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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Dalbavancin 1.5g IV at day 0, day 8-10
Number of participants with resolution of infection
Number of participants with no recurrent signs or symptom of infection
Time frame: Week 6
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.
Time frame: Week 6
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.
Time frame: Month 6
Number of participants with hospital readmission - week 6
Number of participants readmitted for the primary infection under treatment or related complication.
Time frame: Week 6
Number of participants with hospital readmission - Month 6
Number of participants readmitted for the primary infection under treatment or related complication.
Time frame: 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.
Time frame: 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.
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Time frame: Month 6
Number of adverse events leading to discontinuation of study drug -week 6
Time frame: Week 6
Number of adverse events leading to discontinuation of study drug - Month 6
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Month 6
Number of participants with reported overdose
Time frame: Month 6
Number of participants with new enrollment in addiction treatment
Time frame: Month 6
Number of participants re-admitted for addiction-related issue
Time frame: 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.
Time frame: 6 months