A Phase 4 interventional study of Usual Care and Dalbavancin in Acute Bacterial Skin and Skin Structure Infections, sponsored by Allergan. Completed at 11 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-10.
Sponsored by Allergan · Phase 4, Interventional, and Treatment
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 313 is above the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Allergan is the lead sponsor of 499 studies on the registry; none are open to participants now.
Of its 91 completed or terminated interventional studies of FDA-regulated products, 89 (98%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
Drug: Usual Care
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.
Drug: Dalbavancin
Usual care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
Dalbavancin administered as a single IV dose of 1500 mg over 30 minutes.
Also known as: Dalvance®
Hospital Admission Rate at Initial Episode of Care
Time frame: 44 Days
Number of Total Admitted Hospital Days
Number of days during the initial hospitalization (for those initially hospitalized) and all other hospitalizations
Time frame: 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)
Time frame: 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
Time frame: 44 Days
Number of Infection-related Total Admitted Hospital Days
Time frame: 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
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
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Time frame: 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.
Time frame: Day 14
Patient Satisfaction With Care: Hospitalization
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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
Time frame: 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.
Time frame: Day 14
| Milestone | Usual Care | New Critical Pathway |
|---|---|---|
| Started | 160 | 153 |
| Completed | 121 | 128 |
| Not completed | 39 | 25 |
| Withdrew: Protocol violation | 0 | 1 |
| Withdrew: Death | 2 | 0 |
| Withdrew: Lost to follow-up | 35 | 24 |
| Withdrew: Withdrawal by subject | 2 | 0 |
| Participants | Usual Care | New Critical Pathway |
|---|---|---|
| Yes | 60 | 27 |
| No | 96 | 126 |
Number of days during the initial hospitalization (for those initially hospitalized) and all other hospitalizations
| Days | Usual Care | New Critical Pathway |
|---|---|---|
| Number of Total Admitted Hospital Days | 2.3 ± 3.74 | 1.2 ± 2.58 |
Time spent in ED in hours from triage to release (either admitted to the hospital, admitted to observation, or released to home)
| Hours | Usual Care | New Critical Pathway |
|---|---|---|
| Total Length of Stay in Emergency Department (ED) During the Initial Episode of Care | 7.7 ± 9.09 | 6.1 ± 3.94 |
Number of all major surgical interventions unexpected or expected that required operating room time
| Participants | Usual Care | New Critical Pathway |
|---|---|---|
| No Surgeries | 107 | 106 |
| Any Surgeries | 38 | 35 |
| Days | Usual Care | New Critical Pathway |
|---|---|---|
| Number of Infection-related Total Admitted Hospital Days | 2.0 ± 3.06 | 1.0 ± 2.36 |
Number of days of hospitalization during the initial hospitalization (for those initially hospitalized) and all other infection-related hospitalizations
| Participants | Usual Care | New Critical Pathway |
|---|---|---|
| None | 85 | 110 |
| Any | 60 | 31 |
| Participants | Usual Care | New Critical Pathway |
|---|---|---|
| Admission to ICU | 3 | 0 |
| Participants | Usual Care | New Critical Pathway |
|---|---|---|
| Number of Participants With All Cause Hospitalizations in the 30 Days Post Discharge From the Hospital or Release From the ED | 7 | 12 |
| Participants | Usual Care | New Critical Pathway |
|---|---|---|
| Number of Participants With Infection-related Emergency Department (ED) Visits | 22 | 19 |
| Participants | Usual Care | New Critical Pathway |
|---|---|---|
| Number of Participants With Infection-related Outpatient Healthcare Visits | 57 | 39 |
| Participants | Usual Care | New Critical Pathway |
|---|---|---|
| Peripheral IV | 93 | 141 |
| Central line | 0 | 0 |
| PICC line | 1 | 1 |
| No Line | 143 | 136 |
| Participants | Usual Care | New Critical Pathway |
|---|---|---|
| 1 occurence | 2 | 1 |
| Participants | Usual Care | New Critical Pathway |
|---|---|---|
| Number of Participants With Serious Adverse Events (SAEs) | 11 | 16 |
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
| Participants | Usual Care | New Critical Pathway |
|---|---|---|
| Excellent | 12 | 22 |
| Very good | 38 | 31 |
| Good | 35 | 40 |
| Fair | 30 | 23 |
| Poor | 4 | 8 |
Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.
| scores on a scale | Usual Care | New Critical Pathway |
|---|---|---|
| Patient Satisfaction With Care: Wait in Emergency Room | 7.8 ± 2.63 | 8.3 ± 2.25 |
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
| Participants | Usual Care | New Critical Pathway |
|---|---|---|
| Yes | 63 | 27 |
| No | 56 | 97 |
Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.
| Scores on a Scale | Usual Care | New Critical Pathway |
|---|---|---|
| Patient Satisfaction With Care: Satisfaction With Hospital Stay | 8.2 ± 2.19 | 8.0 ± 1.85 |
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
| Participant | Usual Care | New Critical Pathway |
|---|---|---|
| Hospital stay interfered with work/school | 11 | 8 |
| Stay got in way of daily normal activities | 11 | 10 |
| Stay got in the way of providing care to others | 8 | 8 |
| Hospital stay was expensive | 2 | 6 |
| Did not provide adequate monitoring by providers | 3 | 1 |
| Did not provide well trained healthcare providers | 3 | 0 |
| Hospital stay made me feel worse | 3 | 0 |
| Hospital stay made me feel concerned | 14 | 7 |
| Hospital stay was uncomfortable | 11 | 5 |
| Hospital stay disrupted my sleep | 12 | 6 |
| Other | 7 | 2 |
| I was not dissatisfied with my hospital stay | 33 | 12 |
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
| Participants | Usual Care | New Critical Pathway |
|---|---|---|
| Yes | 87 | 119 |
| No | 32 | 5 |
Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.
| Scores on a Scale | Usual Care | New Critical Pathway |
|---|---|---|
| Patient Satisfaction With Care: Satisfaction With Receiving IV Antibiotic Therapy | 8.7 ± 2.16 | 9.0 ± 1.63 |
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
| Participants | Usual Care | New Critical Pathway |
|---|---|---|
| Allowed me to return to work/school | 37 | 50 |
| Allowed me to return to daily normal activities | 48 | 81 |
| Allowed me to return to providing care to others | 38 | 52 |
| IV antibiotic therapy was affordable | 29 | 45 |
| Administered at appointments that I could schedule | 4 | 11 |
| Administered quickly once arrived at appt | 4 | 17 |
| Administered at setting that had convenient hours | 3 | 16 |
| Ensured regular monitoring by healthcare providers | 26 | 29 |
| Administered by skilled healthcare providers | 51 | 58 |
| IV antibiotic therapy made me feel better | 55 | 80 |
| Allowed to receive care for skin infection at home | 4 | 10 |
| Convenient to administer by self/caregiver at home | 2 | 4 |
| Other | 4 | 8 |
| Not satisfied with receiving IV antibiotic therapy | 9 | 3 |
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
| Participants | Usual Care | New Critical Pathway |
|---|---|---|
| Got in the way of work/school | 2 | 1 |
| Got in way of performing daily normal activities | 3 | 4 |
| Got in the way of providing care to others | 1 | 1 |
| IV antibiotic therapy was expensive | 0 | 0 |
| Required me to make appointments | 1 | 0 |
| Administered at healthcare setting w/limited hours | 1 | 0 |
| Required traveling to and from appointments | 0 | 0 |
| Required to wait to be seen by provider | 1 | 2 |
| IV antibiotic therapy took too long to administer | 1 | 3 |
| Required having a PICC or central line inserted | 2 | 2 |
| Caused an IV site infection | 0 | 0 |
| IV antibiotic therapy made me feel worse | 2 | 2 |
| Not adequately monitored by healthcare providers | 1 | 0 |
| Not administered by skilled healthcare providers | 1 | 0 |
| IV antibiotic therapy made me feel concerned | 2 | 2 |
| Required a nurse/healthcare worker coming to home | 0 | 0 |
| Required administration to self/caregiver at home | 0 | 0 |
| Other | 4 | 1 |
| Not dissatisfied w/receiving IV antibiotic therapy | 72 | 105 |
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
| Participants | Usual Care | New Critical Pathway |
|---|---|---|
| None of the time | 66 | 94 |
| A little of the time | 6 | 10 |
| Some of the time | 6 | 11 |
| Most of the time | 5 | 1 |
| All of the time | 4 | 2 |
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
| Participants | Usual Care | New Critical Pathway |
|---|---|---|
| None of the time | 62 | 80 |
| A little of the time | 8 | 19 |
| Some of the time | 8 | 12 |
| Most of the time | 5 | 3 |
| All of the time | 4 | 4 |
Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.
| Scores on a scale | Usual Care | New Critical Pathway |
|---|---|---|
| Patient Satisfaction With Care: Satisfied With the Number of IV Infusions Received Per Day | 8.4 ± 2.36 | 9.0 ± 1.70 |
Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.
| Scores on a Scale | Usual Care | New Critical Pathway |
|---|---|---|
| Patient Satisfaction With Care: Satisfaction With the Average Time to Administer Each IV | 8.6 ± 1.87 | 8.8 ± 1.88 |
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
| Participants | Usual Care | New Critical Pathway |
|---|---|---|
| Less than 15 minutes | 7 | 19 |
| 16 - 30 minutes | 5 | 17 |
| 31 - 60 minutes | 2 | 4 |
| 61 - 90 minutes | 1 | 1 |
| More than 90 minutes | 2 | 0 |
| I did not need to travel to my appointments | 68 | 77 |
| I don't remember | 1 | 0 |
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
| Participants | Usual Care | New Critical Pathway |
|---|---|---|
| Less than 15 minutes | 4 | 17 |
| 16 - 30 minutes | 7 | 10 |
| 31 - 60 minutes | 3 | 4 |
| 61 - 90 minutes | 3 | 2 |
| More than 90 minutes | 2 | 8 |
| I did not need to wait for my appointments | 67 | 75 |
| I don't remember | 0 | 2 |
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
| Participants | Usual Care | New Critical Pathway |
|---|---|---|
| Overnight hospital stay for one or more nights | 42 | 17 |
| Outpatient care: Brief hospital visit w/no stay | 74 | 106 |
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
| Participants | Usual Care | New Critical Pathway |
|---|---|---|
| To avoid hospital stay for 1 or more nights | 52 | 91 |
| To allow me to return to work/school | 37 | 44 |
| To return to performing daily normal living | 48 | 65 |
| To allow me to return to providing care to others | 27 | 36 |
| Outpatient care would be more affordable | 21 | 38 |
| Outpatient care would be more convenient | 43 | 64 |
| To ensure monitoring by healthcare providers | 10 | 22 |
| Administered by skilled healthcare providers | 17 | 27 |
| Other | 3 | 1 |
| I would not prefer outpatient care | 38 | 14 |
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
| Participants | Usual Care | New Critical Pathway |
|---|---|---|
| Regimen 1 | 65 | 107 |
| Regimen 2 | 14 | 6 |
| Regimen 3 | 38 | 8 |
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
| Participants | Usual Care | New Critical Pathway |
|---|---|---|
| About 30 minutes or less | 73 | 87 |
| About 1 hour | 28 | 32 |
| About 1.5 to 2 hours | 13 | 3 |
| About 3 hours or longer | 3 | 1 |
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
| Participants | Usual Care | New Critical Pathway |
|---|---|---|
| Definitely not | 13 | 5 |
| Probably not | 13 | 8 |
| Probably so | 38 | 37 |
| Definitely so | 51 | 73 |
Number of days with lost/reduced productivity during follow-up, as measured with Work Productivity and Activity Impairment (WPAI) Questionnaire
| Percentage | Usual Care | New Critical Pathway |
|---|---|---|
| Absenteeism | 17.4 ± 31.96 | 18.9 ± 33.49 |
| Impairment while working | 14.5 ± 24.14 | 10.8 ± 22.30 |
| Overall work impairment | 21.3 ± 29.04 | 16.4 ± 26.82 |
| Activity impairment | 24.2 ± 34.06 | 15.9 ± 28.88 |
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.
| Score on a Scale | Usual Care | New Critical Pathway |
|---|---|---|
| Mental Health Component Score | 51.2 ± 10.36 | 52.6 ± 9.63 |
| Physical Health Component Score | 46.4 ± 10.36 | 47.8 ± 9.39 |
Collected over Adverse events were collected up to 44 days. Initial care is the date of enrollment to 10-14 days and follow-up is 30 days after initial care.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Usual Care | 2/156 (1.3%) | 11/156 (7.1%) | 4/156 (2.6%) |
| New Critical Pathway | 2/153 (1.3%) | 16/153 (10.5%) | 16/153 (10.5%) |
| Event | Usual Care | New Critical Pathway |
|---|---|---|
| CELLULITISInfections and infestations | 2/156 | 8/153 |
| SKIN INFECTIONInfections and infestations | 2/156 | 0/153 |
| TREATMENT FAILUREGeneral disorders | 2/156 | 0/153 |
| ABSCESSInfections and infestations | 0/156 | 1/153 |
| BACTERAEMIAInfections and infestations | 0/156 | 1/153 |
| CLOSTRIDIUM DIFFICILE COLITISInfections and infestations | 0/156 | 1/153 |
| LYMPHANGITISInfections and infestations | 0/156 | 1/153 |
| SKIN BACTERIAL INFECTIONInfections and infestations | 0/156 | 1/153 |
| SUBCUTANEOUS ABSCESSInfections and infestations | 0/156 | 1/153 |
| PULMONARY EMBOLISMRespiratory, thoracic and mediastinal disorders | 0/156 | 1/153 |
| Event | Usual Care | New Critical Pathway |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 2/156 | 8/153 |
| CellulitisInfections and infestations | 2/156 | 8/153 |
Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion.
| Age, Customized(Participants) | Usual Care | New Critical Pathway | Total |
|---|---|---|---|
| <20 years | 1 | 2 | 3 |
| 20-29 years | 28 | 14 | 42 |
| 30-39 years | 31 | 40 | 71 |
| 40-49 years | 25 | 29 | 54 |
| 50-59 years | 37 | 31 | 68 |
| 60-69 years | 22 | 24 | 46 |
| 70-79 years | 8 | 9 | 17 |
| 80-89 years | 3 | 3 | 6 |
| 90-98 years | 1 | 1 | 2 |
| Sex: Female, Male(Participants) | Usual Care | New Critical Pathway | Total |
|---|---|---|---|
| Female | 56 | 54 | 110 |
| Male | 100 | 99 | 199 |
| Ethnicity (NIH/OMB)(Participants) | Usual Care | New Critical Pathway | Total |
|---|---|---|---|
| Hispanic or Latino | 39 | 43 | 82 |
| Not Hispanic or Latino | 116 | 107 | 223 |
| Unknown or Not Reported | 1 | 3 | 4 |
| Race/Ethnicity, Customized(Participants) | Usual Care | New Critical Pathway | Total |
|---|---|---|---|
| White or Caucasian | 89 | 91 | 180 |
| Black or African American | 30 | 39 | 69 |
| American Indian or Alaska Native | 6 | 2 | 8 |
| Asian | 1 | 2 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Other | 17 | 16 | 33 |
| Patient chose not to answer | 13 | 3 | 16 |
Documents are hosted by the registry — open the source record to download them.
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