Dalbavancin Outpatient Pilot

NCT ID: NCT03982030

Last Updated: 2023-05-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-30
• Study Completion Date: 2025-07-31

Brief Summary

The purpose of this research is to determine if a new antibiotic called dalbavancin will work to treat and cure certain infections while reducing the need for daily antibiotics by vein.

Detailed Description

A phase 4, single-center, pilot open-label trial assessing the safety and efficacy of dalbavancin in the outpatient therapy of susceptible gram-positive infections requiring prolonged intravenous therapy.

Conditions

Gram-Positive Bacterial Infections; Soft Tissue Infections

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dalbavancin

Participants with susceptible gram-positive infections requiring prolonged parenteral antibiotic therapy will be treated with dalbavancin.

Group Type: EXPERIMENTAL

Dalbavancin

Intervention Type: DRUG

Dalbavancin 1.5g IV at day 0, day 8-10

Interventions

Dalbavancin

Dalbavancin 1.5g IV at day 0, day 8-10

Intervention Type: DRUG

Other Intervention Names

Dalvance

Eligibility Criteria

Inclusion Criteria

• >=18 years of age
• Provide informed consent
• Agreement to attend required follow-up visits with reasonable transportation plan
• Afebrile for at least 24 hours prior to enrollment
• Expected survival ≥3 months
• If female, non-pregnant and non-lactating; all females of child-bearing potential must have a negative pregnancy test prior to study entry and must agree to use a highly effective method of birth control during the study and for one month thereafter.
• Anticipated hospital discharge within 8 days
• Joint and bone infection:
• Sterile site culture positive for susceptible organism
• Participants with bacteremia and right-sided infective endocarditis (IE):

• 2 or more blood cultures positive for S. aureus (MSSA or MRSA or Streptococci)
• Blood cultures negative for 72 hours within 7 days on standard of care antibiotic therapy
• Definite diagnosis of right sided infective endocarditis by Duke Criteria
• Echocardiographic assessment (TTE or TEE)
• For patients with opioid use disorder and history of injection opioid use,

• Injection of opioid substances (IOS) in the last 6 months
• Fulfill criteria for opioid use disorder

Exclusion

• Polymicrobial infection
• Baseline QTc >500 msec
• Creatinine clearance <30 mL per min
• Immunocompromised from neutropenia, AIDS, malignancy, chemotherapy, or receiving immunosuppressant medication including systemic corticosteroids (intranasal or inhaled corticosteroids acceptable)
• Patients with documented allergies to lipoglycopeptides, vancomycin, or teicoplanin
• Concurrent diseases that, in the Investigator's medical judgment, would interfere with the conduct of the study, confound the interpretation of the study results, or endanger the patient's well-being
• For participants with right-sided IE:
• No mitral or aortic valve involvement on echocardiogram
• Large, mobile vegetations (>10mm)
• Perivalvular abscess
• Presence of an intracardiac device (defibrillator or pacer) or prosthetic valve

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Caryn Morse, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Other Identifiers

IRB00054355

Identifier Type: -

Identifier Source: org_study_id