Dalbavancin Outpatient Pilot

NCT03982030 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: IRB00054355
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gram-Positive Bacterial Infections; Soft Tissue Infections

Keywords

Dalbavacin

Outcome Measures

Primary Outcomes (1)

• Number of participants with resolution of infection

  Number of participants with no recurrent signs or symptom of infection

  Week 6

Secondary Outcomes (17)

• Number of participants with development of breakthrough infection - week 6

  Week 6

• Number of participants with development of breakthrough infection - Month 6

  Month 6

• Number of participants with hospital readmission - week 6

  Week 6

• Number of participants with hospital readmission - Month 6

  Month 6

• Number of participants with need for further surgical intervention - week 6

  Week 6

Study Arms (1)

Dalbavancin

EXPERIMENTAL

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

Drug: Dalbavancin

Interventions

Dalbavancin DRUG

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

Also known as: Dalvance

Dalbavancin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>=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):
• 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,

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

MeSH Terms

Conditions

Gram-Positive Bacterial Infections; Soft Tissue Infections

Interventions

dalbavancin

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Caryn Morse, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2019
• First Posted: June 11, 2019
• Study Start: April 1, 2023
• Primary Completion: April 1, 2025
• Study Completion: July 1, 2025
• Last Updated: May 3, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share