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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dalbavancin | Drug | Dalbavancin administered as a single IV dose of 1500 mg over 30 minutes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Infection-related Total Admitted Hospital Days | 44 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Total Admitted Hospital Days | 44 Days | |
| Number of Participants With Infection-related Major Surgical Interventions That Required Operating Room Time | 44 Days | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Gillard | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medicine | New York | New York | 10065 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31713130 | Derived | 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. |
| Label | URL |
|---|---|
| Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact IR-CTRegistration@Allergan.com for assistance. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI. |
| FG001 | New Critical Pathway | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI. |
| BG001 | New Critical Pathway |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Infection-related Total Admitted Hospital Days | 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. | Posted | Mean | Standard Deviation | Days | 44 Days |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycaemia | Metabolism and nutrition disorders | MEDRA 20.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MEDRA 20.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area, Head | Allergan | 714-246-4500 | IR-CTRegistration@allergan.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 3, 2017 | Oct 30, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 9, 2018 | Dec 12, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
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| ID | Term |
|---|---|
| C469289 | dalbavancin |
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| Usual Care | Drug | Usual care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI. |
|
| Number of Participants With Infection-related Hospitalizations |
| 44 Days |
| Number of Participants With Infection-related Hospitalizations That Resulted in Admission to Intensive Care Unit | 44 Days |
| Number of Participants With All Cause Hospitalizations in the 30 Days Post Discharge From the Hospital | Follow-up: 30 Days |
| Number of Participants With Infection-related Emergency Department (ED) Visits | 44 Days |
| Number of Participants With Infection-related Outpatient Healthcare Visits | 44 Days |
| Use of a Peripherally-Inserted Central Catheter (PICC) Line or Central Line to Administer Antibiotic Therapy | 44 Days |
| Number of Participants With Infection-related Healthcare Visits Due to PICC Line or Central Line Used to Administer Antibiotic Therapy | 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 | Baseline, Day 14 |
| Number of Participants With Serious Adverse Events (SAEs) | 44 Days |
| Patient Satisfaction With Care: Overall Health | Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported). | 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. | 14 Days |
| Patient Satisfaction With Care: Hospitalization | Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported). | 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. | 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). | 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). | 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. | 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). | 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). | 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). | 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). | 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. | 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. | 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). | 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). | 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). | 14 Days |
| Patient Work and Productivity Loss as Assessed Through the Work Productivity and Activity Impairment Questionnaire | 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. | Day 14 |
| Healthcare Costs | Cost of hospital inpatient stays, ED visits, healthcare visits, procedures, and biological tests | 44 Days |
| No recording of dalbavancin |
|
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.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
|
|
|
| Secondary | Number of Total Admitted Hospital Days | 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. | Posted | Mean | Standard Deviation | Days | 44 Days |
|
|
|
|
| Secondary | Number of Participants With Infection-related Major Surgical Interventions That Required Operating Room Time | 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. | Posted | Count of Participants | Participants | 44 Days |
|
|
|
| Secondary | Number of Participants With Infection-related Hospitalizations | 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. | Posted | Count of Participants | Participants | 44 Days |
|
|
|
| Secondary | Number of Participants With Infection-related Hospitalizations That Resulted in Admission to Intensive Care Unit | 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. | Posted | Count of Participants | Participants | 44 Days |
|
|
|
| Secondary | Number of Participants With All Cause Hospitalizations in the 30 Days Post Discharge From the Hospital | 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. | Posted | Count of Participants | Participants | Follow-up: 30 Days |
|
|
|
| Secondary | Number of Participants With Infection-related Emergency Department (ED) Visits | 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. | Posted | Count of Participants | Participants | 44 Days |
|
|
|
| Secondary | Number of Participants With Infection-related Outpatient Healthcare Visits | 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. | Posted | Count of Participants | Participants | 44 Days |
|
|
|
| Secondary | Use of a Peripherally-Inserted Central Catheter (PICC) Line or Central Line to Administer Antibiotic Therapy | 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. | Posted | Count of Participants | Participants | 44 Days |
|
|
|
| Secondary | Number of Participants With Infection-related Healthcare Visits Due to PICC Line or Central Line Used to Administer Antibiotic Therapy | 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. | Posted | Count of Participants | Participants | 44 Days |
|
|
|
| Secondary | 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 | 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. | Posted | Count of Participants | Participants | Baseline, Day 14 |
|
|
|
| Secondary | Number of Participants With Serious Adverse Events (SAEs) | 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. | Posted | Count of Participants | Participants | 44 Days |
|
|
|
| Secondary | Patient Satisfaction With Care: Overall Health | Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported). | FAS population. 43 and 34 patients provided any survey data in the usual care group and the new critical pathway group, respectively. 40 and 32 patients completed all survey questions in the usual care group and new critical pathway group, respectively. | Posted | Count of Participants | Participants | 14 Days |
|
|
|
| Secondary | 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. | FAS population. 43 and 34 patients provided any survey data in the usual care group and the new critical pathway group, respectively. 40 and 32 patients completed all survey questions in the usual care group and new critical pathway group, respectively. | Posted | Mean | Standard Deviation | scores on a scale | 14 Days |
|
|
|
| Secondary | Patient Satisfaction With Care: Hospitalization | Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported). | FAS population. 43 and 34 patients provided any survey data in the usual care group and the new critical pathway group, respectively. 40 and 32 patients completed all survey questions in the usual care group and new critical pathway group, respectively. | Posted | Count of Participants | Participants | 14 Days |
|
|
|
| Secondary | 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. | FAS population. 43 and 34 patients provided any survey data in the usual care group and the new critical pathway group, respectively. 40 and 32 patients completed all survey questions in the usual care group and new critical pathway group, respectively. | Posted | Mean | Standard Deviation | scores on a scale | 14 Days |
|
|
|
| Secondary | 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). | 43 & 34 patients provided any survey data in the usual care group & new critical pathway group; 40 & 32 patients completed all questions in the usual care group & new critical pathway group; 42 & 34 patients answered this question in the usual care group & new critical pathway group, respectively. Patients may have checked multiple responses. | Posted | Number | Participants | 14 Days |
|
|
|
| Secondary | 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). | FAS Population. 43 & 34 patients provided any survey data in the usual care group & new critical pathway group; 40 & 32 patients completed all survey questions in the usual care group & new critical pathway group; 43 & 33 patients answered this survey question in the usual care group & new critical pathway group, respectively. | Posted | Count of Participants | Participants | 14 Days |
|
|
|
| Secondary | 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. | FAS Population. 43 & 34 patients provided any survey data in the usual care group & new critical pathway group; 40 & 32 patients completed all survey questions in the usual care group & new critical pathway group; 43 & 33 patients answered this survey question in the usual care group & new critical pathway group, respectively. | Posted | Mean | Standard Deviation | scores on a scale | 14 Days |
|
|
|
| Secondary | 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). | 43 & 34 patients provided any survey data in the usual care group & new critical pathway group; 40 & 32 patients completed all questions in the usual care group & new critical pathway group; 43 & 33 patients answered this question in the usual care group & new critical pathway group, respectively. Patients may have checked multiple responses. | Posted | Number | Participants | 14 Days |
|
|
|
| Secondary | 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). | 43 & 34 patients provided any survey data in the usual care group & new critical pathway group; 40 & 32 patients completed all questions in the usual care group & new critical pathway group; 43 & 33 patients answered this question in the usual care group & new critical pathway group, respectively. Patients may have checked multiple responses. | Posted | Number | Participants | 14 Days |
|
|
|
| Secondary | 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). | FAS Population. 43 & 34 patients provided any survey data in the usual care group & new critical pathway group; 40 & 32 patients completed all survey questions in the usual care group & new critical pathway group; 42 & 33 patients answered this survey question in the usual care group & new critical pathway group, respectively. | Posted | Count of Participants | Participants | 14 Days |
|
|
|
| Secondary | Patient Satisfaction With Care: Concerned About Receiving Your IV Therapy | Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported). | FAS Population. 43 & 34 patients provided any survey data in the usual care group & new critical pathway group; 40 & 32 patients completed all survey questions in the usual care group & new critical pathway group; 42 & 33 patients answered this survey question in the usual care group & new critical pathway group, respectively. | Posted | Count of Participants | Participants | 14 Days |
|
|
|
| Secondary | 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. | FAS Population. 43 & 34 patients provided any survey data in the usual care group & new critical pathway group; 40 & 32 patients completed all survey questions in the usual care group & new critical pathway group; 43 & 33 patients answered this survey question in the usual care group & new critical pathway group, respectively. | Posted | Mean | Standard Deviation | scores on a scale | 14 Days |
|
|
|
| Secondary | 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. | FAS Population. 43 & 34 patients provided any survey data in the usual care group & new critical pathway group; 40 & 32 patients completed all survey questions in the usual care group & new critical pathway group; 43 & 33 patients answered this survey question in the usual care group & new critical pathway group, respectively. | Posted | Mean | Standard Deviation | scores on a scale | 14 Days |
|
|
|
| Secondary | 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). | FAS Population. 43 & 34 patients provided any survey data in the usual care group & new critical pathway group; 40 & 32 patients completed all survey questions in the usual care group & new critical pathway group; 43 & 34 patients answered this survey question in the usual care group & new critical pathway group, respectively. | Posted | Count of Participants | Participants | 14 Days |
|
|
|
| Secondary | 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). | FAS Population. 43 & 34 patients provided any survey data in the usual care group & new critical pathway group; 40 & 32 patients completed all survey questions in the usual care group & new critical pathway group; 41 & 34 patients answered this survey question in the usual care group & new critical pathway group, respectively. | Posted | Count of Participants | Participants | 14 Days |
|
|
|
| Secondary | Patient Satisfaction With Care: Find Value in a Physician | Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported). | FAS Population. 43 & 34 patients provided any survey data in the usual care group & new critical pathway group; 40 & 32 patients completed all survey questions in the usual care group & new critical pathway group; 43 & 34 patients answered this survey question in the usual care group & new critical pathway group, respectively. | Posted | Count of Participants | Participants | 14 Days |
|
|
|
| Secondary | Patient Work and Productivity Loss as Assessed Through the Work Productivity and Activity Impairment Questionnaire | FAS population. 43 and 34 patients provided any survey data in the usual care group and the new critical pathway group, respectively.14 and 9 patients completed all survey questions in the usual care group and new critical pathway group, respectively. 17 and 20 patients were employed. | Posted | Mean | Standard Deviation | Percentage | Day 10-14 |
|
|
|
| Secondary | 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. | FAS population. 43 and 34 patients provided any survey data in the usual care group and the new critical pathway group, respectively. 42 and 34 patients completed all survey questions in the usual care group and new critical pathway group, respectively. | Posted | Mean | Standard Deviation | score on a scale | Day 14 |
|
|
|
| Secondary | Healthcare Costs | Cost of hospital inpatient stays, ED visits, healthcare visits, procedures, and biological tests | 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. | Posted | Mean | Standard Deviation | USD | 44 Days |
|
|
|
| 0 |
| 48 |
| 1 |
| 48 |
| 0 |
| 48 |
| EG001 | New Critical Pathway | 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. | 0 | 42 | 3 | 42 | 3 | 42 |
| Cellulitis | Infections and infestations | MEDRA 20.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MEDRA 20.0 | Systematic Assessment |
|
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| D001519 | Behavior |
| Peripheral IV |
|
| No Line |
|
| Failure |
|
| Unknown |
|
| Good |
|
| Fair |
|
| Poor |
|
| Stay got in the way of providing care to others |
|
| Hospital stay was expensive |
|
| Did not provide adequate monitoring by providers |
|
| Did not provide well trained healthcare providers |
|
| Hospital stay made me feel worse |
|
| Hospital stay made me feel concerned |
|
| Hospital stay was uncomfortable |
|
| Hospital stay disrupted my sleep |
|
| Other |
|
| I was not dissatisfied with my hospital stay |
|
| Allowed me to return to providing care to others |
|
| IV antibiotic therapy was affordable |
|
| Administered at appointments that I could schedule |
|
| Administered quickly once arrived at appt |
|
| Administered at setting that had convenient hours |
|
| Ensured regular monitoring by healthcare providers |
|
| Administered by skilled healthcare providers |
|
| IV antibiotic therapy made me feel better |
|
| Allowed to receive care for skin infection at home |
|
| Convenient to administer by self/caregiver at home |
|
| Other |
|
| Not satisfied with receiving IV antibiotic therapy |
|
| Got in the way of providing care to others |
|
| IV antibiotic therapy was expensive |
|
| Required me to make appointments |
|
| Administered at healthcare setting w/limited hours |
|
| Required traveling to and from appointments |
|
| Required to wait to be seen by provider |
|
| IV antibiotic therapy took too long to administer |
|
| Administered too frequently |
|
| Required having a PICC or central line inserted |
|
| Caused an IV site infection |
|
| IV antibiotic therapy made me feel worse |
|
| Not adequately monitored by healthcare providers |
|
| Not administered by skilled healthcare providers |
|
| IV antibiotic therapy made me feel concerned |
|
| Required a nurse/healthcare worker coming to home |
|
| Required administration to self/caregiver at home |
|
| Other |
|
| Not dissatisfied w/receiving IV antibiotic therapy |
|
| Some of the time |
|
| Most of the time |
|
| All of the time |
|
| Some of the time |
|
| Most of the time |
|
| All of the time |
|
| Regimen 3 |
|
| About 1.5 to 2 hours |
|
| About 3 hours or longer |
|
| Probably so |
|
| Definitely so |
|
| Impairment while working |
|
|
| Overall work impairment |
|
|
| Activity impairment |
|
|