Case Series: Off-label Use of Dalbavancin in Pediatric Gram-positive Infections.

Abstract

Background: There is a growing interest in the use of dalbavancin as treatment for infections caused by Gram-positive microorganisms. Due to its long half-life, linear pharmacokinetics and good tolerability, it has been used in different clinical scenarios, including off-label indications. Studies are limited in children. The aim of this study was to assess the effectiveness and safety in real-world use of dalbavancin in children in Spain.

Methods: A retrospective study was conducted to describe the use of dalbavancin in children under 18 years of age admitted to 3 referral University hospitals in Spain until Jun 30, 2024.

Results: Fifteen patients were included, 66% male, with a median age of 7.1 years (interquartile range: 3.7-12.1). The most common infection was endocarditis (4, 26%) and endovascular infections (3, 20%), and the most frequently isolated microorganism was Staphylococcus aureus (9, 60%). The main reason to use dalbavancin was for consolidation treatment (15, 100%) to facilitate earlier hospital discharge (11, 73.3%). Dalbavancin was administered in one-dose regimen in 8 patients (53.3%), in two-dose regimen in 5 patients (30%) and multiple-dose regimen in 2 cases (13.3%). One patient developed macular rash and diarrhea and dalbavancin was discontinued. Fourteen patients (93%) were cured of infection at day 90.

Conclusions: Dalbavancin could be considered as a consolidation treatment for severe infections caused by Gram-positive microorganisms. It appears to be safe and effective in most children. Studies in the pediatric population to assess the use of dalbavacin in children are needed. A better understanding of the pharmacokinetics of dalbavancin in multiple-dose regimens is of special interest.