Gram-Positive Bacterial Infections, Soft Tissue Infections
Conditions
Keywords
Dalbavacin
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.
Interventions
Dalbavancin 1.5g IV at day 0, day 8-10
Sponsors
Study design
Eligibility
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with resolution of infection | Week 6 | Number of participants with no recurrent signs or symptom of infection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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. |
| 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 |