Back to resultsDalbavancin Outpatient Pilot
Primary Purpose
Gram-Positive Bacterial Infections, Soft Tissue Infections
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Dalbavancin
Sponsored by
About this trial
This is an interventional treatment trial for Gram-Positive Bacterial Infections focused on measuring Dalbavacin
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dalbavancin
Arm Description
Participants with susceptible gram-positive infections requiring prolonged parenteral antibiotic therapy will be treated with dalbavancin.
Outcomes
Primary Outcome Measures
Number of participants with resolution of infection
Number of participants with no recurrent signs or symptom of infection
Secondary Outcome Measures
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.
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.
Number of participants with hospital readmission - week 6
Number of participants readmitted for the primary infection under treatment or related complication.
Number of participants with hospital readmission - Month 6
Number of participants readmitted for the primary infection under treatment or related complication.
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.
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.
Number of adverse events leading to discontinuation of study drug -week 6
Number of adverse events leading to discontinuation of study drug - 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
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
Costs of antibiotic therapy
Costs of antibiotic therapy will be measured by combined estimated total costs per participant of inpatient and outpatient antibiotic therapy.
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.
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.
Number of participants with reported overdose
Number of participants with new enrollment in addiction treatment
Number of participants re-admitted for addiction-related issue
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.
Full Information
NCT ID
NCT03982030
First Posted
June 10, 2019
Last Updated
May 1, 2023
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03982030
Brief Title
Dalbavancin Outpatient Pilot
Official Title
An Open-label, Pilot Clinical Trial of Dalbavancin for the Treatment of Susceptible Gram-positive Infections Requiring Prolonged Intravenous Antibiotic Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of funding
Study Start Date
April 2023 (Anticipated)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
4. Oversight
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
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gram-Positive Bacterial Infections, Soft Tissue Infections
Keywords
Dalbavacin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dalbavancin
Arm Type
Experimental
Arm Description
Participants with susceptible gram-positive infections requiring prolonged parenteral antibiotic therapy will be treated with dalbavancin.
Intervention Type
Drug
Intervention Name(s)
Dalbavancin
Other Intervention Name(s)
Dalvance
Intervention Description
Dalbavancin 1.5g IV at day 0, day 8-10
Primary Outcome Measure Information:
Title
Number of participants with resolution of infection
Description
Number of participants with no recurrent signs or symptom of infection
Time Frame
Week 6
Secondary Outcome Measure Information:
Title
Number of participants with development of breakthrough infection - week 6
Description
Number of participants with worsening signs or symptoms of primary infection or development of new infection.
Time Frame
Week 6
Title
Number of participants with development of breakthrough infection - Month 6
Description
Number of participants with worsening signs or symptoms of primary infection or development of new infection.
Time Frame
Month 6
Title
Number of participants with hospital readmission - week 6
Description
Number of participants readmitted for the primary infection under treatment or related complication.
Time Frame
Week 6
Title
Number of participants with hospital readmission - Month 6
Description
Number of participants readmitted for the primary infection under treatment or related complication.
Time Frame
Month 6
Title
Number of participants with need for further surgical intervention - week 6
Description
Number of participants that need surgical intervention for primary infection prior to end of study participation.
Time Frame
Week 6
Title
Number of participants with need for further surgical intervention - Month 6
Description
Number of participants that need surgical intervention for primary infection prior to end of study participation.
Time Frame
Month 6
Title
Number of adverse events leading to discontinuation of study drug -week 6
Time Frame
Week 6
Title
Number of adverse events leading to discontinuation of study drug - Month 6
Time Frame
Month 6
Title
Number of participants loss to follow-up - week 6
Description
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
Time Frame
Week 6
Title
Number of participants loss to follow-up - Month 6
Description
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
Time Frame
Month 6
Title
Costs of antibiotic therapy
Description
Costs of antibiotic therapy will be measured by combined estimated total costs per participant of inpatient and outpatient antibiotic therapy.
Time Frame
Month 6
Title
Participant Study Questionnaire week 4
Description
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.
Time Frame
week 4
Title
Participant Study Questionnaire week 24
Description
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.
Time Frame
Month 6
Title
Number of participants with reported overdose
Time Frame
Month 6
Title
Number of participants with new enrollment in addiction treatment
Time Frame
Month 6
Title
Number of participants re-admitted for addiction-related issue
Time Frame
Month 6
Title
Time investment per patient required to follow this model
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caryn Morse, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Dalbavancin Outpatient Pilot
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