Clinical trial NCT03982030: Dalbavancin Outpatient Pilot
Official title: An Open-label, Pilot Clinical Trial of Dalbavancin for the Treatment of Susceptible Gram-positive Infections Requiring Prolonged Intravenous Antibiotic Therapy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Gram-Positive Bacterial Infections
Soft Tissue Infections
Keywords: Dalbavacin
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2019-06-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Number of participants with resolution of infection
timeFrame: Week 6
Secondary outcomes:
measure: Number of participants with development of breakthrough infection - week 6
timeFrame: Week 6
measure: Number of participants with development of breakthrough infection - Month 6
timeFrame: Month 6
measure: Number of participants with hospital readmission - week 6
timeFrame: Week 6
measure: Number of participants with hospital readmission - Month 6
timeFrame: Month 6
measure: Number of participants with need for further surgical intervention - week 6
timeFrame: Week 6
measure: Number of participants with need for further surgical intervention - Month 6
timeFrame: Month 6
measure: Number of adverse events leading to discontinuation of study drug -week 6
timeFrame: Week 6
measure: Number of adverse events leading to discontinuation of study drug - Month 6
timeFrame: Month 6
measure: Number of participants loss to follow-up - week 6
timeFrame: Week 6
measure: Number of participants loss to follow-up - Month 6
timeFrame: Month 6
measure: Costs of antibiotic therapy
timeFrame: Month 6
measure: Participant Study Questionnaire week 4
timeFrame: week 4
measure: Participant Study Questionnaire week 24
timeFrame: Month 6
measure: Number of participants with reported overdose
timeFrame: Month 6
measure: Number of participants with new enrollment in addiction treatment
timeFrame: Month 6
measure: Number of participants re-admitted for addiction-related issue
timeFrame: Month 6
measure: Time investment per patient required to follow this model
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Wake Forest University Health Sciences
name: Caryn Morse, MD
role: PRINCIPAL_INVESTIGATOR
References: