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

NCT04959799 | Completed

• 1 other identifier: 146(Z)PO20094
• Study Type: observational
• Target: 98
• Locations: 2 countries
• Sites: 11

Brief Summary

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.

Conditions

Diabetes; Infection

Keywords

Diabetes; ABSSSI; Infection; Gram-positive bacteria; Dalbavancin

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Demographic data

  4 weeks

• Clinical cure of dalbavancin

  Up to 8 weeks

• Microbiological success of dalbavancin

  Up to 8 weeks

• Incidence of Adverse Events

  Up to 8 weeks

Interventions

Dalbavancin DRUG

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.

Also known as: Xydalba

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aziende Chimiche Riunite Angelini Francesco S.p.A: lead
• Iqvia Pty Ltd: collaborator

Study Sites (11)

Ospedale Cardinal Massaia

Asti, 14100, Italy

Location

Azienda Ospedaliera Universitaria Federico II

Napoli, 80131, Italy

Location

Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone"

Palermo, 90127, Italy

Location

A.O.U. Pisana Presidio Ospedaliero Cisanello

Pisa, 56124, Italy

Location

Azienda Sanitaria Universitaria Friuli Centrale

Udine, 33100, Italy

Location

ASST dei Sette Laghi

Varese, Italy

Location

Hospital Universitario Fundación Alcorcón

Alcorcón, Madrid, 28922, Spain

Location

Hospital Clinic

Barcelona, 08036, Spain

Location

Hospital Universitario Virgen de las Nieves

Granada, 18014, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Universitario y Politécnico La Fe

Valencia, 46026, Spain

Location

Related Publications (1)

• Morata Ruiz L, Ruggieri A, Falcone M, Pasquau Liano J, Gentile I, Salavert Lleti M, Moreno Nunez L, Cascio A, Tascini C, Loeches Yague M, De Rosa FG, Ori A, Comandini A, Cattaneo A, Grossi PA; DALBADIA study group. Dalbavancin real-life utilization among diabetic patients suffering from infections in Italy and Spain: The DALBADIA retrospective cohort study. J Glob Antimicrob Resist. 2024 Mar;36:200-209. doi: 10.1016/j.jgar.2023.11.015. Epub 2024 Jan 10.

  PMID: 38211660 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Infections

Interventions

dalbavancin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: July 13, 2021
• Study Start: January 2, 2022
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: September 21, 2022

Record last verified: 2022-09

Locations

IT (6); ES (5)