Dalbavancin Outpatient Pilot

• Status: Not yet recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest University Health Sciences
• Treatments: Anti-Infective Agents; Dalbavancin; Teicoplanin

Criteria

Inclusion

• >=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