Dalbavancin Outpatient Pilot

An Open-label, Pilot Clinical Trial of Dalbavancin for the Treatment of Susceptible Gram-positive Infections Requiring Prolonged Intravenous Antibiotic Therapy

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.

Study Overview

• Status: Withdrawn
• Conditions: Gram-Positive Bacterial Infections; Soft Tissue Infections
• Intervention / Treatment: Drug: Dalbavancin

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.

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dalbavancin; Participants with susceptible gram-positive infections requiring prolonged parenteral antibiotic therapy will be treated with dalbavancin.	Drug: Dalbavancin; Dalbavancin 1.5g IV at day 0, day 8-10; Other Names: Dalvance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with resolution of infection	Number of participants with no recurrent signs or symptom of infection	Week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with development of breakthrough infection - week 6	Number of participants with worsening signs or symptoms of primary infection or development of new infection.	Week 6
Number of participants with development of breakthrough infection - Month 6	Number of participants with worsening signs or symptoms of primary infection or development of new infection.	Month 6
Number of participants with hospital readmission - week 6	Number of participants readmitted for the primary infection under treatment or related complication.	Week 6
Number of participants with hospital readmission - Month 6	Number of participants readmitted for the primary infection under treatment or related complication.	Month 6
Number of participants with need for further surgical intervention - week 6	Number of participants that need surgical intervention for primary infection prior to end of study participation.	Week 6
Number of participants with need for further surgical intervention - Month 6	Number of participants that need surgical intervention for primary infection prior to end of study participation.	Month 6
Number of adverse events leading to discontinuation of study drug -week 6		Week 6
Number of adverse events leading to discontinuation of study drug - Month 6		Month 6
Number of participants loss to follow-up - week 6	Number of participants that fail to receive second planned dalbavacin dose and attend study visits. failure to attend scheduled visits after receiving second dalbavancin dose	Week 6
Number of participants loss to follow-up - Month 6	Number of participants that fail to receive second planned dalbavacin dose and attend study visits. failure to attend scheduled visits after receiving second dalbavancin dose	Month 6
Costs of antibiotic therapy	Costs of antibiotic therapy will be measured by combined estimated total costs per participant of inpatient and outpatient antibiotic therapy.	Month 6
Participant Study Questionnaire week 4	Participant satisfaction will be measured using the 5 point scale (4-strongly agree, 3-agree, 2 neutral, 1-disagree, and 0-strongly disagree). Higher scores denote better outcome.	week 4
Participant Study Questionnaire week 24	Participant satisfaction will be measured using the 5 point scale (4-strongly agree, 3-agree, 2 neutral, 1-disagree, and 0-strongly disagree). Higher scores denote better outcome.	Month 6
Number of participants with reported overdose		Month 6
Number of participants with new enrollment in addiction treatment		Month 6
Number of participants re-admitted for addiction-related issue		Month 6
Time investment per patient required to follow this model	Time investment per patient will be measured by combined time in minutes spent by study and clinical staff on addiction-related phone calls, paperwork and in-person appointments.	6 months

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2023
• Primary Completion (Anticipated): April 1, 2025
• Study Completion (Anticipated): July 1, 2025

Study Registration Dates

• First Submitted: June 10, 2019
• First Submitted That Met QC Criteria: June 10, 2019
• First Posted (Actual): June 11, 2019

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: May 1, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Dalbavacin
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Soft Tissue Infections; Bacterial Infections; Gram-Positive Bacterial Infections; Anti-Infective Agents; Anti-Bacterial Agents; Dalbavancin
• Other Study ID Numbers: IRB00054355

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No