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Dalbavancin Outpatient Pilot

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ClinicalTrials.gov Identifier: NCT03982030
Recruitment Status : Not yet recruiting
First Posted : June 11, 2019
Last Update Posted : July 2, 2019
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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
Gram-Positive Bacterial Infections Soft Tissue Infections Drug: Dalbavancin 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
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
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics
Drug Information available for: Dalbavancin

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 Name: Dalvance




Primary Outcome Measures :
  1. Number of participants with resolution of infection [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Week 6 ]
    Number of participants readmitted for the primary infection under treatment or related complication.

  4. Number of participants with hospital readmission - Month 6 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Week 6 ]
  8. Number of adverse events leading to discontinuation of study drug - Month 6 [ Time Frame: Month 6 ]
  9. Number of participants loss to follow-up - week 6 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Month 6 ]
  15. Number of participants with new enrollment in addiction treatment [ Time Frame: Month 6 ]
  16. Number of participants re-admitted for addiction-related issue [ Time Frame: Month 6 ]
  17. Time investment per patient required to follow this model [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03982030


Contacts
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Contact: Caryn G Morse, MD (336) 716-2700 cmorse@wakehealth.edu
Contact: Erin Barnes, MD (336) 716-2700 ebarnes@wakehealth.edu

Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Caryn Morse, MD Wake Forest University Health Sciences

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03982030     History of Changes
Other Study ID Numbers: IRB00054355
First Posted: June 11, 2019    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
Dalbavacin

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Bacterial Infections
Soft Tissue Infections
Gram-Positive Bacterial Infections
Dalbavancin
Teicoplanin
Anti-Infective Agents
Anti-Bacterial Agents