Development of a New Critical Pathway for Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
NCT03233438 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 91
Last updated 2020-01-18
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)
Conditions
- Bacterial Infections
- Acute Bacterial Skin and Skin Structure Infection
Interventions
- DRUG
-
Dalbavancin
Dalbavancin administered as a single IV dose of 1500 mg over 30 minutes.
- DRUG
-
Usual Care
Usual care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
Sponsors & Collaborators
-
Allergan
lead INDUSTRY
Principal Investigators
-
Patrick Gillard · Allergan
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-07-24
- Primary Completion
- 2018-10-30
- Completion
- 2018-10-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Efficacy and Safety Study of Brilacidin to Treat Serious Skin Infections
NCT02052388 ·Status: COMPLETED ·Phase: PHASE2
-
Delafloxacin vs Vancomycin and Aztreonam for the Treatment of Acute Bacterial Skin and Skin Structure Infections
NCT01984684 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections
NCT01431339 ·Status: COMPLETED ·Phase: PHASE3
-
Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections in Children, Known or Suspected to be Caused by Susceptible Gram-positive Organisms, Including MRSA
NCT02814916 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections
NCT01339091 ·Status: COMPLETED ·Phase: PHASE3
-
Dalbavancin Outpatient Pilot
NCT03982030 ·Status: WITHDRAWN ·Phase: PHASE4
-
Safety and Efficacy of Dalbavancin Versus Active Comparator in Adult Patients With Osteomyelitis
NCT03091439 ·Status: TERMINATED ·Phase: PHASE2
-
Study of Debio 1450 for Bacterial Skin Infections
NCT02426918 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety of Dalbavancin Compared to Standard of Care Antibiotic Therapy for the Completion of Treatment of Patients With Complicated Bacteremia or Infective Endocarditis
NCT03148756 ·Status: TERMINATED ·Phase: PHASE2
-
Dalbavancin Versus Standard Antibiotic Therapy for Catheter-related Bloodstream Infections Due to Staphylococcus Aureus
NCT05117398 ·Status: RECRUITING ·Phase: PHASE3
-
Study Of Dalbavancin Drug Levels Achieved In Hospitalized Adolescents Who Are Receiving Antibiotic Therapy For Bacterial Infections
NCT00678106 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Safety of a Single Intravenous (IV) Dose of Orbactiv (Oritavancin) in Participants on Chronic Warfarin Therapy Being Treated For Acute Bacterial Skin and Skin Structure Infection (ABSSSI)
NCT02452918 ·Status: COMPLETED ·Phase: PHASE4
-
Phase 2 Safety and Efficacy Study of Daptomycin in Complicated Skin and Skin Structure Infections
NCT00426933 ·Status: COMPLETED ·Phase: PHASE2
-
Relative Exposure and Safety Study of Kimyrsa in ABSSSI Patients
NCT03873987 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Efficacy Study of CUBICIN (Daptomycin) Under Conditions of Actual Use
NCT01219114 ·Status: WITHDRAWN
-
Daptomycin in the Treatment of Patients With Renal Insufficiency and Complicated Skin and Skin Structure Infections
NCT00102947 ·Status: TERMINATED ·Phase: PHASE4
-
Study to Compare Efficacy and Safety of Daptomycin in Elderly Patients With Complicated Skin and Soft Tissue Infections
NCT01184872 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy of Dalbavancin Versus Vancomycin in the Treatment of Catheter-Related Bloodstream Infections
NCT00057369 ·Status: UNKNOWN ·Phase: PHASE2
-
Study Evaluate the PK Profile of Dalbavancin in Infants and Neonates Patients With Known or Suspected Bacterial Infection
NCT02688790 ·Status: TERMINATED ·Phase: PHASE1
-
Daptomycin for the Treatment of Infections Due to Gram-Positive Bacteria
NCT00055198 ·Status: TERMINATED ·Phase: PHASE3
-
Study on the Safety and Efficacy of Dalbavancin Versus Active Comparator in Adult Participants With Osteomyelitis
NCT02685033 ·Status: COMPLETED ·Phase: PHASE2
-
Sivextro in Acute Bacterial Skin and Skin Structure Infection (ABSSSI) in Hospitalized Patients. A Global Observational Study
NCT02991131 ·Status: TERMINATED
-
Study of Daptomycin Safety and Efficacy for Complicated Skin and Skin Structure Infections (cSSSI) and Bacteremia in Renal Impairment
NCT01104662 ·Status: TERMINATED ·Phase: PHASE4
-
Safety of Either a Single or Two Intravenous Doses of Orbactiv in Participants With Acute Bacterial Skin and Skin Structure Infection
NCT02925416 ·Status: COMPLETED ·Phase: PHASE4
-
Safety and Efficacy Study of Daptomycin in Pediatric Participants (1 to 17 Years-old) With Skin and Skin Structure Infections
NCT00711802 ·Status: COMPLETED ·Phase: PHASE4