Treatment Outcomes and Loss to Follow-Up in Tuberculosis: A Real-World Cohort Study from Sicily, Italy
Year: 2026
Type: preprint
Abstract: Background Tuberculosis (TB) remains a major cause of morbidity and mortality worldwide. Its management is frequently complicated by prolonged treatment, drug-related toxicity, antimicrobial resistance, and difficulties in maintaining long-term follow-up. We aimed to describe the clinical characteristics, management, and treatment outcomes of patients with TB treated at a tertiary referral center in Sicily, Italy. Methods We conducted a retrospective observational study of consecutive patients with TB managed between January 2021 and December 2023. Demographic, clinical, microbiological, treatment-related, and outcome data were collected. Outcomes included treatment completion, loss to follow-up (LTFU), transfer to another center, treatment failure, relapse, and death. Factors associated with treatment completion were evaluated using multivariable logistic regression. Results Among 164 patients, 130 (79.2%) were male, and 105 (64.0%) were born outside Italy. Pulmonary TB was diagnosed in 141 patients (86.0%), including 82 (58.2%) with concomitant extrapulmonary involvement. Microbiological confirmation was obtained in 106 (64.6%). Phenotypic drug susceptibility testing was available for 50 patients, of whom 17 (34.0%) showed resistance to at least one drug tested. Adverse drug reactions occurred in 37 patients (22.6%), most commonly hepatotoxicity, and led to treatment modification in 35. By the end of follow-up, 95 patients (57.9%) had completed treatment, 53 (32.3%) were LTFU, 5 (3.0%) had been transferred to another center, and 11 (6.7%) had died. Treatment failure and relapse were each documented in one patient. Five deaths were directly attributable to TB, whereas six were related to underlying or concomitant comorbidities. Foreign-born status was independently associated with lower likelihood of treatment completion (adjusted OR, 0.260; 95% CI, 0.106–0.641; p = 0.003). Conclusions In this real-world cohort, TB management was characterized by substantial clinical complexity and a high rate of LTFU. Foreign-born patients were significantly less likely to complete treatment, underscoring the need for patient-centered strategies to strengthen long-term engagement and reduce LTFU.
Source: Research Square
Authors: Luca Pipitò, Chiara Vincenza Mazzola, Claudia Conti, Domenico Graceffa, Eleonora Bono, Costanza Giordano, Annamaria Vitale, Giulio D'Agati, Laura Causa, Sofia Urso, Rita Immordino, Salvatore Antonino Distefano, Antonella Bartolone, Floriana Di Figlia, Sara Cannella, Edoardo Mandalà, Gaetano D'Alessandro, Silvia Bonura, Paola Di Carlo, Giovanni Maurizio Giammanco, Antonio Cascio, Celestino Bonura
Language: English
Subfield: Infectious Diseases
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W7225646965
