Phase 4
N=313
Evaluation of a New Critical Pathway for Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
Acute Bacterial Skin and Skin Structure Infections
Bottom Line
View on ClinicalTrials.gov: NCT02961764 ↗Enrolled (actual)
313
Serious AEs
8.7%
Results posted
Apr 2020
Primary outcome: Primary: Hospital Admission Rate at Initial Episode of Care — 60; 27; 96; 126 Participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Usual Care (Drug); Dalbavancin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hospital Admission Rate at Initial Episode of Care |
60; 27; 96; 126 | <0.001 sig |
| SECONDARY Number of Total Admitted Hospital Days |
2.3; 1.2 | 0.005 sig |
| SECONDARY Total Length of Stay in Emergency Department (ED) During the Initial Episode of Care |
7.7; 6.1 | 0.050 |
| SECONDARY Number of Participants With Infection-related Major Surgical Interventions That Required Operating Room Time |
107; 106; 38; 35 | — |
| SECONDARY Number of Infection-related Total Admitted Hospital Days |
2.0; 1.0 | 0.002 sig |
| SECONDARY Number of Participants With Infection-related Hospitalizations |
85; 110; 60; 31 | — |
| SECONDARY Number of Participants With Infection-related Hospitalizations During Initial Care and Follow-up That Resulted in Admission to Intensive Care Unit |
3; 0 | — |
| SECONDARY Number of Participants With All Cause Hospitalizations in the 30 Days Post Discharge From the Hospital or Release From the ED |
7; 12 | — |
| SECONDARY Number of Participants With Infection-related Emergency Department (ED) Visits |
22; 19 | — |
| SECONDARY Number of Participants With Infection-related Outpatient Healthcare Visits |
57; 39 | — |
| SECONDARY Use of a Peripherally-Inserted Central Catheter (PICC) Line or Central Line to Administer Antibiotic Therapy |
93; 141; 0; 0; 1; 1 | — |
| SECONDARY Number of Participants With Infection-related Healthcare Visits Due to PICC Line or Central Line Used to Administer Antibiotic Therapy |
2; 1 | — |
| SECONDARY Number of Participants With Serious Adverse Events (SAEs) |
11; 16 | — |
| SECONDARY Patient Satisfaction With Care: Overall Health |
12; 22; 38; 31; 35; 40 | — |
| SECONDARY Patient Satisfaction With Care: Wait in Emergency Room |
7.8; 8.3 | — |
| SECONDARY Patient Satisfaction With Care: Hospitalization |
63; 27; 56; 97 | — |
| SECONDARY Patient Satisfaction With Care: Satisfaction With Hospital Stay |
8.2; 8.0 | — |
| SECONDARY Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay |
11; 8; 11; 10; 8; 8 | — |
| SECONDARY Patient Satisfaction With Care: Received IV Antibiotic Therapy for Skin Infections |
87; 119; 32; 5 | — |
| SECONDARY Patient Satisfaction With Care: Satisfaction With Receiving IV Antibiotic Therapy |
8.7; 9.0 | — |
| SECONDARY Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV |
37; 50; 48; 81; 38; 52 | — |
| SECONDARY Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV |
2; 1; 3; 4; 1; 1 | — |
| SECONDARY Patient Satisfaction With Care: IV Therapy Hindering Normal Activities of Daily Living |
66; 94; 6; 10; 6; 11 | — |
| SECONDARY Patient Satisfaction With Care: Concerned About Receiving Your IV Therapy |
62; 80; 8; 19; 8; 12 | — |
| SECONDARY Patient Satisfaction With Care: Satisfied With the Number of IV Infusions Received Per Day |
8.4; 9.0 | — |
| SECONDARY Patient Satisfaction With Care: Satisfaction With the Average Time to Administer Each IV |
8.6; 8.8 | — |
| SECONDARY Patient Satisfaction With Care: Time to Travel to Appointments to Receive IV |
7; 19; 5; 17; 2; 4 | — |
| SECONDARY Patient Satisfaction With Care: Average Time to be Seen by a Healthcare Provider |
4; 17; 7; 10; 3; 4 | — |
| SECONDARY Patient Satisfaction With Care: Healthcare Setting Preferred if Treated Again for a Skin Infection With IV |
42; 17; 74; 106 | — |
| SECONDARY Patient Satisfaction With Care: Factors Contributing to Preference for Outpatient Care |
52; 91; 37; 44; 48; 65 | — |
| SECONDARY Patient Satisfaction With Care: Regimen Preferred if Treated Again for a Similar Skin Infection With IV |
65; 107; 14; 6; 38; 8 | — |
| SECONDARY Patient Satisfaction With Care: Time Willing to Spend Receiving Each IV |
73; 87; 28; 32; 13; 3 | — |
| SECONDARY Patient Satisfaction With Care: Find Value in a Physician |
13; 5; 13; 8; 38; 37 | — |
| SECONDARY Patient Work and Productivity Loss as Assessed Through the Work Productivity and Activity Impairment Questionnaire |
17.4; 18.9; 14.5; 10.8; 21.3; 16.4 | — |
| SECONDARY Patient Health-related Quality of Life (HRQoL) Assessed by the Short Form 12 (SF-12) 12-Item Patient Questionnaire |
51.2; 52.6; 46.4; 47.8 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02961764). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.