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

Sponsor

Aziende Chimiche Riunite Angelini Francesco S.p.A (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04959799

Collaborator

Iqvia Pty Ltd (Industry)

100

Enrollment

Locations

5.9

Anticipated Duration (Months)

9.1

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Infection	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 Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jan 2, 2022

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Jun 30, 2022

Outcome Measures

Primary Outcome Measures

Retrospective description of the dalbavancin treatment in diabetic patients. [4 weeks]
Evidence of dalbavancin treatment choice (number and dates of infusions)
Retrospective description of the utilization of dalbavancin treatment in diabetic patients. [4 weeks]
Evidence of dalbavancin treatment choice (starting and subsequent dosage)
Retrospective description of the setting of dalbavancin treatment in diabetic patients. [4 weeks]
Evidence of dalbavancin treatment choice (setting of infusion)

Secondary Outcome Measures

Demographic data [4 weeks]
Demographic data description (Age and Gender)
Clinical cure of dalbavancin [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.
Microbiological success of dalbavancin [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
Incidence of Adverse Events [Up to 8 weeks]
Safety profile was assessed through the incidence of Adverse Events occurred in patients treated with dalbavancin.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ospedale Cardinal Massaia	Asti		Italy	14100
2	Azienda Ospedaliera Universitaria Federico II	Napoli		Italy	80131
3	Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone"	Palermo		Italy	90127
4	A.O.U. Pisana Presidio Ospedaliero Cisanello	Pisa		Italy	56124
5	Azienda Sanitaria Universitaria Friuli Centrale	Udine		Italy	33100
6	ASST dei Sette Laghi	Varese		Italy
7	Hospital Universitario Fundación Alcorcón	Alcorcón	Madrid	Spain	28922
8	Hospital Clinic	Barcelona		Spain	08036
9	Hospital Universitario Virgen de las Nieves	Granada		Spain	18014
10	Hospital Universitario La Paz	Madrid		Spain	28046
11	Hospital Universitario y Politécnico La Fe	Valencia		Spain	46026