A1 Refereed original research article in a scientific journal
Clinical standards for antimicrobial stewardship in TB care
Authors: Brehm, T. T.; Akkerman, O. W.; Sotgiu, G.; Tiberi, S.; Chang, K.-C.; Dheda, K.; Duarte, R.; Vambe, D.; Udwadia, Z. F.; Chesov, D.; Mendelson, M.; Iswari Saktiawati, A. M.; van Ingen, J.; Eyuboglu, F. O.; Tängdén, T.; Quang Vo, L. N.; Riccardi, N.; Moschos, C.; Friedland, J. S.; Lillebaek, T.; Chandy, S. J.; Caminero, J. A.; Thwaites, G.; Gandra, S.; Thursky, K.; George, I. A.; Konstantynovska, O.; Fatima, R.; Yim, J.-J.; Kwak, N.; Olaru, I. D.; Gillespie, S.H.; Kherabi, Y.; Perl, S. H.; Grønningen, E.; Rodrigues, C.; Bjerrum, S.; Bange, F.; Cox, V.; Cirillo, D. M.; Saluzzo, F.; Hara, G. L.; Wagner, D.; Ismail, N.; Sloan, D. J.; Eshun-Wilsonova, I.; Zeng, M.; Cantero, C.; Vasankari, T.; Mandalakas, A.; Kay, A.; Ness, T.; Torrico, M. M.; Günther, G.; Kuksa, L.; Guglielmetti, L.; García-Basteiro, A. L.; Marks, G. B.; Pulcini, C.; Lange, C.
Publisher: International Union Against Tuberculosis and Lung Disease
Publication year: 2025
Journal: IJTLD Open
Volume: 2
Issue: 12
First page : 716
Last page: 726
eISSN: 3005-7590
DOI: https://doi.org/10.5588/ijtldopen.25.0522
Publication's open availability at the time of reporting: Open Access
Publication channel's open availability : Open Access publication channel
Web address : https://doi.org/10.5588/ijtldopen.25.0522
Self-archived copy’s web address: https://research.utu.fi/converis/portal/detail/Publication/506081162
While antimicrobial stewardship (AMS) is essential for combating antimicrobial resistance (AMR), TB-specific AMS strategies remain poorly defined.
An international panel of 62 experts participated in a Delphi process. Using a 5-point Likert scale (5 = strong agreement; 1 = strong disagreement), participants evaluated 10 draft clinical standards developed by a core coordination team. A standard was adopted if ≥90% of respondents rated it three or higher, according to a predefined consensus threshold.
All 10 standards reached the consensus threshold and were adopted: Standard 1, integration of TB into national AMR action plans; Standard 2, implementation of TB surveillance systems; Standard 3, education of health care providers, individuals affected by TB, and the public; Standard 4, integration of TB into AMS activities; Standard 5, establishment of expert consultation services; Standard 6, targeted testing and preventive treatment for individuals at risk for TB; Standard 7, access to timely and comprehensive drug susceptibility testing; Standard 8, prioritisation of efficacy, safety, and resistance prevention in TB treatment regimens; Standard 9, clinical and microbiological monitoring of treatment response; and Standard 10, assessment of adherence, drug exposure, and resistance in treatment failure.
These clinical standards aim to support clinicians, programme managers, and public health authorities in implementing effective, TB-specific AMS strategies.
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Funding information in the publication:
OWA received a grant from St NN Beatrixoord. SB received funding from the World Health Organization as a consultant for a systematic review on TB diagnostics (payment made to Odense University Hospital for distribution to the systematic reviewers involved). DMC reports the Unite4TB Innovative Medicines Initiative grant (UniSR, leading WP6), coordination of ERLNTBnet3 supported by the European Centre for Disease Prevention and Control, and the EX-DR Horizon EDCTP project. JSF reports research grant funding from the UK Medical Research Council and the Rosetrees Trust. SHG reports support from the European and Developing Countries Clinical Trials Partnership (EDCTP) for the SimpliciTB clinical trial. LG reports a grant from Unitaid to Medecins ´ Sans Frontieres ` for the endTB project, for which he was co-principal investigator of two Phase III clinical trials (endTB and endTB-Q). He also reports funding for the FAST-MDR Phase III clinical trial, which he leads as principal investigator, from the French National Hospital Program for Clinical Research (PHRC) and through a pro bono donation from Viatris. His work is also supported by the Italian Ministry of Health with funds to IRCCS Sacro Cuore Don Calabria hospital - ‘Ricerca corrente’, Linea 39. GG reports funding from the Swiss Lung Association. CL is supported by the German Center for Infection Research (DZIF). LNQV reports organizational grants with salary support from the Stop TB Partnership TB REACH, UNITAID–Liverpool School of Tropical Medicine, and GHIT–Stop TB Partnership. IDO reports funding from the World Health Organization. DW reports funding from the DAAD Nozgeka Master Programme in Malawi, participation in clinical studies funded by Insmed, the GIZ Clinical Partnership with Malawi, and the BMBF project on digital instruments for tuberculosis control in Kyrgyzstan and Armenia. J-JY reports a research grant from Otsuka Pharmaceutical Co. for the study ‘Registry on the Effectiveness and Safety of the 9-month MDR-END Treatment Regimen (Delamanid, Linezolid, Levofloxacin, Pyrazinamide) in Korean Patients with Fluoroquinolone-Sensitive Pulmonary Multi-Drug Resistant Tuberculosis (MDR-TB): A Non-interventional, Prospective Observational Study (MDR-END Registry).
