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NCT Number: NCT04959799

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Infection Infections Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale Cardinal Massaia, Asti, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Xydalba

Primary outcomes

  1. Retrospective description of the dalbavancin treatment in diabetic patients.

    Time frame: 4 weeks

    Evidence of dalbavancin treatment choice (number and dates of infusions)

  2. Retrospective description of the utilization of dalbavancin treatment in diabetic patients.

    Time frame: 4 weeks

    Evidence of dalbavancin treatment choice (starting and subsequent dosage)

  3. Retrospective description of the setting of dalbavancin treatment in diabetic patients.

    Time frame: 4 weeks

    Evidence of dalbavancin treatment choice (setting of infusion)

Secondary outcomes

  1. Demographic data

    Time frame: 4 weeks

    Demographic data description (Age and Gender)

  2. Clinical cure of dalbavancin

    Time frame: Up to 8 weeks

    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.

  3. Microbiological success of dalbavancin

    Time frame: Up to 8 weeks

    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

  4. Incidence of Adverse Events

    Time frame: Up to 8 weeks

    Safety profile was assessed through the incidence of Adverse Events occurred in patients treated with dalbavancin.

Sponsors and collaborators

Lead sponsor

Aziende Chimiche Riunite Angelini Francesco S.p.A

Industry

Collaborators

  • IQVIA Pty Ltd

Registry information

Official study title

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

Acronym: DALBADIA

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 13, 2021
Registry last updated
Sep 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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