Treatment Outcomes and Adverse Events of a Delamanid-Based All-Oral Regimen in Children with Drug-Resistant Tuberculosis
Sushant Mane, Pranita Shirsat, Manas Pustake, Kaif Charania, Rohit KukadeAbstract
Background:
The emergence of drug-resistant tuberculosis (DR-TB), particularly multidrug-resistant (MDR-TB) and extensively drug-resistant (XDR-TB), presents a significant challenge in pediatric populations. Delamanid (DLM), a novel nitro-dihydro-imidazo-oxazole, offers promise for all-oral, injectable-free regimens. This study evaluated the outcomes and safety of a DLM-based all-oral regimen in children with DR-TB.
Materials and Methods:
This prospective, observational study was conducted over 1.5 years. Children aged 6–18 years with confirmed or probable DR-TB (MDR, preextensively drug-resistant [pre-XDR], or XDR) were enrolled. Participants received a DLM-based regimen as per National Tuberculosis Elimination Programme (NTEP) guidelines (50 mg twice daily [BID] for 6–11 years; 100 mg BID for 12–18 years) alongside an optimized background regimen. Primary outcomes were treatment success (cured or completed). Secondary outcomes assessed adverse drug reactions (ADRs) graded as per Common Terminology Criteria for Adverse Events version 5.0.
Results:
Sixty children were enrolled with a mean (±SD) age of 13.48 (±2.69) years and a female predominance of 71.7%. Resistance patterns were as follows: MDR-TB (33.33%), pre-XDR-TB (51.67%), and XDR-TB (15%). Disease sites included pulmonary (38.34%), extrapulmonary (33.33%), and disseminated (28.33%). Overall treatment success was 91.67% (45% cured and 46.67% completed treatment). Mortality was 8.33% (
Conclusion:
A DLM-based all-oral regimen is effective and well-tolerated for treating children with DR-TB, achieving excellent treatment success rates. The manageable safety profile, dominated by low-grade ADRs, supports its use as a core agent in pediatric DR-TB therapy, facilitating better compliance than injectable-containing regimens.