Dalbavancin Outpatient Pilot

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT03982030
Collaborator
(none)
24
1
27

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-label, Pilot Clinical Trial of Dalbavancin for the Treatment of Susceptible Gram-positive Infections Requiring Prolonged Intravenous Antibiotic Therapy
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2025
Anticipated Study Completion Date :
Jul 1, 2025

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Number of participants with resolution of infection [Week 6]

      Number of participants with no recurrent signs or symptom of infection

    Secondary Outcome Measures

    1. Number of participants with development of breakthrough infection - week 6 [Week 6]

      Number of participants with worsening signs or symptoms of primary infection or development of new infection.

    2. Number of participants with development of breakthrough infection - Month 6 [Month 6]

      Number of participants with worsening signs or symptoms of primary infection or development of new infection.

    3. Number of participants with hospital readmission - week 6 [Week 6]

      Number of participants readmitted for the primary infection under treatment or related complication.

    4. Number of participants with hospital readmission - Month 6 [Month 6]

      Number of participants readmitted for the primary infection under treatment or related complication.

    5. Number of participants with need for further surgical intervention - week 6 [Week 6]

      Number of participants that need surgical intervention for primary infection prior to end of study participation.

    6. Number of participants with need for further surgical intervention - Month 6 [Month 6]

      Number of participants that need surgical intervention for primary infection prior to end of study participation.

    7. Number of adverse events leading to discontinuation of study drug -week 6 [Week 6]

    8. Number of adverse events leading to discontinuation of study drug - Month 6 [Month 6]

    9. Number of participants loss to follow-up - week 6 [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

    10. Number of participants loss to follow-up - Month 6 [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

    11. Costs of antibiotic therapy [Month 6]

      Costs of antibiotic therapy will be measured by combined estimated total costs per participant of inpatient and outpatient antibiotic therapy.

    12. Participant Study Questionnaire week 4 [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.

    13. Participant Study Questionnaire week 24 [Month 6]

      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.

    14. Number of participants with reported overdose [Month 6]

    15. Number of participants with new enrollment in addiction treatment [Month 6]

    16. Number of participants re-admitted for addiction-related issue [Month 6]

    17. Time investment per patient required to follow this model [6 months]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Wake Forest University Health Sciences

    Investigators

    • Principal Investigator: Caryn Morse, MD, Wake Forest University Health Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Wake Forest University Health Sciences
    ClinicalTrials.gov Identifier:
    NCT03982030
    Other Study ID Numbers:
    • IRB00054355
    First Posted:
    Jun 11, 2019
    Last Update Posted:
    Jun 30, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Wake Forest University Health Sciences
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 30, 2022