Acute Bacterial Skin and Skin Structure InfectionsPhase 4NCT02961764
Evaluation of a New Critical Pathway for Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
A Phase 4 study testing Dalbavancin in people with Acute Bacterial Skin and Skin Structure Infections, run by Allergan at 11 sites in United States.
Trial summary
This study will evaluate a new critical pathway (use of guideline-based patient identification criteria and for those who meet these criteria, use of dalbavancin) for the treatment of ABSSSI compared to usual care. 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 Infections
- What is being tested?
- Dalbavancin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 313 participants
- Where
- 11 sitesUnited States
- Study dates
- 29 Nov 2016to 29 Mar 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Presents to the Emergency Department (ED) and meets the clinical definition for Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
- Known or suspected gram-positive infection.
Who cannot join
- Known or suspected gram-negative infections, anaerobic infections, or fungemia
- Known or suspected infections that are severe, life threatening or are not included in the ABSSSI Food and Drug Administration (FDA) guidance
- Injection drug users with a fever
- Severe neurological disorder leading to immobility or confined to a wheelchair
- Bilateral Lower extremity involvement of the suspected infection.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Rush University Medical Center
Chicago, Illinois, 60612
Henry Ford Hospital
Detroit, Michigan, 48202
Wayne State University
Detroit, Michigan, 48202
Hartford Hospital
Hartford, Connecticut, 06102
Truman Medical Centers
Kansas City, Missouri, 64108
ProMedica Monroe Regional Hospital
Monroe, Michigan, 48162
Maricopa Medical Center
Phoenix, Arizona, 85008
Olive View-UCLA Medical Center
Sylmar, California, 91342
Tampa General Hospital
Tampa, Florida, 33606
University of Massachusetts
Worcester, Massachusetts, 01655
About this study
Official title: A Pragmatic Trial Designed to Evaluate a New Critical Pathway for Treatment of Patients With Acute Bacterial Skin and Skin Structure Infections
This study will evaluate a new critical pathway (use of guideline-based patient identification criteria and for those who meet these criteria, use of dalbavancin) for the treatment of ABSSSI compared to usual care.
- Being tested
- Usual Care, Dalbavancin
- Keywords
- Critical Pathways, Health Facilities, Clinical Protocols, Patient Satisfaction, Absenteeism, Anti-Bacterial Agents, Quality of Life, Economics, Medical, Health Resources, Health resource utilization, Acute bacterial skin and skin structure infection (ABSSSI)
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual CareDrug
Usual care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
DalbavancinDrug
Also called Dalvance®
Dalbavancin administered as a single IV dose of 1500 mg over 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI. Receives: Drug: Usual Care |
| New Critical Pathway | Active comparator | The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI. Receives: Drug: Dalbavancin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Admission Rate at Initial Episode of Care
Measured: 44 Days
Secondary outcomes (34)
Number of Total Admitted Hospital Days
Number of days during the initial hospitalization (for those initially hospitalized) and all other hospitalizations
Measured: 44 Days
Total Length of Stay in Emergency Department (ED) During the Initial Episode of Care
Time spent in ED in hours from triage to release (either admitted to the hospital, admitted to observation, or released to home)
Measured: Initial Care: 14 Days
Number of Participants With Infection-related Major Surgical Interventions That Required Operating Room Time
Number of all major surgical interventions unexpected or expected that required operating room time
Measured: 44 Days
Number of Infection-related Total Admitted Hospital Days
Measured: 44 Days
Number of Participants With Infection-related Hospitalizations
Number of days of hospitalization during the initial hospitalization (for those initially hospitalized) and all other infection-related hospitalizations
Measured: 44 Days
Number of Participants With Infection-related Hospitalizations During Initial Care and Follow-up That Resulted in Admission to Intensive Care Unit
Measured: 44 Days
Number of Participants With All Cause Hospitalizations in the 30 Days Post Discharge From the Hospital or Release From the ED
Measured: Follow-up: 30 Days
Number of Participants With Infection-related Emergency Department (ED) Visits
Measured: 44 Days
Number of Participants With Infection-related Outpatient Healthcare Visits
Measured: 44 Days
Use of a Peripherally-Inserted Central Catheter (PICC) Line or Central Line to Administer Antibiotic Therapy
Measured: 44 Days
Number of Participants With Infection-related Healthcare Visits Due to PICC Line or Central Line Used to Administer Antibiotic Therapy
Measured: 44 Days
Number of Participants With Serious Adverse Events (SAEs)
Measured: 44 Days
Patient Satisfaction With Care: Overall Health
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Measured: Day 14
Patient Satisfaction With Care: Wait in Emergency Room
Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.
Measured: Day 14
Patient Satisfaction With Care: Hospitalization
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Measured: Day 14
Patient Satisfaction With Care: Satisfaction With Hospital Stay
Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.
Measured: Day 14
Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Measured: Day 14
Patient Satisfaction With Care: Received IV Antibiotic Therapy for Skin Infections
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Measured: Day 14
Patient Satisfaction With Care: Satisfaction With Receiving IV Antibiotic Therapy
Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.
Measured: Day 14
Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Measured: Day 14
Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Measured: 14 Days
Patient Satisfaction With Care: IV Therapy Hindering Normal Activities of Daily Living
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Measured: Day 14
Patient Satisfaction With Care: Concerned About Receiving Your IV Therapy
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Measured: Day 14
Patient Satisfaction With Care: Satisfied With the Number of IV Infusions Received Per Day
Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.
Measured: Day 14
Patient Satisfaction With Care: Satisfaction With the Average Time to Administer Each IV
Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.
Measured: Day 14
Patient Satisfaction With Care: Time to Travel to Appointments to Receive IV
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Measured: 14 days
Patient Satisfaction With Care: Average Time to be Seen by a Healthcare Provider
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Measured: 14 days
Patient Satisfaction With Care: Healthcare Setting Preferred if Treated Again for a Skin Infection With IV
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Measured: 14 Days
Patient Satisfaction With Care: Factors Contributing to Preference for Outpatient Care
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Measured: 14 Days
Patient Satisfaction With Care: Regimen Preferred if Treated Again for a Similar Skin Infection With IV
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Measured: Day 14
Patient Satisfaction With Care: Time Willing to Spend Receiving Each IV
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Measured: Day 14
Patient Satisfaction With Care: Find Value in a Physician
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Measured: Day 14
Patient Work and Productivity Loss as Assessed Through the Work Productivity and Activity Impairment Questionnaire
Number of days with lost/reduced productivity during follow-up, as measured with Work Productivity and Activity Impairment (WPAI) Questionnaire
Measured: Day 14
Patient Health-related Quality of Life (HRQoL) Assessed by the Short Form 12 (SF-12) 12-Item Patient Questionnaire
The SF-12 yields a physical and a mental health component summary score (referred to as physical component summary score [PCS] and mental component summary score [MCS]). The PCS and MCS follow a t-score distribution, i.e. mean of 50 and standard deviation of 10 in the general US population, meaning all scores above or below 50 are above and below the average, respectively, in the US general population.
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2016 (estimated)
- Study start29 Nov 2016
- Primary completion29 Mar 2019
- Study completion29 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Bacterial Skin and Skin Structure InfectionsStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 313 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrick Gillard, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02961764
- Sponsor's protocol ID
- CMO-US-ID-0476
- Status last verified
- Mar 2020
- First submitted
- 7 Nov 2016
- Last updated
- 10 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Talan DA, Mower WR, Lovecchio FA, Rothman RE, Steele MT, Keyloun K, Gillard P, Copp R, Moran GJ. Pathway with single-dose long-acting intravenous antibiotic reduces emergency department hospitalizations of patients with skin infections. Acad Emerg Med. 2021 Oct;28(10):1108-1117. doi: 10.1111/acem.14258. Epub 2021 May 5.
PubMed 33780567
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic Trial Designed to Evaluate a New Critical Pathway for Treatment of Patients With Acute Bacterial Skin and Skin Structure Infections
- ClinicalTrials.gov ID
- NCT02961764
- Acronym / sponsor ID
- CMO-US-ID-0476
- Keywords
- Critical Pathways, Health Facilities, Clinical Protocols, Patient Satisfaction, Absenteeism, Anti-Bacterial Agents, Quality of Life, Economics, Medical
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 313 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 29 Nov 2016 (actual)
- Primary completion
- 29 Mar 2019 (actual)
- Study completion
- 29 Mar 2019 (actual)
- First posted
- 11 Nov 2016 (estimated)
- Results
- Posted 10 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate a new critical pathway (use of guideline-based patient identification criteria and for those who meet these criteria, use of dalbavancin) for the treatment of ABSSSI compared to usual care.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Drug: Usual CareParticipants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI. |
| New Critical Pathway | Active comparator | Drug: DalbavancinThe New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Presents to the Emergency Department (ED) and meets the clinical definition for Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
- Known or suspected gram-positive infection.
Key exclusion criteria (5 listed)
- Known or suspected gram-negative infections, anaerobic infections, or fungemia
- Known or suspected infections that are severe, life threatening or are not included in the ABSSSI Food and Drug Administration (FDA) guidance
- Injection drug users with a fever
- Severe neurological disorder leading to immobility or confined to a wheelchair
- Bilateral Lower extremity involvement of the suspected infection.
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 |
|---|---|---|
| Usual CareUsual care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI. | Drug | Usual Care |
| DalbavancinAlso: Dalvance®Dalbavancin administered as a single IV dose of 1500 mg over 30 minutes. | Drug | New Critical Pathway |
Primary outcome
Hospital Admission Rate at Initial Episode of Care
Time frame: 44 Days
34 secondary outcomes
Number of Total Admitted Hospital Days
Time frame: 44 Days
Total Length of Stay in Emergency Department (ED) During the Initial Episode of Care
Time frame: Initial Care: 14 Days
Number of Participants With Infection-related Major Surgical Interventions That Required Operating Room Time
Time frame: 44 Days
Number of Infection-related Total Admitted Hospital Days
Time frame: 44 Days
Number of Participants With Infection-related Hospitalizations
Time frame: 44 Days
Number of Participants With Infection-related Hospitalizations During Initial Care and Follow-up That Resulted in Admission to Intensive Care Unit
Time frame: 44 Days
Number of Participants With All Cause Hospitalizations in the 30 Days Post Discharge From the Hospital or Release From the ED
Time frame: Follow-up: 30 Days
Number of Participants With Infection-related Emergency Department (ED) Visits
Time frame: 44 Days
Number of Participants With Infection-related Outpatient Healthcare Visits
Time frame: 44 Days
Use of a Peripherally-Inserted Central Catheter (PICC) Line or Central Line to Administer Antibiotic Therapy
Time frame: 44 Days
Number of Participants With Infection-related Healthcare Visits Due to PICC Line or Central Line Used to Administer Antibiotic Therapy
Time frame: 44 Days
Number of Participants With Serious Adverse Events (SAEs)
Time frame: 44 Days
Patient Satisfaction With Care: Overall Health
Time frame: Day 14
Patient Satisfaction With Care: Wait in Emergency Room
Time frame: Day 14
Patient Satisfaction With Care: Hospitalization
Time frame: Day 14
Patient Satisfaction With Care: Satisfaction With Hospital Stay
Time frame: Day 14
Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay
Time frame: Day 14
Patient Satisfaction With Care: Received IV Antibiotic Therapy for Skin Infections
Time frame: Day 14
Patient Satisfaction With Care: Satisfaction With Receiving IV Antibiotic Therapy
Time frame: Day 14
Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV
Time frame: Day 14
Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV
Time frame: 14 Days
Patient Satisfaction With Care: IV Therapy Hindering Normal Activities of Daily Living
Time frame: Day 14
Patient Satisfaction With Care: Concerned About Receiving Your IV Therapy
Time frame: Day 14
Patient Satisfaction With Care: Satisfied With the Number of IV Infusions Received Per Day
Time frame: Day 14
Patient Satisfaction With Care: Satisfaction With the Average Time to Administer Each IV
Time frame: Day 14
Patient Satisfaction With Care: Time to Travel to Appointments to Receive IV
Time frame: 14 days
Patient Satisfaction With Care: Average Time to be Seen by a Healthcare Provider
Time frame: 14 days
Patient Satisfaction With Care: Healthcare Setting Preferred if Treated Again for a Skin Infection With IV
Time frame: 14 Days
Patient Satisfaction With Care: Factors Contributing to Preference for Outpatient Care
Time frame: 14 Days
Patient Satisfaction With Care: Regimen Preferred if Treated Again for a Similar Skin Infection With IV
Time frame: Day 14
Patient Satisfaction With Care: Time Willing to Spend Receiving Each IV
Time frame: Day 14
Patient Satisfaction With Care: Find Value in a Physician
Time frame: Day 14
Patient Work and Productivity Loss as Assessed Through the Work Productivity and Activity Impairment Questionnaire
Time frame: Day 14
Patient Health-related Quality of Life (HRQoL) Assessed by the Short Form 12 (SF-12) 12-Item Patient Questionnaire
Time frame: Day 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33780567Talan DA, Mower WR, Lovecchio FA, Rothman RE, Steele MT, Keyloun K, Gillard P, Copp R, Moran GJ. Pathway with single-dose long-acting intravenous antibiotic reduces emergency department hospitalizations of patients with skin infections. Acad Emerg Med. 2021 Oct;28(10):1108-1117. doi: 10.1111/acem.14258. Epub 2021 May 5.
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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.
Patrick Gillard study director
Allergan
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dalbavancin in people with Acute Bacterial Skin and Skin Structure Infections, run by Allergan at 11 sites in United States.
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 2 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 10 Apr 2020. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Hospital Admission Rate at Initial Episode of Care (time frame: 44 Days). 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 NCT02961764, 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 10 Apr 2020.