Evidence map›Paper›PMID 39802795›Full record

ArticlemedRxiv : the preprint server for health sciences2024

PET/CT guided tuberculosis treatment shortening: a randomized trial.

Stephanus T Malherbe, Ray Y Chen, Xiang Yu, Bronwyn Smith, Xin Liu, Jingcai Gao, Andreas H Diacon, Rodney Dawson, Michele Tameris, Hong Zhu and 45 more

Abstract readPreprint
PubMed Full text at PMC Publisher
In one paragraph

Article in medRxiv : the preprint server for health sciences, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 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

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. 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

55 authors.

Stephanus T MalherbeDST-NRF Centre of Excellence for Biomedical Tuberculosis Research, South African Medical Research Council Centre for Tuberculosis Research, Division of Immunology, Department of Biomedical Sciences, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.
Ray Y ChenTuberculosis Research Section, Laboratory of Clinical Immunology and Microbiology, Division of Intramural Research, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, MD, USA.
Xiang YuTuberculosis Research Section, Laboratory of Clinical Immunology and Microbiology, Division of Intramural Research, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, MD, USA.
Bronwyn SmithDST-NRF Centre of Excellence for Biomedical Tuberculosis Research, South African Medical Research Council Centre for Tuberculosis Research, Division of Immunology, Department of Biomedical Sciences, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.
Xin LiuHenan Provincial Chest Hospital, Zhengzhou, Henan, China.
Jingcai GaoSino-US Tuberculosis Collaborative Research Program, Zhengzhou, Henan, China.
Andreas H DiaconTASK, Cape Town, South Africa.
Rodney DawsonDivision of Pulmonology, Department of Medicine, University of Cape Town Lung Institute, Centre for TB Research Innovation, Observatory 7923, Republic of South Africa.
Michele TamerisSouth African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine, Department of Pathology, University of Cape Town, Observatory 7923, Republic of South Africa.
Hong ZhuSino-US Tuberculosis Collaborative Research Program, Zhengzhou, Henan, China.
Yahong QuKaifeng City Institute of Tuberculosis Prevention and Control, Kaifeng, Henan, China.
Hongjian JinXinmi Center for Disease Control and Prevention, Xinmi, Henan, China.
Shouguo PanZhongmu County Health and Epidemic Prevention Station, Zhongmu, Henan, China.
Lori E DoddClinical Clinical Trials Research and Statistics Branch, Office of Biostatistics Research, Division of Clinical Research, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, MD, USA.
Jing WangClinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick, MD, USA.
Lisa C GoldfederTuberculosis Research Section, Laboratory of Clinical Immunology and Microbiology, Division of Intramural Research, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, MD, USA.
Ying CaiTuberculosis Research Section, Laboratory of Clinical Immunology and Microbiology, Division of Intramural Research, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, MD, USA.
Kriti AroraTuberculosis Research Section, Laboratory of Clinical Immunology and Microbiology, Division of Intramural Research, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, MD, USA.
Joel VincentTuberculosis Research Section, Laboratory of Clinical Immunology and Microbiology, Division of Intramural Research, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, MD, USA.
Kim NarunskyUniversity of Cape Town Lung Institute (Pty) Ltd, Mowbray, Cape Town, 7700, Republic of South Africa.
Keboile SeroleCentre for Infectious Diseases Research in Africa, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Observatory 7925, Republic of South Africa.
Rene T GoliathCentre for Infectious Diseases Research in Africa, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Observatory 7925, Republic of South Africa.
Laylah Da CostaCentre for Infectious Diseases Research in Africa, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Observatory 7925, Republic of South Africa.
Arshad TaliepCentre for Infectious Diseases Research in Africa, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Observatory 7925, Republic of South Africa.
Saalikha AzizCentre for Infectious Diseases Research in Africa, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Observatory 7925, Republic of South Africa.
Remy DaroowalaCentre for Infectious Diseases Research in Africa, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Observatory 7925, Republic of South Africa.
Friedrich ThienemannCentre for Infectious Diseases Research in Africa, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Observatory 7925, Republic of South Africa.
Sandra MukasaCentre for Infectious Diseases Research in Africa, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Observatory 7925, Republic of South Africa.
Richard CourtCentre for Infectious Diseases Research in Africa, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Observatory 7925, Republic of South Africa.
Bianca SossenCentre for Infectious Diseases Research in Africa, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Observatory 7925, Republic of South Africa.
Petri AhlersDST-NRF Centre of Excellence for Biomedical Tuberculosis Research, South African Medical Research Council Centre for Tuberculosis Research, Division of Immunology, Department of Biomedical Sciences, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.
Simon C MendelsohnSouth African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine, Department of Pathology, University of Cape Town, Observatory 7923, Republic of South Africa.ORCID 0000-0002-4054-2766
Lisa WhiteUniversity of Cape Town Lung Institute (Pty) Ltd, Mowbray, Cape Town, 7700, Republic of South Africa.
Aurélie GouelClinical Clinical Trials Research and Statistics Branch, Office of Biostatistics Research, Division of Clinical Research, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, MD, USA.
Chuen-Yen LauHIV Dynamics and Replication Program, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
Samy HassanDepartment of Internal Medicine, University Hospital Zurich, University of Zurich, Zurich, Switzerland.
Lili LiangHenan Provincial Chest Hospital, Zhengzhou, Henan, China.
Hongfei DuanBeijing Chest Hospital, Beijing, China.
Gita K MoghaddamDepartment of Clinical Neurosciences, University of Cambridge, UK.
Praveen ParipatiOffice of Cyber Infrastructure and Computational Biology, NIAID, NIH, Bethesda, MD, USA.
Saher LahouarOffice of Cyber Infrastructure and Computational Biology, NIAID, NIH, Bethesda, MD, USA.
Michael HarrisOffice of Cyber Infrastructure and Computational Biology, NIAID, NIH, Bethesda, MD, USA.
Kurt WollenbergOffice of Cyber Infrastructure and Computational Biology, NIAID, NIH, Bethesda, MD, USA.
Brendan JeffreyOffice of Cyber Infrastructure and Computational Biology, NIAID, NIH, Bethesda, MD, USA.
Mike TartakovskyOffice of Cyber Infrastructure and Computational Biology, NIAID, NIH, Bethesda, MD, USA.
Alex RosenthalOffice of Cyber Infrastructure and Computational Biology, NIAID, NIH, Bethesda, MD, USA.
Michael DuvenhageResearch Data and Communication Technologies, Inc., Garrett Park, MD, USA.
Derek T ArmstrongDepartment of Pathology, Johns Hopkins University, Baltimore, MD, USA.
Taeksun SongCentre for Infectious Diseases Research in Africa, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Observatory 7925, Republic of South Africa.
Jill WinterCatalysis Foundation for Health, San Ramon, CA, USA.
Qian GaoSchool of Basic Medical Science, Shanghai Medical College, Fudan University, Shanghai, China.
Laura E ViaTuberculosis Research Section, Laboratory of Clinical Immunology and Microbiology, Division of Intramural Research, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, MD, USA.
Robert J WilkinsonCentre for Infectious Diseases Research in Africa, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Observatory 7925, Republic of South Africa.
Gerhard WalzlDST-NRF Centre of Excellence for Biomedical Tuberculosis Research, South African Medical Research Council Centre for Tuberculosis Research, Division of Immunology, Department of Biomedical Sciences, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.
Clifton E BarryTuberculosis Research Section, Laboratory of Clinical Immunology and Microbiology, Division of Intramural Research, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, MD, USA.

Funding

Wellcome Trust CC2112
6 · The paper itself

Abstract

Six months of chemotherapy using current agents is standard of care for pulmonary, drug-sensitive tuberculosis (TB), even though some are believed to be cured more rapidly and others require longer therapy. Understanding what factors determine the length of treatment required for durable cure in individual patients would allow individualization of treatment durations, provide better clinical tools to determine the of appropriate duration of new regimens, as well as reduce the cost of large Phase III studies to determine the optimal combinations to use in TB control programs. We conducted a randomized clinical trial in South Africa and China that recruited 704 participants with newly diagnosed, drug-sensitive pulmonary tuberculosis and stratified them based on radiographic disease characteristics as assessed by FDG PET/CT scan readers. Participants with less extensive disease (N=273) were randomly assigned to complete therapy after four months or continue receiving treatment for six months. Amongst participants who received four months of therapy, 17 of 141 (12.1%) experienced unfavorable outcomes compared to only 2 of 132 (1.5%) who completed six months of treatment (treatment success 98.4% in B, 86.7% in C (difference -11.7%, 95% CI, -18.2%, -5.3%)). In the non-randomized arm that included participants with more extensive disease, only 8 of 248 (3.2%) experienced unfavorable outcomes. Total cavity volume and total lesion glycolysis at week 16 were significantly associated with risk of unfavorable outcome in the randomized participants. Based on PET/CT scans at TB recurrence, bacteriological relapses (confirmed by whole genome sequencing) predominantly occurred in the same active cavities originally present at baseline. Automated segmentation of the serial PET/CT scans was later performed, and machine-learning was used to classify participants according to their likelihood of relapse, allowing the development of predictive models with good performance based on CT, PET, microbiological and clinical characteristics. These results open the possibility for more efficient studies of future TB treatment regimens.

Identifiers

PMID39802795
PMCPMC11722446

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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.