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

Diabetes Clinical Trial

— DALBADIA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04959799
• Other study ID #: 146(Z)PO20094
• Status: Completed
• Start date: January 2, 2022
• Est. completion date: May 31, 2022

Study information

• Verified date: September 2022
• Source: Aziende Chimiche Riunite Angelini Francesco S.p.A
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Diabetes
• Infection
• Infections

Intervention

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.

Locations

Country	Name	City	State
Italy	Ospedale Cardinal Massaia	Asti
Italy	Azienda Ospedaliera Universitaria Federico II	Napoli
Italy	Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone"	Palermo
Italy	A.O.U. Pisana Presidio Ospedaliero Cisanello	Pisa
Italy	Azienda Sanitaria Universitaria Friuli Centrale	Udine
Italy	ASST dei Sette Laghi	Varese
Spain	Hospital Universitario Fundación Alcorcón	Alcorcón	Madrid
Spain	Hospital Clinic	Barcelona
Spain	Hospital Universitario Virgen de las Nieves	Granada
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario y Politécnico La Fe	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
Aziende Chimiche Riunite Angelini Francesco S.p.A	Iqvia Pty Ltd

Countries where clinical trial is conducted

Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retrospective description of the dalbavancin treatment in diabetic patients.	Evidence of dalbavancin treatment choice (number and dates of infusions)	4 weeks
Primary	Retrospective description of the utilization of dalbavancin treatment in diabetic patients.	Evidence of dalbavancin treatment choice (starting and subsequent dosage)	4 weeks
Primary	Retrospective description of the setting of dalbavancin treatment in diabetic patients.	Evidence of dalbavancin treatment choice (setting of infusion)	4 weeks
Secondary	Demographic data	Demographic data description (Age and Gender)	4 weeks
Secondary	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
Secondary	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
Secondary	Incidence of Adverse Events	Safety profile was assessed through the incidence of Adverse Events occurred in patients treated with dalbavancin.	Up to 8 weeks