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DiabetesDALBADIANCT04959799

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

An observational study of Diabetes and Infection, run by Aziende Chimiche Riunite Angelini Francesco S.p.A at 11 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes, Infection
What is being tested?
Dalbavancin
How many people
98 participants
Where
11 sitesin 2 countries
Study dates
2 Jan 2022to 31 May 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

11 sites in 2 countries.

11 sites in 2 countries

Italy6 sites

  • Ospedale Cardinal Massaia

    Asti, 14100

  • Azienda Ospedaliera Universitaria Federico II

    Naples, 80131

  • Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone"

    Palermo, 90127

  • A.O.U. Pisana Presidio Ospedaliero Cisanello

    Pisa, 56124

  • Azienda Sanitaria Universitaria Friuli Centrale

    Udine, 33100

  • ASST dei Sette Laghi

    Varese

Other trials in Italy

Spain5 sites

  • Hospital Universitario Fundación Alcorcón

    Alcorcón, Madrid, 28922

  • Hospital Clinic

    Barcelona, 08036

  • Hospital Universitario Virgen de las Nieves

    Granada, 18014

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario y Politécnico La Fe

    Valencia, 46026

Other trials in Spain

About this study

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

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.

Read the 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.

Conditions
Diabetes, Infection
Being tested
Dalbavancin
Keywords
Diabetes, ABSSSI, Infection, Gram-positive bacteria, Dalbavancin
Medical subject headings
Diabetes Mellitus, Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DalbavancinDrug

    Also called Xydalba

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 4 weeks

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

    Evidence of dalbavancin treatment choice (starting and subsequent dosage)

    Measured: 4 weeks

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

    Evidence of dalbavancin treatment choice (setting of infusion)

    Measured: 4 weeks

Secondary outcomes (4)

  1. Demographic data

    Demographic data description (Age and Gender)

    Measured: 4 weeks

  2. 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.

    Measured: Up to 8 weeks

  3. 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

    Measured: Up to 8 weeks

  4. Incidence of Adverse Events

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

    Measured: Up to 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2021
  2. Study start2 Jan 2022
  3. Primary completion31 May 2022
  4. Study completion31 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
98 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04959799
Sponsor's protocol ID
146(Z)PO20094
Acronym
DALBADIA
Status last verified
Sep 2022
First submitted
21 Jun 2021
Last updated
21 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 38211660

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes and Infection, run by Aziende Chimiche Riunite Angelini Francesco S.p.A at 11 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Italy, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Retrospective description of the dalbavancin treatment in diabetic patients. (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04959799, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2022.

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