Dalbavancin Outpatient Pilot
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
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:
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Outcome Measures
Primary Outcome Measures
- Number of participants with resolution of infection [Week 6]
Number of participants with no recurrent signs or symptom of infection
Secondary Outcome Measures
- 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.
- 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.
- Number of participants with hospital readmission - week 6 [Week 6]
Number of participants readmitted for the primary infection under treatment or related complication.
- Number of participants with hospital readmission - Month 6 [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 [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 [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 [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 [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 [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 [Month 6]
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 [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 [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.
- 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 [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
Inclusion
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=18 years of age
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Provide informed consent
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Agreement to attend required follow-up visits with reasonable transportation plan
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Afebrile for at least 24 hours prior to enrollment
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Expected survival ≥3 months
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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.
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Anticipated hospital discharge within 8 days
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Joint and bone infection:
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Sterile site culture positive for susceptible organism
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Participants with bacteremia and right-sided infective endocarditis (IE):
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2 or more blood cultures positive for S. aureus (MSSA or MRSA or Streptococci)
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Blood cultures negative for 72 hours within 7 days on standard of care antibiotic therapy
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Definite diagnosis of right sided infective endocarditis by Duke Criteria
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Echocardiographic assessment (TTE or TEE)
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For patients with opioid use disorder and history of injection opioid use,
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Injection of opioid substances (IOS) in the last 6 months
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Fulfill criteria for opioid use disorder
Exclusion
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Polymicrobial infection
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Baseline QTc >500 msec
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Creatinine clearance <30 mL per min
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Immunocompromised from neutropenia, AIDS, malignancy, chemotherapy, or receiving immunosuppressant medication including systemic corticosteroids (intranasal or inhaled corticosteroids acceptable)
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Patients with documented allergies to lipoglycopeptides, vancomycin, or teicoplanin
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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
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For participants with right-sided IE:
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No mitral or aortic valve involvement on echocardiogram
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Large, mobile vegetations (>10mm)
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Perivalvular abscess
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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.- IRB00054355