Phase 4
N=91
Development of a New Critical Pathway for Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
Bacterial Infections · Acute Bacterial Skin and Skin Structure Infection
Bottom Line
View on ClinicalTrials.gov: NCT03233438 ↗Enrolled (actual)
91
Serious AEs
4.4%
Results posted
Jan 2020
Primary outcome: Primary: Number of Infection-related Total Admitted Hospital Days — 4.8; 3.2 Days — p=0.003
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Dalbavancin (Drug); Usual Care (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Infection-related Total Admitted Hospital Days |
4.8; 3.2 | 0.003 sig |
| SECONDARY Number of Total Admitted Hospital Days |
4.9; 3.2 | 0.003 sig |
| SECONDARY Number of Participants With Infection-related Major Surgical Interventions That Required Operating Room Time |
48; 41; 0; 1 | — |
| SECONDARY Number of Participants With Infection-related Hospitalizations |
48; 39; 0; 3 | — |
| SECONDARY Number of Participants With Infection-related Hospitalizations That Resulted in Admission to Intensive Care Unit |
0; 0 | — |
| SECONDARY Number of Participants With All Cause Hospitalizations in the 30 Days Post Discharge From the Hospital |
47; 39; 1; 3 | — |
| SECONDARY Number of Participants With Infection-related Emergency Department (ED) Visits |
46; 40; 2; 2 | — |
| SECONDARY Number of Participants With Infection-related Outpatient Healthcare Visits |
26; 20; 22; 22 | — |
| SECONDARY Use of a Peripherally-Inserted Central Catheter (PICC) Line or Central Line to Administer Antibiotic Therapy |
0; 0; 1; 0; 27; 42 | — |
| SECONDARY Number of Participants With Infection-related Healthcare Visits Due to PICC Line or Central Line Used to Administer Antibiotic Therapy |
45; 41; 3; 1 | — |
| SECONDARY Change From Baseline in Response to Treatment at End of Treatment Visit |
24; 24; 0; 0; 12; 9 | — |
| SECONDARY Number of Participants With Serious Adverse Events (SAEs) |
1; 3 | — |
| SECONDARY Patient Satisfaction With Care: Overall Health |
2; 8; 16; 10; 9; 7 | — |
| SECONDARY Patient Satisfaction With Care: Wait in Emergency Room |
5.1; 6.9 | — |
| SECONDARY Patient Satisfaction With Care: Hospitalization |
43; 34; 0; 0 | — |
| SECONDARY Patient Satisfaction With Care: Satisfaction With Hospital Stay |
7.4; 7.4 | — |
| SECONDARY Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay |
13; 6; 17; 8; 10; 5 | — |
| SECONDARY Patient Satisfaction With Care: Received IV Antibiotic Therapy for Skin Infections |
43; 33; 0; 1 | — |
| SECONDARY Patient Satisfaction With Care: Satisfaction With Receiving IV Antibiotic Therapy |
7.1; 8.1 | — |
| SECONDARY Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV |
14; 15; 15; 20; 8; 11 | — |
| SECONDARY Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV |
11; 3; 11; 3; 5; 1 | — |
| SECONDARY Patient Satisfaction With Care: IV Therapy Hindering Normal Activities of Daily Living |
17; 26; 4; 5; 3; 0 | — |
| SECONDARY Patient Satisfaction With Care: Concerned About Receiving Your IV Therapy |
23; 26; 13; 4; 3; 1 | — |
| SECONDARY Patient Satisfaction With Care: Satisfied With the Number of IV Infusions Received Per Day |
7.3; 8.7 | — |
| SECONDARY Patient Satisfaction With Care: Satisfaction With the Average Time to Administer Each IV |
7.5; 8.9 | — |
| SECONDARY Patient Satisfaction With Care: Regimen Preferred if Treated Again for a Similar Skin Infection With IV |
28; 33; 6; 0; 9; 1 | — |
| SECONDARY Patient Satisfaction With Care: Time Willing to Spend Receiving Each IV |
23; 22; 10; 10; 5; 1 | — |
| SECONDARY Patient Satisfaction With Care: Find Value in a Physician |
1; 1; 1; 1; 7; 2 | — |
| SECONDARY Patient Work and Productivity Loss as Assessed Through the Work Productivity and Activity Impairment Questionnaire |
49.9; 36.7; 47.9; 8.9; 59.3; 18.0 | — |
| SECONDARY Patient Health-related Quality of Life (HRQoL) Assessed by the Short Form 12 (SF-12) 12-Item Patient Questionnaire |
43.9; 50.8; 40.5; 46.3 | — |
| SECONDARY Healthcare Costs |
13772.9; 9421.6 | — |
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)
Eligibility Criteria
Inclusion Criteria
- Admitted patients who 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 (NCT03233438). 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.