New Critical Pathway for Bacterial Infection

Phase 4

Waitlist Available

Research Sponsored by Allergan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 44 days

Awards & highlights

Pivotal Trial

No Placebo-Only Group

All Individual Drugs Already Approved

Drug Has Already Been Approved

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)

Eligible Conditions

Bacterial Infection
Skin Infections

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 44 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~44 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 44 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Change From Baseline in Response to Treatment at End of Treatment Visit

Healthcare Costs

Patient Health-related Quality of Life (HRQoL) Assessed by the Short Form 12 (SF-12) 12-Item Patient Questionnaire

+16 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Active Control

Group I: New Critical PathwayActive Control1 Intervention

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.

Group II: Usual CareActive Control1 Intervention

Participants who receive Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.

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