Clinical Outcomes of Delamanid-Containing Regimens in Patients with Drug-Resistant Pulmonary Tuberculosis: A Prospective Observational Study

Abstract

Drug-resistant pulmonary tuberculosis (DR-PTB) remains a major public health challenge owing to prolonged treatment, limited therapeutic options, and suboptimal treatment outcomes. Delamanid has emerged as an important component of individualized regimens for multidrug-resistant and rifampicin-resistant tuberculosis, particularly in patients with fluoroquinolone resistance or intolerance to conventional second-line drugs. This prospective observational study evaluated the effectiveness, safety, tolerability, and treatment outcomes of delamanid-containing regimens in patients with drug-resistant pulmonary tuberculosis managed at a tertiary care centre in South India. Twenty adult patients with microbiologically confirmed drug-resistant pulmonary tuberculosis who received delamanid-containing treatment were enrolled between February 2024 and August 2025. Demographic, clinical, microbiological, radiological, laboratory, and treatment-related data were prospectively collected. Treatment response, adverse drug reactions, QTc interval changes, treatment adherence, and final outcomes were assessed. Most patients had pre-extensively drug-resistant tuberculosis (85.0%), and fluoroquinolone resistance was the most common indication for delamanid therapy (80.0%). Delamanid-containing regimens were generally well tolerated, with only isolated adverse events, including nausea, vomiting, epigastric burning, QTc prolongation, and hypokalaemia (5.0% each). No hepatotoxicity or treatment discontinuation due to adverse drug reactions was observed. Nineteen patients (95.0%) were cured, while one patient (5.0%) was lost to follow-up and subsequently died. Delamanid-containing regimens demonstrated excellent effectiveness, good tolerability, and a favourable safety profile in this cohort. These findings support the use of delamanid as an important component of individualized treatment regimens for drug-resistant pulmonary tuberculosis under routine programmatic conditions.