Preliminary Evaluation of Dalbavancin's Efficacy in People Who Use Drugs With Severe Gram-positive Infections

19-0650

The Investigators aim to study the outcomes of serious infections due to vancomycin susceptible infections in gram-positive organisms susceptible to vancomycin in people who use drugs (PWUD). The Investigators hypothesize, that a simplified 2-dose dalbavancin regimen, will improve compliance with antimicrobial therapy and that it may facilitate engagement in the treatment of the underlying substance use disorder, and particularly injection drug use - often the true etiology behind these severe infections.

2021-04-30

2023-10-05

2023-10-05

Terminated

Early phase I

11

Inclusion Criteria: 1. Subjects 18+ years of age with bacteremia or deep seated infections (i.e. intra-abdominal, retroperitoneal and/or para-spinal abscesses, intra-thoracic abscess/empyema) 2. Subjects will have injection drug use (IDU) (or SUD) listed as the barrier to OPAT, and 3. Their principal admission diagnosis will require 2 or more weeks of antibiotic treatment for indications, including bacteremia, endocarditis, osteomyelitis and other deep-seated infections with Sa/gpp sensitive to vancomycin 4. No more than 7 days have past since the first positive qualifying culture 5. The subjects will be considered to have an active SUD or IDU: 1. if their infection is directly linked with IDU 2. if they report active psychoactive substance without evidence of remission prior to hospitalization (including prescription medications they have not been authorized to use by any prescribing physician but excluding alcohol and/or tobacco products alone) 3. if their toxicology screen shows illicit substances (including prescription medications they have not been authorized to use by any prescribing physician) Exclusion Criteria: 1. Have an allergy to dalbavancin (or other glycopeptide antibiotics, i.e. vancomycin) 2. Cannot have a peripheral access (i.e. need surgical central access due to poor vasculature), or if they need constant IV access for other IV medications which need to be administered frequently 3. Have central nervous system (CNS) infections or spinal epidural abscess due to its proximity to CNS (risk of invasion) as the penetration of dalbavancin into the CNS has not been sufficiently studied 4. Have infected implants/prosthetic devices, unless the management includes removal of infected foreign material 5. Complicated left-sided endocarditis meeting criteria for early surgical intervention based on current Infectious Disease Society of America (IDSA) guidelines for management of infective endocarditis (https://www.idsociety.org/globalassets/idsa/practice-guidelines/infective-endocarditis-in-adults-diagnosis-antimicrobial-therapy-and-management-of-complications.pdf) 6. Have a significant psychiatric or cognitive deficit which does not meet the criteria for inpatient psychiatric hospitalization but which would, nevertheless, preclude meaningful engagement in substance use disorder treatment and infectious disease follow up 7. Are incarcerated 8. Have any other condition or abnormality that in the opinion of the investigators would compromise the safety of the patient or the quality of the data may will also be considered as a criterion for exclusion 9. Need long-term suppression with antibiotics after completion of the IV course, as this would render their follow up data uninterpretable from the infectious disease perspective (i.e. hardware associated osteoarticular infections) 10. Pregnant women (though no contraception will be required to prevent pregnancy during the study, as dalbavancin is not contraindicated in pregnancy in its Food and Drug Administration (FDA) approved indication; the exclusion aims to prevent dalbavancin use in patients with less predictable pharmacokinetic/pharmacodynamic (PK/PD) which is known to occur in pregnancy) 11. Patients with creatinine clearance (CrCl) \<30mL/min and those with end-stage renal disease (ESRD) on any renal replacement therapy

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 11, 'type': 'ACTUAL'}}

2023-10-19