Rapid and Accurate Diagnosis of Pediatric Tuberculosis Disease: A Diagnostic Accuracy Study for Pediatric Tuberculosis.
Journal
The Pediatric infectious disease journal
ISSN: 1532-0987
Titre abrégé: Pediatr Infect Dis J
Pays: United States
ID NLM: 8701858
Informations de publication
Date de publication:
01 05 2023
01 05 2023
Historique:
medline:
14
4
2023
pubmed:
1
3
2023
entrez:
28
2
2023
Statut:
ppublish
Résumé
An estimated 1.2 million children develop tuberculosis (TB) every year with 240,000 dying because of missed diagnosis. Existing tools suffer from lack of accuracy and are often unavailable. Here, we describe the scientific and clinical methodology applied in RaPaed-TB, a diagnostic accuracy study. This prospective diagnostic accuracy study evaluating several candidate tests for TB was set out to recruit 1000 children <15 years with presumptive TB in 5 countries (Malawi, Mozambique, South Africa, Tanzania, India). Assessments at baseline included documentation of TB signs and symptoms, TB history, radiography, tuberculin skin test, HIV testing and spirometry. Respiratory samples for reference standard testing (culture, Xpert Ultra) included sputum (induced/spontaneous) or gastric aspirate, and nasopharyngeal aspirate (if <5 years). For novel tests, blood, urine and stool were collected. All participants were followed up at months 1 and 3, and month 6 if on TB treatment or unwell. The primary endpoint followed NIH-consensus statements on categorization of TB disease status for each participant. The study was approved by the sponsor's and all relevant local ethics committees. As a diagnostic accuracy study for a disease with an imperfect reference standard, Rapid and Accurate Diagnosis of Pediatric Tuberculosis Disease (RaPaed-TB) was designed following a rigorous and complex methodology. This allows for the determination of diagnostic accuracy of novel assays and combination of testing strategies for optimal care for children, including high-risk groups (ie, very young, malnourished, children living with HIV). Being one of the largest of its kind, RaPaed-TB will inform the development of improved diagnostic approaches to increase case detection in pediatric TB.
Identifiants
pubmed: 36854097
doi: 10.1097/INF.0000000000003853
pii: 00006454-202305000-00002
pmc: PMC10097493
doi:
Banques de données
ClinicalTrials.gov
['NCT03734172']
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
353-360Informations de copyright
Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc.
Déclaration de conflit d'intérêts
The authors have no conflicts of interest to disclose.
Références
World Health Organisation. Global tuberculosis report. 2021.
Dodd PJ, Yuen CM, Sismanidis C, et al. The global burden of tuberculosis mortality in children: a mathematical modelling study. Lancet Glob Heal. 2017;5:e898–e906.
World Health Organisation. Roadmap Towards Ending TB in Children and Adolescents. Geneva; 2018.
Perez-Velez CM, Marais BJ. Tuberculosis in children. N Engl J Med. 2012;367:348–361.
Oliwa JN, Karumbi JM, Marais BJ, et al. Tuberculosis as a cause or comorbidity of childhood pneumonia in tuberculosis-endemic areas: a systematic review. Lancet Respir Med. 2015;3:235–243.
Gunasekera KS, Walters E, van der Zalm MM, et al. Development of a treatment-decision algorithm for human immunodeficiency virus-uninfected children evaluated for pulmonary tuberculosis. Clin Infect Dis. 2021;73:e904–e912.
Marcy O, Borand L, Ung V, et al. A treatment-decision score for HIV-infected children with suspected tuberculosis. Pediatrics. 2019;144:2018–2065.
Tebruegge M, Ritz N, Curtis N, et al. Diagnostic tests for childhood tuberculosis. Pediatr Infect Dis J. 2015;34:101410149–101411019.
Detjen AK, DiNardo AR, Leyden J, et al. Xpert MTB/RIF assay for the diagnosis of pulmonary tuberculosis in children: a systematic review and meta-analysis. Lancet Respir Med. 2015;3:451–461.
Marais BJ, Gie RP, Schaaf HS, et al. Childhood pulmonary tuberculosis: old wisdom and new challenges. Am J Respir Crit Care Med. 2006;173:1078–1090.
Marais BJ, Gie RP, Schaaf HS, et al. The natural history of childhood intra-thoracic tuberculosis: a critical review of literature from the pre-chemotherapy era. Int J Tuberc Lung Dis. 2004;8:392–402.
World Health Organization. High-priority target product profiles for new tuberculosis diagnostics: report of a consensus meeting. 2014:1–96.
Treatment Action Group. The tuberculosis diagnostics pipeline report: advancing the next generation of tools. 2020.
Drain PK, Gardiner J, Hannah H, et al. Guidance for studies evaluating the accuracy of biomarker-based nonsputum tests to diagnose tuberculosis. J Infect Dis. 2019;220 220 Suppl 3:S108–S115.
Nathavitharana RR, Yoon C, Macpherson P, et al. Guidance for studies evaluating the accuracy of tuberculosis triage tests. J Infect Dis. 2019;220 220 Suppl 3:S116–S125.
Zar HJ, Hanslo D, Apolles P, et al. Induced sputum versus gastric lavage for microbiological confirmation of pulmonary tuberculosis in infants and young children: a prospective study. Lancet (London, England). 2005;365:130–134.
Zar HJ, Tannenbaum E, Hanslo D, et al. Sputum induction as a diagnostic tool for community-acquired pneumonia in infants and young children from a high HIV prevalence area. Pediatr Pulmonol. 2003;36:58–62.
Howie SRC. Blood sample volumes in child health research: review of safe limits. Bull World Health Organ. 2011;89:46–53.
Grønningen E, Nanyaro M, Sviland L, et al. MPT64 antigen detection test improves diagnosis of pediatric extrapulmonary tuberculosis in Mbeya, Tanzania. Sci Rep. 2021;11:17540.
Ahmed MIM, Ntinginya NE, Kibiki G, et al. Phenotypic changes on Mycobacterium tuberculosis-specific CD4 T Cells as surrogate markers for tuberculosis treatment efficacy. Front Immunol. 2018;9:2247.
Portevin D, Moukambi F, Clowes P, et al. Assessment of the novel T-cell activation marker-tuberculosis assay for diagnosis of active tuberculosis in children: a prospective proof-of-concept study. Lancet Infect Dis. 2014;14:931–938.
Sweeney TE, Braviak L, Tato CM, et al. Genome-wide expression for diagnosis of pulmonary tuberculosis: a multicohort analysis. Lancet Respir Med. 2016;4:213–224.
Sutherland JS, van der Spuy G, Gindeh A, et al. Diagnostic accuracy of the Cepheid 3-gene host response fingerstick blood test in a prospective, multi-site study: interim results. Clin Infect Dis. 2021;74:2136–2141.
Hamasur B, Bruchfeld J, van Helden P, et al. A sensitive urinary lipoarabinomannan test for tuberculosis. PLoS One. 2015;10:e0123457.
Broger T, Sossen B, du Toit E, et al. Novel lipoarabinomannan point-of-care tuberculosis test for people with HIV: a diagnostic accuracy study. Lancet Infect Dis. 2019;19:852–861.
Nicol MP, Schumacher SG, Workman L, et al. Accuracy of a novel urine test, Fujifilm SILVAMP tuberculosis lipoarabinomannan, for the diagnosis of pulmonary tuberculosis in children. Clin Infect Dis. 2021;72:e280–e288.
Graham SM, Cuevas LE, Jean-Philippe P, et al. Clinical case definitions for classification of intrathoracic tuberculosis in children: an update. Clin Infect Dis. 2015;61 Suppl 3:S179–S187.
Declation of Helsinki. Ethical principles for medical research involving human subjects. 2008.
Cuevas LE, Browning R, Bossuyt P, et al. Evaluation of tuberculosis diagnostics in children: 2. Methodological issues for conducting and reporting research evaluations of tuberculosis diagnostics for intrathoracic tuberculosis in children. Consensus from an expert panel. J Infect Dis. 2012;205 Suppl:S209–S215.
Graham SM, Ahmed T, Amanullah F, et al. Evaluation of tuberculosis diagnostics in children: 1. Proposed clinical case definitions for classification of intrathoracic tuberculosis disease. Consensus from an expert panel. J Infect Dis. 2012;205 Suppl 2:S199–S208.
Sabi I, Kabyemera R, Mshana SE, et al. Pulmonary TB bacteriologically confirmed by induced sputum among children at Bugando Medical Centre, Tanzania. Int J Tuberc Lung Dis. 2016;20:228–234.
Rachow A, Clowes P, Saathoff E, et al. Increased and expedited case detection by Xpert MTB/RIF assay in childhood tuberculosis: a prospective cohort study. Clin Infect Dis. 2012;54:1388–1396.
Anderson ST, Kaforou M, Brent AJ, et al. Diagnosis of childhood tuberculosis and host RNA expression in Africa. N Engl J Med. 2014;370:1712–1723.
Zar HJ, Workman L, Isaacs W, et al. Rapid diagnosis of pulmonary tuberculosis in African children in a primary care setting by use of Xpert MTB/RIF on respiratory specimens: a prospective study. Lancet Glob Heal. 2013;1:e97–104.
Bates M, Mudenda V, Mwaba P, et al. Deaths due to respiratory tract infections in Africa: a review of autopsy studies. Curr Opin Pulm Med. 2013;19:229–237.
Lawn SD, Kerkhoff AD, Burton R, et al. Diagnostic accuracy, incremental yield and prognostic value of Determine TB-LAM for routine diagnostic testing for tuberculosis in HIV-infected patients requiring acute hospital admission in South Africa: a prospective cohort. BMC Med. 2017;15:67.
Denoeud-Ndam L, Otieno-Masaba R, Tchounga B, et al. Integrating pediatric TB services into child healthcare services in Africa: study protocol for the INPUT cluster-randomized stepped wedge trial. BMC Public Health. 2020;20:623.
Vessière A, Font H, Gabillard D, et al. Impact of systematic early tuberculosis detection using Xpert MTB/RIF Ultra in children with severe pneumonia in high tuberculosis burden countries (TB-Speed pneumonia): a stepped wedge cluster randomized trial. BMC Pediatr. 2021;21:136.
Dongo JP, Graham SM, Nsonga J, et al. Implementation of an effective decentralised programme for detection, treatment and prevention of tuberculosis in children. Trop Med Infect Dis. 2021;6:131.
Banada PP, Naidoo U, Deshpande S, et al. A novel sample processing method for rapid detection of tuberculosis in the stool of pediatric patients using the Xpert MTB/RIF Assay. PLoS One. 2016;11:e0151980.
Walters E, Scott L, Nabeta P, et al. Molecular detection of Mycobacterium tuberculosis from stools in young children by use of a novel centrifugation-free processing method. J Clin Microbiol. 2018;56:e00781–e00818.
Penn-Nicholson A, Hraha T, Thompson EG, et al. Discovery and validation of a prognostic proteomic signature for tuberculosis progression: a prospective cohort study. PLoS Med. 2019;16:e1002880.
Chegou NN, Sutherland JS, Malherbe S, et al. Diagnostic performance of a seven-marker serum protein biosignature for the diagnosis of active TB disease in African primary healthcare clinic attendees with signs and symptoms suggestive of TB. Thorax. 2016;71:785–794.
Zak DE, Penn-Nicholson A, Scriba TJ, et al. A blood RNA signature for tuberculosis disease risk: a prospective cohort study. Lancet (London, England). 2016;387:2312–2322.