A Phase 4 interventional study of Dalbavancin in Gram-Positive Bacterial Infections and Soft Tissue Infections, sponsored by Wake Forest University Health Sciences. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-03.
Sponsored by Wake Forest University Health Sciences · Phase 4, Interventional, and Treatment
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
Browse Infections studies →Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants with bacteremia and right-sided infective endocarditis (IE):
For patients with opioid use disorder and history of injection opioid use,
Exclusion
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
Also known as: Dalvance
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.
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
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Wake Forest University Health Sciences