · US

Funding

Intramural CDC HHS CC999999
6 · The paper itself

Abstract

backgroundFlu-like reactions can occur after exposure to rifampin, rifapentine, or isoniazid. Prior studies have reported the presence of antibodies to rifampin, but associations with underlying pathogenesis are unclear.

methodsWe evaluated PREVENT TB study participants who received weekly isoniazid plus rifapentine for 3 months (3HP) or daily isoniazid for 9 months (9H) as treatment for Mycobacterium tuberculosis infection. Flu-like reaction was defined as a grade ≥2 of any of flu-like symptoms. Controls (3HP or 9H) did not report flu-like reactions. We developed a competitive enzyme-linked immunosorbent assays (ELISA) to detect antibodies against rifapentine, isoniazid, rifampin, and rifapentine metabolite.

resultsAmong 128 participants, 69 received 3HP (22 with flu-like reactions; 47 controls) and 59 received 9H (12 with flu-like reactions; 47 controls). In participants receiving 3HP, anti-rifapentine IgG was identified in 2 of 22 (9%) participants with flu-like reactions and 6 of 47 (13%) controls (P = .7), anti-isoniazid IgG in 2 of 22 (9%) participants with flu-like reactions and 4 of 47 (9%) controls (P = .9). Among participants receiving 9H, IgG and IgM anti-isoniazid antibodies were each present in 4 of 47 (9%) controls, but none among participants with flu-like reactions; anti-rifapentine IgG antibodies were not present in any participants with flu-like reactions or controls.

conclusionsWe detected anti-rifapentine, anti-isoniazid, and anti-rifapentine metabolite antibodies, but the proportions of participants with antibodies were low, and did not differ between participants with flu-like reactions and those without such reactions. This suggests that flu-like reactions associated with 3HP and 9H were not antibody mediated. CLINICAL TRIALS REGISTRATION: NCT00023452.

Indexed as

Antitubercular AgentsIsoniazidLatent TuberculosisRifampinAdolescentAdultAgedAntibodiesEnzyme-Linked Immunosorbent AssayFemaleHumansInfluenza, HumanMaleMiddle AgedYoung AdultAntibodiesAntitubercular AgentsIsoniazidRifampinrifapentineantibodiesisoniazidlatent tuberculosisM. tuberculosisrifapentine

Identifiers

PMID38640958
PMCPMC11489317
OpenAlexW4394964154

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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.