Evidence map›Paper›PMID 26022314›Full record

Trial reportTuberculosis (Edinburgh, Scotland)2015

Serum biomarkers of treatment response within a randomized clinical trial for pulmonary tuberculosis.

A Jayakumar, E Vittinghoff, M R Segal, W R MacKenzie, J L Johnson, P Gitta, J Saukkonen, J Anderson, M Weiner, M Engle and 4 more

Abstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Tuberculosis (Edinburgh, Scotland), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 3 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.

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

24 citing papers in PubMed, 3 syntheses or guidelines pooled it.

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  17. Enhanced Anti-Vaccines · 2018
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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

14 authors.

A JayakumarUniversity of California, San Francisco, 1001 Potrero Ave, San Francisco, CA 94110, USA. Electronic address: archana.jayakumar@ucsf.edu.
E VittinghoffUniversity of California, San Francisco, 550 16th Street, 2nd Floor, San Francisco, CA 94158, USA. Electronic address: eric.vittinghoff@ucsf.edu.
M R SegalUniversity of California, San Francisco, 550 16th Street, 2nd Floor, San Francisco, CA 94158, USA. Electronic address: mark.segal@ucsf.edu.
W R MacKenzieDivision of Tuberculosis Elimination, Centers for Disease Control & Prevention, 1600 Clifton Rd., NE MS E10, Atlanta, GA 30329, USA. Electronic address: wrm0@cdc.gov.
J L JohnsonCase Western Reserve University, University Hospitals Case Medical Center, 10900 Euclid Ave., Cleveland, OH 44106, USA; Uganda-Case Western Reserve University Research Collaboration, P.O. Box 663, Kampala, Uganda. Electronic address: jlj@case.edu.
P GittaUganda-Case Western Reserve University Research Collaboration, P.O. Box 663, Kampala, Uganda. Electronic address: pgitta@mucwru.or.ug.
J SaukkonenBoston University School of Medicine, 150 South Huntington Avenue, Jamaica Plain, MA 02130, USA. Electronic address: jussi.saukkonen@va.gov.
J AndersonUniversity of California, San Francisco, 1001 Potrero Ave, San Francisco, CA 94110, USA. Electronic address: jilliananderson@gmail.com.
M WeinerUniversity of Texas Health Science Center, 7703 Floyd Curl., San Antonio, TX 78229, USA. Electronic address: weiner@uthscsa.edu.
M EngleUniversity of Texas Health Science Center, 7703 Floyd Curl., San Antonio, TX 78229, USA. Electronic address: Englem2@uthscsa.edu.
C YoonUniversity of California, San Francisco, 1001 Potrero Ave, San Francisco, CA 94110, USA. Electronic address: christina.yoon@ucsf.edu.
M Kato-MaedaUniversity of California, San Francisco, 1001 Potrero Ave, San Francisco, CA 94110, USA. Electronic address: midori.kato-maeda@ucsf.edu.
P NahidUniversity of California, San Francisco, 1001 Potrero Ave, San Francisco, CA 94110, USA. Electronic address: pnahid@ucsf.edu.
Tuberculosis Trials Consortium

Funding

TB Surrogate Markers for Assessing Reponse to Treatment (TB SMART Study)R01AI104589 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI NAHID, PAYAM, SIGAL, GEORGE B · 2013 to 2017
$6.2M
Evaluation of novel tuberculosis screening strategies for people living with HIVK23AI114363 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI YOON, CHRISTINA · 2014 to 2018
$943k
NHLBI NIH HHS L30 HL110240NIAID NIH HHS 1R01AI104589NIAID NIH HHS K23 AI114363NIAID NIH HHS R01 AI104589
6 · The paper itself

Abstract

rationaleBiomarkers for monitoring response to anti-tuberculosis treatment are needed. We explored immune markers previously published as having predictive capability for 8 week culture status in 39 adults enrolled in a clinical trial in Kampala, Uganda.

methodsWe consecutively selected 20 HIV-negative pulmonary TB subjects with positive cultures, and 19 subjects with negative cultures at the end of intensive phase therapy. At baseline and after 8 weeks, serum was assayed for nine cytokines and soluble cytokine receptors using multiplexed platforms or ELISA. We evaluated their association with week 8 culture status first using single-variable logistic models, then using cross-validated estimates of the C-statistic, a measure of discrimination, of candidate models including 2 or 3 analytes in addition to age.

resultsAll but one analyte decreased from baseline to week 8 (all p < 0.01). Individual biomarkers were not associated with 8 week culture status. Logistic models including increasing age, higher baseline soluble tumor necrosis factor receptor alpha 1 (sTNF-R1), and higher week 8 C-reactive protein (CRP) concentration classified subjects by culture status with up to 85% accuracy and acceptable discrimination (cross-validated C-statistic 0.76) and calibration (Hosmer-Lemeshow P > 0.2).

conclusionExploratory post-hoc models including sTNF-R1, CRP, and age, classified 8 week culture status with promising accuracy.

Indexed as

AdultAge FactorsAntitubercular AgentsBiomarkersC-Reactive ProteinCytokinesEnzyme-Linked Immunosorbent AssayFemaleHost-Pathogen InteractionsHumansLogistic ModelsMaleMultivariate AnalysisMycobacterium tuberculosisPredictive Value of TestsReceptors, CytokineAntitubercular AgentsBiomarkersC-Reactive ProteinCytokinesReceptors, CytokineReceptors, Tumor Necrosis Factor, Type ITNFRSF1A protein, humanBiomarkersPulmonaryTreatment responseTuberculosis

Identifiers

PMID26022314
PMCPMC4521594

What OpenQuestion holds

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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.