Evidence map›Paper›PMID 24135768›Full record

Trial reportChest2014

Effect of isoniazid therapy for latent TB infection on QuantiFERON-TB gold in-tube responses in adults with positive tuberculin skin test results in a high TB incidence area: a controlled study.

John L Johnson, Hendrik Geldenhuys, Bonnie A Thiel, Asma Toefy, Sara Suliman, Bernadette Pienaar, Phalkun Chheng, Thomas Scriba, W Henry Boom, Willem Hanekom and 1 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Chest, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01119521 (Phase I Study of Whether Preclearance of Latent M. Tuberculosis), which is not on this map. Cited by 24 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 1 pooled it
2.1field-weighted citation impact, top 13% 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.

NCT01119521 phase1completednot on this map

Phase I Study of Whether Preclearance of Latent M. Tuberculosis (MTB) Infection With Isoniazid (INH) Enhances Specific Immune Responses to MTB Following Subsequent BCG Revaccination in Healthy, HIV-Uninfected, Tuberculin Skin Test Positive Adults

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2010 to 2013Enrolled82ConditionsTuberculosisArmsBCG strain Danish, Isoniazid
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 1 synthesis or guideline pooled it, 35 citations in OpenAlex.

  1. Pooled it
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  7. Article
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  9. Granulomatous Cheilitis or Tuberculid?Antibiotics (Basel, Switzerland) · 2022
    Article
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  11. Article
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  13. Tuberculosis Infection in Women of Reproductive Age: A Cross-sectional Study at Antenatal Care Clinics in an Ethiopian City.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2021
    Article
  14. Clinical application of QuantiFERON-TB Gold in-tube in the diagnosis and treatment of tuberculosis.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2020
    Review
  15. Review
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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

11 authors at 5 institutions in 2 countries.

John L Johnson
Hendrik Geldenhuys
Bonnie A Thiel
Asma Toefy
Sara Suliman
Bernadette Pienaar
Phalkun Chheng
Thomas Scriba
W Henry Boom
Willem Hanekom
Mark Hatherill
Case Western Reserve University · USSouth African Tuberculosis Vaccine Initiative · ZAUniversity Hospitals Case Medical Center · USUniversity Hospitals of Cleveland · USUniversity of Cape Town · ZA

Funding

Tuberculosis Prevention Research Unit /TBRU/-266095383N01AI095383 · NIAID · CASE WESTERN RESERVE UNIVERSITY · 2000 to 2005
$5.6M
NIAID NIH HHS HHSN266200700022C/N01-AI-70022NIAID NIH HHS N01 AI070022NIAID NIH HHS N01 AI095383NIAID NIH HHS N01-AI-95383
6 · The paper itself

Abstract

backgroundT-cell interferon-γ release assays (IGRAs) are used in the diagnosis of Mycobacterium tuberculosis infection and could be useful biomarkers of response to treatment of latent TB infection for clinical trials, infection control units, and TB programs.

methodsThis investigation was a prospective, controlled substudy of IGRA responses in 82 healthy South African adults with HIV seronegative and positive tuberculin skin test results randomly assigned to treatment with 6 months of daily isoniazid preventive therapy (IPT) or observation before Bacillus Calmette-Guérin revaccination in a clinical trial. QuantiFERON-TB Gold In-Tube (QFT-GIT) assay was used to measure interferon-γ (IFN-γ) response to mycobacterial antigens at baseline and after IPT or observation.

resultsIFN-γ levels declined between baseline and the end of IPT (signed rank test P≤.0001) and between baseline and a similar period of observation without IPT (signed rank test P=.03). The rate of decrease in IFN-γ responses over time did not differ between the groups (Mann-Whitney-Wilcoxon test P=.31). QFT-GIT test results in two subjects (5%) in the IPT group and two subjects (5%) in the observation group reverted from positive to negative during follow-up. No significant difference was found between the groups with respect to baseline positivity or the proportion of patients whose tests reverted to negative.

conclusionsIPT had no effect on changes in QFT-GIT readouts during short-term follow-up of adults with positive tuberculin skin tests in a high TB incidence setting. QFT-GIT is unlikely to be a useful biomarker of response to treatment of latent TB infection. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT01119521; URL: www.clinicaltrials.gov.

Indexed as

AdolescentAdultAntitubercular AgentsFemaleFollow-Up StudiesHumansIncidenceInterferon-gammaInterferon-gamma Release TestsIsoniazidMaleMycobacterium tuberculosisProspective StudiesSouth AfricaTime FactorsTreatment OutcomeAntitubercular AgentsInterferon-gammaIsoniazid

Identifiers

PMID24135768
PMCPMC3941252
OpenAlexW2142958906

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.