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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dalbavancin | Experimental | Participants with susceptible gram-positive infections requiring prolonged parenteral antibiotic therapy will be treated with dalbavancin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dalbavancin | Drug | Dalbavancin 1.5g IV at day 0, day 8-10 |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with resolution of infection | Number of participants with no recurrent signs or symptom of infection | Week 6 |
| 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 |
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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):
For patients with opioid use disorder and history of injection opioid use,
Exclusion
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| Name | Affiliation | Role |
|---|---|---|
| Caryn Morse, MD | Wake Forest University Health Sciences | Principal Investigator |
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| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D018461 | Soft Tissue Infections |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C469289 | dalbavancin |
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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 |