The Safety and Efficacy of Dalbavancin and Active Comparator in Pediatric Patients With Acute Bacterial Skin and Skin Structure Infections.

Autor:	Giorgobiani M; From the JSC Evex Hospitals, Tbilisi, Georgia., Burroughs MH; AbbVie Inc., North Chicago, Illinois., Antadze T; From the JSC Evex Hospitals, Tbilisi, Georgia., Carrothers TJ; AbbVie Inc., Madison, New Jersey., Riccobene TA; AbbVie Inc., Madison, New Jersey., Patel R; AbbVie Inc., Madison, New Jersey., Lin T; AbbVie Inc., Madison, New Jersey., Stefanova P; Medical University of Plovdiv and University Hospital 'St. George,' Plovdiv, Bulgaria.
Jazyk:	angličtina
Zdroj:	The Pediatric infectious disease journal [Pediatr Infect Dis J] 2023 Mar 01; Vol. 42 (3), pp. 199-205. Date of Electronic Publication: 2022 Dec 07.
DOI:	10.1097/INF.0000000000003798
Abstrakt:	Background: Acute bacterial skin and skin structure infections (ABSSSIs) are a significant source of morbidity in children. Dalbavancin, approved for the treatment of adults and children with ABSSSI, has a well-established safety profile in adults. We report safety and descriptive efficacy data for the treatment of ABSSSI in children. Methods: Children with ABSSSI (birth-<18 years old) or sepsis (<3 months old) known/suspected to be caused by susceptible Gram-positive organisms were enrolled in this phase 3, multicenter, open-label, comparator-controlled study (NCT02814916). Children ≥3 months old were randomized 3:3:1 to receive single-dose dalbavancin, 2-dose dalbavancin, or a comparator antibiotic in 4 age cohorts; those <3 months old received single-dose dalbavancin. Clinical response and microbiologic efficacy were evaluated 48-72 hours and 14, 28 and 54 days posttreatment. Bowel flora testing and audiology were collected in a subset of patients at baseline and day 28. Adverse events (AEs) were collected throughout the study. Results: Treatment-emergent AEs occurred in 7.2%, 9.0% and 3.3% of patients in dalbavancin single-dose, dalbavancin 2-dose and comparator arms, respectively. Three serious AEs occurred in the dalbavancin single-dose arm; no treatment-related AEs, serious AEs, or AEs leading to study discontinuation were reported. Favorable clinical response at 48-72 hours was documented in 97.4%, 98.6% and 89.7% of patients. Safety and efficacy were comparable across age cohorts. The microbiologic intent-to-treat population had comparable clinical response for all baseline pathogens, including methicillin-resistant Staphylococcus aureus . Conclusion: The safety profile of dalbavancin was consistent in children and adults with ABSSSI. No new safety signals were identified. Competing Interests: M.H.B., T.A.R. and R.P. are employees of AbbVie and own AbbVie stock. T.J.C. and T.L. were AbbVie employees at the time of study conduct and analysis. The other authors have no conflicts of interest to disclose. (Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc.)
Databáze:	MEDLINE
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