Acute Bacterial Skin and Skin Structure InfectionREDSNCT04298463
Retrospective Effectiveness Study of Dalbavancin and Other Standard of Care of the Same Class in Patients With ABSSSI
An observational study of Acute Bacterial Skin and Skin Structure Infection, run by Aziende Chimiche Riunite Angelini Francesco S.p.A at 16 sites in 2 countries.
Trial summary
The aim of this study is to collect the data on the effectiveness of dalbavancin in terms of save of hospitalization days on patients treated between June 2017 and June 2019 in two countries (Italy and Greece) vs the other Standards of care of the same class (SoC; i.v. lipo and glycopeptides) in a real-life context. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Bacterial Skin and Skin Structure Infection
- What is being tested?
- Xydalba and vancomycin, teicoplanin or daptomycin
- Type of treatment
- Injection or infusion
- How many people
- 184 participants
- Where
- 16 sitesin 2 countries
- Study dates
- 18 Jun 2020to 19 May 2021
- 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: The study population will include patients hospitalized for at least 2 days with evidence of primary diagnosis of ABSSSI and treated with dalbavancin or other SoC of similar class (i.v lipo and glycopeptides vancomycin, teicoplanin or daptomycin).
Who may be able to join
- Male and female patients ≥ of 18 years old
- Patients hospitalized for at least 2 days with evidence of primary diagnosis of ABSSSI of International Classification of Diseases (ICD) 9: - 681.XX (cellulitis and abscess of finger and toe) -682.XX (other cellulitis and abscess) - 958.3X (post-traumatic wound infection not elsewhere classified) - 998.5X (postoperative infection not elsewhere classified); and corresponding code for ICD 10; and/or Diagnosis-related group (DRG) 277; 278; 418 (for Italy), for cellulitis/erysipelas, wound infection, major cutaneous abscess.
- Patients treated with dalbavancin or other SoC of the same or similar class (i.v. lipo and glycopeptides: teicoplanin, vancomycin, daptomycin) according to summary of product characteristics (SmPC).
- Patients treated with or without other chemotherapy to cover Gram- bacteria or fungals.
- Patients who gave their consent for personal data processing according to the local regulation.
Who cannot join
- Patients with infected wound or ulcer (neoplastic, inflammatory and autoimmune ulcers), animal bite
- Patients with ulcer not colonized, discolored, odorous, pressure ulcer grade I, II, III, or IV (according to NPUAP classification - Appendix A)
- Patients with arteriopathies
- Patients presenting or who have presented in the last 30 days before the hospitalization the following infections:
- diabetic foot infection (ICD9= 707.15; 249.8)
- suspected or confirmed osteomyelitis (ICD9= 730.xx)
Show all 14Show fewer
- suspected or confirmed septic arthritis (ICD9= 711.00)
- infective endocarditis (ICD9=421.0)
- meningitis (ICD9=322.xx)
- joint infection (ICD9= 711.00)
- necrotizing fasciitis (ICD9=728.86)
- gangrene (ICD9=785.4)
- prosthetic joint infection or prosthetic implant/device infection (ICD9=996.66)
- Patient with history of neutropenia or in treatment with immunosuppressants in the last six months before the hospitalization
Trial locations and contacts
16 sites in 2 countries.
16 sites in 2 countries
Italy12 sites
AO Sant'Orsola Malpighi Unità Operativa di Malattie Infettive
Bologna, 40138
Azienda Ospedaliera per l'Emergenza Cannizzaro Unità Operativa Complessa di Malattie Infettive
Catania, 95126
A.O.U. Careggi SOD Malattie Infettive e Tropicali
Florence, 50134
Ospedale Policlinico San Martino - IRCCS Genova Clinica Malattie Infettive
Genova, 16132
ASST MANTOVA Ospedale Carlo Poma di Mantova S.C. Malattie Infettive
Mantua, 46100
A.S.S.T. GRANDE OSPEDALE METROPOLITANO NIGUARDA S.C. Malattie Infettive Dipartimento Medico Polispecialistico
Milan, 20162
AOU Federico II di Napoli Dipartimento di Medicina clinica e Chirurgia UOC Malattie Infettive
Naples, 80131
Azienda Ospedaliera di Padova U.O.C. Malattie Infettive e Tropicali
Padova, 35128
Ospedale S. Maria della Misericordia Clinica Malattie Infettive Dipartimento di Medicina, Università Studi di Perugia
Perugia, 06156
A.O.U. Pisana Stabilimento di Cisanello U.O Malattie Infettive
Pisa, 56124
A.O.R. San Carlo Struttura Interaziendale Complessa di Malattie Infettive
Potenza, 85100
AOU Città della Salute e Scienza - Presidio Molinette SC Malattie Infettive
Torino, 10126
Greece4 sites
University Hospital of Alexandroupolis
Alexandroupoli, 68100
Attikon University Hospital, Rimini 1, Chaidari, 124 62
Athens, 12462
University Hospital of Heraklion
Heraklion, 71110
University General Hospital of Thessaloniki AHEPA /
Thessaloniki, 54621
About this study
Official title: Retrospective Effectiveness Study of Dalbavancin and Other Standard of Care of the Same Class (i.v. Lipo and Glyco-peptides) in Patients With ABSSSI
The aim of this study is to collect the data on the effectiveness of dalbavancin in terms of save of hospitalization days on patients treated between June 2017 and June 2019 in two countries (Italy and Greece) vs the other Standards of care of the same class (SoC; i.v. lipo and glycopeptides) in a real-life context.
Time to discharge from the start of therapy for ABSSSI in the hospital context will be assessed and all relevant data available on patient management, clinical, microbiological and safety outcomes during hospitalization and in the follow-up visits up to 30 days from discharge will be collected and evaluated.
Read the detailed description
Acute bacterial skin and skin structure infections (ABSSSI), formally referred to as complicated skin and soft tissue infections, include infections such as cellulitis/erysipelas, wound infection, and major cutaneous abscess and have a minimum lesion surface area of approximately 75 cm2. The regulatory definitions of major abscess, cellulitis, and wound infection may not align with practice-based criteria. Common bacterial pathogens causing ABSSSI are Streptococcus pyogenes and Staphylococcus aureus including Methicillin-Resistant Staphylococcus Aureus (MRSA). Less common causes include other Streptococcus species, Enterococcus faecalis, or Gram-negative bacteria.
Increasing dramatically in incidence, a challenging medical problem associated with high direct and indirect costs has been highlighted for both the medical system and society.
Over the last decade, there was a witnessed a dramatic increase in the incidence of community acquired skin infections, an increasing proportion of which are a consequence of MRSA, reinforcing the need for new and effective antibacterial therapies in this disease.
In this context, research has been promoted to develop new antibiotics capable to fight MRSA, the most common multi-drug-resistant Gram+ bacterium in Europe, and to overcome the limitations of the most widely used antibiotics, such as vancomycin, teicoplanin, and β- lactams. These new antibiotics (lipoglycopeptides and new oxazolidinones) have innovative characteristics that make them interesting for the specific treatment of ABSSSIs. Dalbavancin is one of these new antibiotics. Dalbavancin is a lipoglycopeptide with activity against Grampositive organisms, including MRSA, through interference with bacterial cell wall formation by preventing cross-linking of peptidoglycans. Dalbavancin has a distinctive pharmacokinetic profile, with a terminal half-life of 14.4 days, which allows for infrequent or even single intravenous dosing.
This new long-acting antibiotic represents a potential opportunity for early discharge. This approach could profoundly modify the management of these infections by reducing or in some cases eliminating hospitalization costs and risks.
- Being tested
- Xydalba, vancomycin, teicoplanin or daptomycin
- Keywords
- ABSSSI, skin infections, lipoglycopeptide,, Gram-positive bacteria
- Medical subject headings
- Cellulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XydalbaDrug
Drugs were administered i.v.
vancomycin, teicoplanin or daptomycinDrug
Drugs were administered i.v.
| Study group | Role | What they receive |
|---|---|---|
| COHORT A: dalbavancin | Patients hospitalized for at teast two days affected by ABSSSI and treated with dalbavancin. Receives: Drug: Xydalba | |
| COHORT B: lipo and glyco-peptid drugs | Patients hospitalized for at teast two days affected by ABSSSI and treated with vancomycin, teicoplanin or daptomycin. Receives: Drug: vancomycin, teicoplanin or daptomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of discharge from any ward of the hospital,
Time of discharge is calculated as the time elapsed from the beginning of antibiotic therapy (baseline) until discharge.
Measured: From baseline to discharge, an average of 4 weeks
Secondary outcomes (3)
Evaluation of the recorded signs and symptoms
Evaluation of local signs of inflammation.
Measured: From the hospital admission until 30 days from discharge
Microbiological evaluation
Eradication of the Gram Positive pathogens identified at baseline (MIC assessment)
Measured: From the hospital admission until 30 days from discharge
Long-term follow-up
Assessment for recurrence of ABSSSI.
Measured: 90 days from discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start18 Jun 2020
- Primary completion19 May 2021
- Study completion19 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Bacterial Skin and Skin Structure InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.A
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hippocrates Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04298463
- Sponsor's protocol ID
- 146(A)PO18530
- Acronym
- REDS
- Status last verified
- Feb 2022
- First submitted
- 10 Feb 2020
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Effectiveness Study of Dalbavancin and Other Standard of Care of the Same Class (i.v. Lipo and Glyco-peptides) in Patients With ABSSSI
- ClinicalTrials.gov ID
- NCT04298463
- Acronym / sponsor ID
- REDS / 146(A)PO18530
- Keywords
- ABSSSI, skin infections, lipoglycopeptide,, Gram-positive bacteria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.AIndustry (pharma, biotech, devices)
- Collaborators
- Hippocrates Research
- Study start
- 18 Jun 2020 (actual)
- Primary completion
- 19 May 2021 (actual)
- Study completion
- 19 May 2021 (actual)
- First posted
- 6 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to collect the data on the effectiveness of dalbavancin in terms of save of hospitalization days on patients treated between June 2017 and June 2019 in two countries (Italy and Greece) vs the other Standards of care of the same class (SoC; i.v. lipo and glycopeptides) in a real-life context.
Time to discharge from the start of therapy for ABSSSI in the hospital context will be assessed and all relevant data available on patient management, clinical, microbiological and safety outcomes during hospitalization and in the follow-up visits up to 30 days from discharge will be collected and evaluated.
Detailed description
Acute bacterial skin and skin structure infections (ABSSSI), formally referred to as complicated skin and soft tissue infections, include infections such as cellulitis/erysipelas, wound infection, and major cutaneous abscess and have a minimum lesion surface area of approximately 75 cm2. The regulatory definitions of major abscess, cellulitis, and wound infection may not align with practice-based criteria. Common bacterial pathogens causing ABSSSI are Streptococcus pyogenes and Staphylococcus aureus including Methicillin-Resistant Staphylococcus Aureus (MRSA). Less common causes include other Streptococcus species, Enterococcus faecalis, or Gram-negative bacteria.
Increasing dramatically in incidence, a challenging medical problem associated with high direct and indirect costs has been highlighted for both the medical system and society.
Over the last decade, there was a witnessed a dramatic increase in the incidence of community acquired skin infections, an increasing proportion of which are a consequence of MRSA, reinforcing the need for new and effective antibacterial therapies in this disease.
In this context, research has been promoted to develop new antibiotics capable to fight MRSA, the most common multi-drug-resistant Gram+ bacterium in Europe, and to overcome the limitations of the most widely used antibiotics, such as vancomycin, teicoplanin, and β- lactams. These new antibiotics (lipoglycopeptides and new oxazolidinones) have innovative characteristics that make them interesting for the specific treatment of ABSSSIs. Dalbavancin is one of these new antibiotics. Dalbavancin is a lipoglycopeptide with activity against Grampositive organisms, including MRSA, through interference with bacterial cell wall formation by preventing cross-linking of peptidoglycans. Dalbavancin has a distinctive pharmacokinetic profile, with a terminal half-life of 14.4 days, which allows for infrequent or even single intravenous dosing.
This new long-acting antibiotic represents a potential opportunity for early discharge. This approach could profoundly modify the management of these infections by reducing or in some cases eliminating hospitalization costs and risks.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COHORT A: dalbavancin | – | Drug: XydalbaPatients hospitalized for at teast two days affected by ABSSSI and treated with dalbavancin. |
| COHORT B: lipo and glyco-peptid drugs | – | Drug: vancomycin, teicoplanin or daptomycinPatients hospitalized for at teast two days affected by ABSSSI and treated with vancomycin, teicoplanin or daptomycin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include patients hospitalized for at least 2 days with evidence of primary diagnosis of ABSSSI and treated with dalbavancin or other SoC of similar class (i.v lipo and glycopeptides vancomycin, teicoplanin or daptomycin).
Key inclusion criteria (5 listed)
- Male and female patients ≥ of 18 years old
- Patients hospitalized for at least 2 days with evidence of primary diagnosis of ABSSSI of International Classification of Diseases (ICD) 9: - 681.XX (cellulitis and abscess of finger and toe) -682.XX (other cellulitis and abscess) - 958.3X (post-traumatic wound infection not elsewhere classified) - 998.5X (postoperative infection not elsewhere classified); and corresponding code for ICD 10; and/or Diagnosis-related group (DRG) 277; 278; 418 (for Italy), for cellulitis/erysipelas, wound infection, major cutaneous abscess.
- Patients treated with dalbavancin or other SoC of the same or similar class (i.v. lipo and glycopeptides: teicoplanin, vancomycin, daptomycin) according to summary of product characteristics (SmPC).
- Patients treated with or without other chemotherapy to cover Gram- bacteria or fungals.
- Patients who gave their consent for personal data processing according to the local regulation.
Key exclusion criteria (14 listed)
- Patients with infected wound or ulcer (neoplastic, inflammatory and autoimmune ulcers), animal bite
- Patients with ulcer not colonized, discolored, odorous, pressure ulcer grade I, II, III, or IV (according to NPUAP classification - Appendix A)
- Patients with arteriopathies
- Patients presenting or who have presented in the last 30 days before the hospitalization the following infections:
- Patient with history of neutropenia or in treatment with immunosuppressants in the last six months before the hospitalization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XydalbaDrugs were administered i.v. | Drug | COHORT A: dalbavancin |
| vancomycin, teicoplanin or daptomycinDrugs were administered i.v. | Drug | COHORT B: lipo and glyco-peptid drugs |
Primary outcome
Time of discharge from any ward of the hospital,
Time frame: From baseline to discharge, an average of 4 weeks
Time of discharge is calculated as the time elapsed from the beginning of antibiotic therapy (baseline) until discharge.
3 secondary outcomes
Evaluation of the recorded signs and symptoms
Time frame: From the hospital admission until 30 days from discharge
Microbiological evaluation
Time frame: From the hospital admission until 30 days from discharge
Long-term follow-up
Time frame: 90 days from discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Bacterial Skin and Skin Structure Infection, run by Aziende Chimiche Riunite Angelini Francesco S.p.A at 16 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 5 inclusion and 14 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 4 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Italy, Greece. 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?
Time of discharge from any ward of the hospital, (time frame: From baseline to discharge, an average of 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Mar 2022.