Dalbavancin 500mg powder for solution for infusion vials

Background: Dalbavancin and oritavancin are long-acting lipoglycopeptides increasingly used off-label for a variety of Gram-positive infections. While their efficacy has been described in osteomyelitis, bacteremia, and infective endocarditis, evidence specifically addressing cardiovascular prosthetic infections such as prosthetic valve endocarditis (PVE), cardiac implantable electronic device (CIED) infections, left ventricular assist device infections (LVAD), and prosthetic vascular graft infections (PVGI) remains limited. These conditions are particularly challenging due to biofilm formation, difficulties in achieving surgical source control, and the frequent need for prolonged or suppressive therapy. Objectives: This systematic review aimed to summarize the available literature on the use of dalbavancin and oritavancin in cardiovascular prosthetic infections, with a focus on therapeutic strategies, clinical outcomes, and safety. Methods: We performed a systematic search of PubMed, Embase, Scopus, and Cochrane Library up to 24 June 2025 in accordance with PRISMA guidelines. Eligible studies included adults treated with dalbavancin or oritavancin for cardiovascular prosthetic infections. Data on study characteristics, population demographics, causative pathogens, and microbiological profiles, antibiotic regimens, treatment duration, use of therapeutic drug monitoring (TDM), indication or non-indication for chronic suppressive therapy, adverse events, clinical outcomes, and clinical efficacy were extracted. Results: Twenty studies comprising 113 patients were identified, of whom 111 received dalbavancin and 2 oritavancin. The main infections were PVE, CIED, LVAD, and PVGI. Dalbavancin was most effective as consolidation therapy after surgery or device removal, with high cure rates. Prolonged regimens were used as bridging or in partially treated cases, sometimes supported by TDM or PET/CT. Chronic suppressive therapy, mainly for LVAD and PVGI infections, achieved variable outcomes with relapses in about one fifth of patients. Adverse events were infrequent and generally mild. Conclusions: The included studies were highly diverse, conducted in various settings and with different objectives. Eight of the twenty included studies were single case reports on dalbavancin and oritavancin, highlighting the predominance of individual case descriptions in the available literature. Long-acting lipoglycopeptides may represent a valuable option for cardiovascular prosthetic infections. Their role appears most favorable as consolidation after adequate source control, while chronic suppressive use showed heterogeneous outcomes. This systematic review was registered on Open Science Framework. This work was supported by grants from the Italian Ministry of Health through Ricerca Corrente, Linea 3, Progetto 3.

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ObjectivesThe aim of this work was to perform a systematic review assessing the pharmacokinetic/pharmacodynamic (PK/PD) properties of dalbavancin and the clinical use for in-label and off-label indications in pediatric patients.MethodsTwo authors independently searched the PubMed-MEDLINE and Scopus databases and clinicaltrials.gov up to 20 November 2024, to retrieve randomized controlled trials (RCTs), observational studies, PK studies, and case series/reports assessing dalbavancin PK/PD properties or the clinical use for both in-label and off-label indications in pediatric patients. Data were independently extracted by the two authors, and the quality of the included studies was independently assessed by means of specific tools according to study design. Clinical success was selected as the primary outcome. Descriptive statistics were used for summarizing the retrieved data. Subgroup analysis according to PK/PD data, as well as in-label and off-label indications, was performed.ResultsAfter screening 206 articles, nine studies were included in the systematic review (one RCT, three PK studies, and five case series/reports; n = 267). Dalbavancin exposure was 30% lower in pediatric patients compared to adults. In acute bacterial skin and skin structure infections (ABSSSIs), the overall clinical success of dalbavancin was 96.1-97.3% and 92.9% in RCT and case series, respectively. Bone and joint infections (60.7%) and central-line-associated bloodstream infections (14.3%) represented the most common dalbavancin off-label indications in pediatric patients. Overall, the clinical success for off-label indications was 92.9%. The rate of adverse events ranged from 7.1% to 10.7%.ConclusionsOur systematic review summarized evidence concerning the PK/PD properties of dalbavancin and its use for in-label or off-label indications in pediatric patients. The available findings suggest that dalbavancin may be a valuable alternative for the management of ABSSSIs and/or off-label indications in pediatric patients according to efficacy and safety data, allowing for a potential minimized duration of hospital stay.

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Gram-positive infections are associated with significant morbidity and healthcare burden, often requiring prolonged intravenous therapy. Dalbavancin, a long-acting lipoglycopeptide, has emerged as a promising option beyond its approved indication for acute bacterial skin and skin structure infections (ABSSSI). A systematic review was conducted according to the PRISMA guidelines (PROSPERO: CRD420261296328). MEDLINE, Embase, CENTRAL, and Web of Science were searched from inception. Randomized controlled trials (RCTs) and observational studies evaluating dalbavancin in adult patients with Gram-positive infections were included. Outcomes of interest were clinical effectiveness, safety, and healthcare resource utilization. Risk of Bias was assessed using RoB 2 and the Newcastle-Ottawa Scale. Twenty-one studies were included. Randomized trials confirmed non-inferior efficacy of dalbavancin compared with standard therapy in ABSSSI. Observational studies demonstrated high clinical success rates across a range of infections, including osteo-articular infections, bloodstream infections, and infective endocarditis (IE), particularly in acute settings. Lower effectiveness was observed in biofilm-related infections without adequate source control. Dalbavancin was frequently used as sequential or consolidation therapy in complex patients. Its use was consistently associated with reduced length of hospital stay, facilitation of outpatient management, and potential cost savings. The safety profile was favorable, including in prolonged or multi-dose regimens. In conclusion, dalbavancin represents an effective and well-tolerated option for Gram-positive infections, with expanding evidence supporting its use in complex and off-label settings. Its pharmacokinetic profile enables simplified treatment strategies and improved healthcare resource utilization, although appropriate patient selection and source control remain essential.

Abstract licence: CC BY