Dalbavancin Real-life Utilization in Diabetic Patients Suffering From Infections (DALBADIA)

Angelini Pharma

Status: Completed

Conditions: Infection; Diabetes

Treatments: Drug: Dalbavancin

Study type: Observational

Funder types: Industry

Identifiers

NCT04959799

146(Z)PO20094

Details and patient eligibility

About

The study aims to describe the current use of dalbavancin among diabetic patients with infections in a real-world clinical setting in Italy and Spain.

Full description

The study aims to describe the current use of dalbavancin in diabetic patients suffering from infections proven or suspected to be caused by Gram-positive or mixed Gram-positive and Gram-negative bacteria (with dalbavancin chosen for treating the Gram-positive component) in Italy and Spain.

As overall strategies to reduce the risk of developing severe infections and poor treatment outcomes among diabetic patients are under-researched and should be explored. This study could increase the knowledge of infection management among diabetic patients treated with dalbavancin in order to support appropriate clinical decision-making.

Enrollment: 98 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18 years at the time of dalbavancin treatment initiation
• Male and female patients
• Patients who received dalbavancin as targeted or empirical therapy to treat Gram-positive bacterial infection or as anti-Gram-positive component of a treatment regimen for mixed infection (e.g., with concurrent antibacterial or antifungals drugs for covering Gram-negative strains or fungi)
• Patients who received the last dose of dalbavancin according to the current standard clinical practice at least 30 (+7) days before enrolment in the study
• Patients with known type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) at the time of infectious disease of interest diagnosis
• Patients with available retrospective data in medical charts, including information about dalbavancin treatment and diabetes history
• Patients who gave informed consent and personal data processing consent to take part into the study following local regulation.

Exclusion criteria

• Patients enrolled in a clinical trial in which treatment with dalbavancin was managed through a study protocol
• Patients diagnosed with any hyperglycemic state other than T1DM or T2DM at the time of dalbavancin treatment initiation
• Patients with long-term infection (over than 12 months of duration) at the time of dalbavancin treatment initiation
• Previous participation in this study. Participation is defined as having given informed consent in this study
• Pregnant or breast-feeding patients from start time of dalbavancin treatment initiation till enrolment visit.