Dalbavancin Outpatient Pilot

Wake Forest University (WFU)

Status and phase: Withdrawn; Phase 4

Conditions: Gram-Positive Bacterial Infections; Soft Tissue Infections

Treatments: Drug: Dalbavancin

Study type: Interventional

Funder types: Other

Identifiers

NCT03982030

IRB00054355

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

0 participants in 1 patient group

Dalbavancin

Experimental group

Description:

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

Treatment:

Drug: Dalbavancin