Development of a New Critical Pathway for Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

January 7, 2020 updated by: Allergan

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)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
91

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Weill Cornell Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Usual Care
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
Usual care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
Active Comparator: 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.
Drug: Dalbavancin
Dalbavancin administered as a single IV dose of 1500 mg over 30 minutes.
Other Names:
  • Dalvance®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of Infection-related Total Admitted Hospital Days
Time Frame: 44 Days
44 Days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Infection-related Emergency Department (ED) Visits
Time Frame: 44 Days
44 Days
Number of Participants With Infection-related Outpatient Healthcare Visits
Time Frame: 44 Days
44 Days
Use of a Peripherally-Inserted Central Catheter (PICC) Line or Central Line to Administer Antibiotic Therapy
Time Frame: 44 Days
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
44 Days
Number of Participants With Serious Adverse Events (SAEs)
Time Frame: 44 Days
44 Days
Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV
Time Frame: 14 Days
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
14 Days
Patient Health-related Quality of Life (HRQoL) Assessed by the Short Form 12 (SF-12) 12-Item Patient Questionnaire
Time Frame: Day 14
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
Number of Total Admitted Hospital Days
Time Frame: 44 Days
44 Days
Number of Participants With Infection-related Major Surgical Interventions That Required Operating Room Time
Time Frame: 44 Days
44 Days
Number of Participants With Infection-related Hospitalizations
Time Frame: 44 Days
44 Days
Number of Participants With Infection-related Hospitalizations That Resulted in Admission to Intensive Care Unit
Time Frame: 44 Days
44 Days
Number of Participants With All Cause Hospitalizations in the 30 Days Post Discharge From the Hospital
Time Frame: Follow-up: 30 Days
Follow-up: 30 Days
Change From Baseline in Response to Treatment at End of Treatment Visit
Time Frame: Baseline, Day 14
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
Patient Satisfaction With Care: Overall Health
Time Frame: 14 Days
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
14 Days
Patient Satisfaction With Care: Wait in Emergency Room
Time Frame: 14 Days
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
Time Frame: 14 Days
Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).
14 Days
Patient Satisfaction With Care: Satisfaction With Hospital Stay
Time Frame: 14 Days
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
Time Frame: 14 Days
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
Time Frame: 14 Days
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
Time Frame: 14 Days
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
Time Frame: 14 Days
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
Time Frame: 14 Days
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
Time Frame: 14 Days
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
Time Frame: 14 Days
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
Time Frame: 14 Days
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
Time Frame: 14 Days
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
Time Frame: 14 Days
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
Time Frame: 14 Days
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
Time Frame: Day 10-14
Day 10-14
Healthcare Costs
Time Frame: 44 Days
Cost of hospital inpatient stays, ED visits, healthcare visits, procedures, and biological tests
44 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Allergan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Patrick Gillard, Allergan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 24, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 26, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 28, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 18, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CMO-US-ID-0528

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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