Dalbavancin and oritavancin in long-term suppressive therapy: Use, safety, dosing regimens and the role of therapeutic drug monitoring, protocol for a systematic review.

OBJECTIVE

To develop a protocol for a systematic review aimed to evaluate the existing evidence on the use of dalbavancin and oritavancin as suppressive therapy, focusing on their efficacy, effectiveness and safety across different infectious diseases and therapeutic use protocols.

METHODS

A systematic review of studies involving patients treated with dalbavancin and/or oritavancin as suppressive therapy will be performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The main outcomes of interest are the efficacy, effectiveness and safety of these treatments as suppressive therapy. Searches will be performed in MEDLINE (PubMed), Embase (Ovid), the Cochrane Central Register of Controlled Trials, and the Latin American and Caribbean Health Sciences Literature database. English- and Spanish-language literature will be included, with no date restrictions. Studies including patients treated with dalbavancin and/or oritavancin as long-term suppressive therapy in adults will be included; studies in which these treatments were used for other purposes will be excluded. Reviews, abstracts, protocols, duplicates, and grey literature will be excluded. Data from the studies will be synthesised in both tabular and narrative form according to the Synthesis Without Meta-analysis reporting guidelines. Extracted data will include study design, patient characteristics, infection type, causative pathogens, dosing regimens, clinical outcomes, adverse events, and therapeutic drug monitoring targets and measurements. Data from these studies will be grouped by the drug(s) reported, infection type, isolated pathogen and used dosing regimens. The methodological quality of included studies will be assessed using the Joanna Briggs Institute critical appraisal tools. The article selection, data extraction, and quality assessment processes will be carried out by two independent reviewers, with a third to resolve discrepancies. This protocol has been reported to follow the recommendations stated by the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols. This protocol was registered in the International Prospective Register of Systematic Reviews of the Center for Reviews and Dissemination (registration number: CRD420251054127).

DISCUSSION: The current evidence on this topic is mainly limited to small studies, which show considerable variability in treatment schedules and reported outcomes. The protocol for this systematic review is the first step to synthesise evidence on this topic to support decision-making.