Objectives: To investigate the safety profiles and clinical outcomes in a continuous cohort of tuberculosis (TB) patients from a clinical referral centre in Germany receiving self-administered outpatient parenteral antimicrobial therapy (sOPAT)., Methods: We conducted a retrospective observational cohort study of patients receiving sOPAT after discharge from the Research Center Borstel in Germany between January 2015 and December 2020. Data were extracted from medical records., Results: In the observation period, 150 patients received parenteral antibiotics at the Research Center Borstel. Of these, 89 received sOPAT via a port catheter and were further analysed. The majority were male (n = 59, 66.3%), with a median age of 33.6 years (interquartile range-IQR 26.2-42.8). Most patients had multidrug-resistant (MDR)-TB (n = 56, 62.9%) or pre-extensively drug resistant (pre-XDR)-TB (n = 21; 23.6%). Fifty-eight (65.2%) patients received one and 24 patients (27.0%) received two parenteral drugs, most commonly capreomycin (n = 53, 59.6%) and meropenem (n = 44, 49.4%). The median duration of sOPAT was 7.4 months (IQR 5.2-17.2). In total, 71,128 intravenous drug administrations were recorded. One patient died of TB while another patient was lost to follow-up. Sixty-two (69.7%) patients completed the sOPAT regimen, the most common reason for premature discontinuation was adverse drug events (n = 12, 13.5%). There were eight (9.0%) port-related complications requiring port explantation (bloodstream infections: n = 6, local infection: n = 1, port thrombosis: n = 1)., Conclusions: In selected patients requiring long-term intravenous anti-TB therapy, sOPAT is a feasible treatment option with a low risk of complications when adequate infrastructure and training are in place., Competing Interests: Declarations. Funding: Open Access funding enabled and organized by Projekt DEAL. This work was supported by the German Center for Infection Research under grant agreement TTU-TB 02.709. Data availability: The data that support the findings of this study are not openly available due to reasons of sensitivity and are available from the corresponding author upon reasonable request. Data are located in controlled access data storage at the Research Center Borstel, Leibniz Lung Center. Conflict of interest: Niklas Köhler reports receiving project grants from the Schleswig-Holstein Society for Prevention and Control of Tuberculosis and Pulmonary Diseases for work outside the scope of the submitted work. Christoph Lange reports a grant from the German Center for Infection Research. He holds leadership roles in TBNET and The International Union against TB and Lung Diseases and received honoraria from GSK, Gilead, Insmed, and MedUpdate for speaking engagements, outside the scope of the submitted work. Barbara Kalsdorf received speaker honoraria for lectures from Insmed Germany GMBH, and Astra Zeneca Deutschland, as well as support for attending meetings and/or travel from Astra Zeneca Deutschland, GSK Deutschland, and Boehringer Ingelheim Deutschland, outside the scope of the submitted work. Anika Rauch, Thomas Theo Brehm, Nika Zielinski, Krista Stoycheva, Christina Maier, Laura Böttcher, Inna Friesen, Dagmar Schaub, Maja Reimann and Stefan Schmiedel each report no conflict of interest related to the manuscript. Author contribution: Anika Rauch: conceptualisation, methodology, validation, formal analysis, investigation, data curation, writing—original draft, visualisation, project administration. Niklas Köhler: conceptualisation, methodology, validation, formal analysis, investigation, data curation, writing—original draft, visualisation, project administration. Thomas Theo Brehm: methodology, formal analysis, investigation, writing—original draft, supervision. Nika Zielinski: methodology, software, formal analysis, investigation, data curation, writing—original draft, visualisation. Krista Stoycheva: methodology, investigation, writing—review and editing, project administration. Christina Maier: conceptualisation, validation, formal analysis, investigation, resources, data curation, writing—original draft. Laura Böttcher: conceptualisation, validation, investigation, resources, data curation, writing—original draft. Inna Friesen: validation, resources, writing—review and editing, supervision. Dagmar Schaub: formal analysis, investigation, data curation, writing—review and editing, project administration. Maja Reimann: conceptualisation, methodology, validation, formal analysis, investigation, data curation, writing—original draft, visualisation, supervision. Stefan Schmiedel: conceptualisation, methodology, writing—review and editing, visualisation, supervision. Christoph Lange: conceptualisation, methodology, investigation, resources, writing—original draft, supervision, project administration, funding acquisition. Barbara Kalsdorf: conceptualisation, methodology, investigation, resources, writing—original draft, supervision, project administration. Ethics approval: Ethical approval was waived by the local Ethics Committee of University of Lübeck (24-215) in view of the retrospective nature of the study and all the procedures being performed were part of the routine care., (© 2024. The Author(s).)