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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Retrospective Observational Study on Dalbavancin Real-life Utilization in Diabetic Patients Suffering From Infections - DALBADIA Study

Conditions
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Diabetes, Infection

Intervention / Treatment
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* Drug: Dalbavancin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Dalbavancin|Adult diabetic patients suffering from infections who received the last dose of dalbavancin according to the current standard clinical practice at least 30 (+7) days before enrolment in the study.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retrospective description of the dalbavancin treatment in diabetic patients. | Evidence of dalbavancin treatment choice (number and dates of infusions) | 4 weeks | 
| Retrospective description of the utilization of dalbavancin treatment in diabetic patients. | Evidence of dalbavancin treatment choice (starting and subsequent dosage) | 4 weeks | 
| Retrospective description of the setting of dalbavancin treatment in diabetic patients. | Evidence of dalbavancin treatment choice (setting of infusion) | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographic data | Demographic data description (Age and Gender) | 4 weeks | 
| Clinical cure of dalbavancin | Number of patients with clinical cure evaluated by physicians at end of dalbavancin treatment (i.e., date of last dalbavancin dose administration). Clinical cure is defined as clinical signs and symptoms resolved. | Up to 8 weeks | 
| Microbiological success of dalbavancin | Number of patients with microbiological success at end of dalbavancin treatment (i.e., date of last dalbavancin dose administration). Microbioligical success is defined as culture-confirmed eradication of the Gram-positive pathogens identified at baseline, documented as a negative bacterial culture from the same site as the initial positive baseline culture | Up to 8 weeks | 
| Incidence of Adverse Events | Safety profile was assessed through the incidence of Adverse Events occurred in patients treated with dalbavancin. | Up to 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, ABSSSI, Infection, Gram-positive bacteria, Dalbavancin