Clinical trial NCT04959799: Dalbavancin Real-life Utilization in Diabetic Patients Suffering From Infections (DALBADIA)
Official title: Retrospective Observational Study on Dalbavancin Real-life Utilization in Diabetic Patients Suffering From Infections - DALBADIA Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Infection
Keywords: Diabetes
ABSSSI
Infection
Gram-positive bacteria
Dalbavancin
Lead sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A
Sponsor class: INDUSTRY
Collaborators: name: Iqvia Pty Ltd
First posted: 2021-07-13
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Retrospective description of the dalbavancin treatment in diabetic patients.
timeFrame: 4 weeks
measure: Retrospective description of the utilization of dalbavancin treatment in diabetic patients.
timeFrame: 4 weeks
measure: Retrospective description of the setting of dalbavancin treatment in diabetic patients.
timeFrame: 4 weeks
Secondary outcomes:
measure: Demographic data
timeFrame: 4 weeks
measure: Clinical cure of dalbavancin
timeFrame: Up to 8 weeks
measure: Microbiological success of dalbavancin
timeFrame: Up to 8 weeks
measure: Incidence of Adverse Events
timeFrame: Up to 8 weeks
Other outcomes:
Locations:
city: Asti
country: Italy
facility: Ospedale Cardinal Massaia
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II
city: Palermo
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone"
city: Pisa
country: Italy
facility: A.O.U. Pisana Presidio Ospedaliero Cisanello
city: Udine
country: Italy
facility: Azienda Sanitaria Universitaria Friuli Centrale
city: Varese
country: Italy
facility: ASST dei Sette Laghi
city: Alcorcón
country: Spain
facility: Hospital Universitario Fundación Alcorcón
state: Madrid
city: Barcelona
country: Spain
facility: Hospital Clinic
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Valencia
country: Spain
facility: Hospital Universitario y Politécnico La Fe
Study officials:
References: