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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes; Infection
• Intervention / Treatment: Drug: Dalbavancin

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 98

Contacts and Locations

Study Locations

• Italy
  • Asti, Italy, 14100
    • Ospedale Cardinal Massaia
  • Napoli, Italy, 80131
    • Azienda Ospedaliera Universitaria Federico II
  • Palermo, Italy, 90127
    • Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone"
  • Pisa, Italy, 56124
    • A.O.U. Pisana Presidio Ospedaliero Cisanello
  • Udine, Italy, 33100
    • Azienda Sanitaria Universitaria Friuli Centrale
  • Varese, Italy
    • ASST dei Sette Laghi
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic
  • Granada, Spain, 18014
    • Hospital Universitario Virgen de las Nieves
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Valencia, Spain, 46026
    • Hospital Universitario y Politécnico La Fe
  • Madrid
    • Alcorcón, Madrid, Spain, 28922
      • Hospital Universitario Fundación Alcorcón

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A
• Collaborators: IQVIA Pty Ltd

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 2, 2022
• Primary Completion (ACTUAL): May 31, 2022
• Study Completion (ACTUAL): May 31, 2022

Study Registration Dates

• First Submitted: June 21, 2021
• First Submitted That Met QC Criteria: July 12, 2021
• First Posted (ACTUAL): July 13, 2021

Study Record Updates

• Last Update Posted (ACTUAL): September 21, 2022
• Last Update Submitted That Met QC Criteria: September 19, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Diabetes; Infection; ABSSSI; Dalbavancin; Gram-positive bacteria
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Anti-Infective Agents; Anti-Bacterial Agents; Dalbavancin
• Other Study ID Numbers: 146(Z)PO20094

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No