Bacterial InfectionsPhase 4NCT03233438
Development 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 Bacterial Infections and Acute Bacterial Skin and Skin Structure Infection, run by Allergan at 1 site in United States.
Trial summary
The purpose of this study is to assess the effect of a new critical pathway (use of guideline-based patient identification criteria and for those who meet these criteria, use of dalbavancin) compared to usual care for the treatment of ABSSI (Acute Bacterial Skin and Skin Structure Infections) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacterial Infections, Acute Bacterial Skin and Skin Structure Infection
- 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
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2017to 30 Oct 2018
- 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
- Admitted patients who 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
1 site in 1 country.
About this study
Official title: Development of a New Critical Pathway for Treatment of Acute Bacterial Skin and Skin Structure Infections
The purpose of this study is to assess the effect of a new critical pathway (use of guideline-based patient identification criteria and for those who meet these criteria, use of dalbavancin) compared to usual care for the treatment of ABSSI (Acute Bacterial Skin and Skin Structure Infections)
- Being tested
- Dalbavancin, Usual Care
- 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
- Bacterial Infections, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DalbavancinDrug
Also called Dalvance®
Dalbavancin administered as a single IV dose of 1500 mg over 30 minutes.
Usual CareDrug
Usual care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Infection-related Total Admitted Hospital Days
Measured: 44 Days
Secondary outcomes (30)
Number of Total Admitted Hospital Days
Measured: 44 Days
Number of Participants With Infection-related Major Surgical Interventions That Required Operating Room Time
Measured: 44 Days
Number of Participants With Infection-related Hospitalizations
Measured: 44 Days
Number of Participants With Infection-related Hospitalizations 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
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
Change From Baseline in Response to Treatment at End of Treatment Visit
Response to treatment (healthcare provider assessment) comparing response at the Day 14 visit. Response to treatment will be defined through an assessment of erythema (measurement of lesion characteristics) and the absence of fever
Measured: Baseline, Day 14
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: 14 Days
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: 14 Days
Patient Satisfaction With Care: Hospitalization
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Measured: 14 Days
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: 14 Days
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: 14 Days
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: 14 Days
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: 14 Days
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: 14 Days
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: 14 Days
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: 14 Days
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: 14 Days
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: 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: 14 Days
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: 14 Days
Patient Satisfaction With Care: Find Value in a Physician
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Measured: 14 Days
Patient Work and Productivity Loss as Assessed Through the Work Productivity and Activity Impairment Questionnaire
Measured: Day 10-14
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
Healthcare Costs
Cost of hospital inpatient stays, ED visits, healthcare visits, procedures, and biological tests
Measured: 44 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2017
- Study start24 Jul 2017
- Primary completion30 Oct 2018
- Study completion30 Oct 2018
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 Bacterial 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
- 91 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
- NCT03233438
- Sponsor's protocol ID
- CMO-US-ID-0528
- Status last verified
- Jan 2020
- First submitted
- 26 Jul 2017
- Last updated
- 18 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
McCarthy MW, Keyloun KR, Gillard P, Choi JJ, Pickell N, Copp R, Walsh TJ. Dalbavancin Reduces Hospital Stay and Improves Productivity for Patients with Acute Bacterial Skin and Skin Structure Infections: The ENHANCE Trial. Infect Dis Ther. 2020 Mar;9(1):53-67. doi: 10.1007/s40121-019-00275-4. Epub 2019 Nov 11.
PubMed 31713130
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a New Critical Pathway for Treatment of Acute Bacterial Skin and Skin Structure Infections
- ClinicalTrials.gov ID
- NCT03233438
- Acronym / sponsor ID
- CMO-US-ID-0528
- 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
- 91 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 24 Jul 2017 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 28 Jul 2017 (actual)
- Results
- Posted 18 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the effect of a new critical pathway (use of guideline-based patient identification criteria and for those who meet these criteria, use of dalbavancin) compared to usual care for the treatment of ABSSI (Acute Bacterial Skin and Skin Structure Infections)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Admitted patients who 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 |
|---|---|---|
| DalbavancinAlso: Dalvance®Dalbavancin administered as a single IV dose of 1500 mg over 30 minutes. | Drug | New Critical Pathway |
| Usual CareUsual care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI. | Drug | Usual Care |
Primary outcome
Number of Infection-related Total Admitted Hospital Days
Time frame: 44 Days
30 secondary outcomes
Number of Total Admitted Hospital Days
Time frame: 44 Days
Number of Participants With Infection-related Major Surgical Interventions That Required Operating Room Time
Time frame: 44 Days
Number of Participants With Infection-related Hospitalizations
Time frame: 44 Days
Number of Participants With Infection-related Hospitalizations 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
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
Change From Baseline in Response to Treatment at End of Treatment Visit
Time frame: Baseline, Day 14
Number of Participants With Serious Adverse Events (SAEs)
Time frame: 44 Days
Patient Satisfaction With Care: Overall Health
Time frame: 14 Days
Patient Satisfaction With Care: Wait in Emergency Room
Time frame: 14 Days
Patient Satisfaction With Care: Hospitalization
Time frame: 14 Days
Patient Satisfaction With Care: Satisfaction With Hospital Stay
Time frame: 14 Days
Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay
Time frame: 14 Days
Patient Satisfaction With Care: Received IV Antibiotic Therapy for Skin Infections
Time frame: 14 Days
Patient Satisfaction With Care: Satisfaction With Receiving IV Antibiotic Therapy
Time frame: 14 Days
Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV
Time frame: 14 Days
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: 14 Days
Patient Satisfaction With Care: Concerned About Receiving Your IV Therapy
Time frame: 14 Days
Patient Satisfaction With Care: Satisfied With the Number of IV Infusions Received Per Day
Time frame: 14 Days
Patient Satisfaction With Care: Satisfaction With the Average Time to Administer Each IV
Time frame: 14 Days
Patient Satisfaction With Care: Regimen Preferred if Treated Again for a Similar Skin Infection With IV
Time frame: 14 Days
Patient Satisfaction With Care: Time Willing to Spend Receiving Each IV
Time frame: 14 Days
Patient Satisfaction With Care: Find Value in a Physician
Time frame: 14 Days
Patient Work and Productivity Loss as Assessed Through the Work Productivity and Activity Impairment Questionnaire
Time frame: Day 10-14
Patient Health-related Quality of Life (HRQoL) Assessed by the Short Form 12 (SF-12) 12-Item Patient Questionnaire
Time frame: Day 14
Healthcare Costs
Time frame: 44 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31713130McCarthy MW, Keyloun KR, Gillard P, Choi JJ, Pickell N, Copp R, Walsh TJ. Dalbavancin Reduces Hospital Stay and Improves Productivity for Patients with Acute Bacterial Skin and Skin Structure Infections: The ENHANCE Trial. Infect Dis Ther. 2020 Mar;9(1):53-67. doi: 10.1007/s40121-019-00275-4. Epub 2019 Nov 11.
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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
1 site 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 Bacterial Infections and Acute Bacterial Skin and Skin Structure Infection, run by Allergan at 1 site 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 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 18 Jan 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?
Number of Infection-related Total Admitted Hospital Days (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 NCT03233438, 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 18 Jan 2020.