Dalbavancin For The Treatment of Gram Positive Osteoarticular Infections

NCT03426761 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: IIT-2017-10117
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

Because of its prolonged terminal half-life, dalbavancin is an extremely attractive option in treating Gram-positive infections caused by S. aureus including MRSA, and streptococcal species. Systemic bacterial infections due to Staphylococci such as osteomyelitis and septic arthritis, are conditions which require prolonged IV therapy, typically for at least 3-6 weeks, though sometimes more. Due to dalbavancin's prolonged terminal half-life, it may offer the opportunity to substantially reduce costs and morbidity in native joint and prosthetic joint infections with one infusion every fourteen days until completion of therapy.

Conditions

Bone Infection; Osteomyelitis; Septic Arthritis; Joint Infection; Prosthetic Joint Infection

Outcome Measures

Primary Outcomes (1)

• Clinical response (non-failure) to assigned treatment at day #42

  This is defined as the absence of wound drainage, sinus tract formation, fever or joint instability at study day 42, without having switched or extended treatment for any reason. This will be reported as the % of participants from each treatment arm, who are determined to be a treatment responder.

  Evaluated at Day 42

Secondary Outcomes (6)

• Sustained Clinical Response at day #90

  Evaluated at Day 90

• Sustained Clinical Response at day #180

  Evaluated at Day 180

• Sustained Clinical Response at day #365

  Evaluated at Day 365

• CRP Improvement at day #90

  Evaluated at Day 90

• CRP Improvement at day #180

  Evaluated at Day 180

Study Arms (2)

Dalbavancin

EXPERIMENTAL

Dalbavancin 1,500mg intravenously every fourteen days for two to four infusions

Drug: Dalbavancin

Standard of Care

ACTIVE COMPARATOR

Standard of care intravenous antibiotic based on microbiology susceptibility testing. Infusions may be one to three times daily for three to eight weeks. Examples of standard of care include vancomycin, daptomycin, nafcillin, cefazolin.

Drug: Vancomycin

Interventions

Dalbavancin DRUG

Dalbavancin 1,500mg intravenously every fourteen days for two to four infusions

Also known as: Dalvance, Xydalba, Zevan

Dalbavancin

Vancomycin DRUG

Examples of standard of care arm; infusions one to three times per day depending on the antibiotic for a total of three to eight weeks

Also known as: Daptomycin, Nafcillin, Cefazolin

Standard of Care

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent obtained from the patient (if possible) or from either the caregiver or legally authorized representative (if different from the caregiver) before the initiation of any study specific procedures.
• Male or female patients, aged 18-80, with the following osteoarticular infections:
• Infected shoulder, knee or hip (1st or 2nd episode) as defined by a diagnostic culture positive arthrocentesis
• An infected prosthetic shoulder, knee or hip as defined by a diagnostic culture positive arthrocentesis, or intraoperative diagnosis of infection with positive culture; an infected prosthetic knee or hip (1st or 2nd episode). Preoperative diagnosis by diagnostic, culture positive arthrocentesis
• Demonstrated by a positive culture for one of the following gram positive organisms: Methicillin susceptible Staphyloccocus aureus, methicillin resistant Staphylococcus aureus, Streptococcus pyogenes, Group B streptococcus, Streptococcus anginosus group, Vancomycin susceptible Enterococcus faecalis
• If female, meet the following criteria:
• Not breastfeeding
• Not planning to become pregnant during the study
• Be surgically sterile, or at least 2-years postmenopausal, or have a negative pregnancy test at Baseline (Visit 1)
• If of childbearing potential, agree to be strictly abstinent, or practice 2 of the following effective methods of birth control throughout the study: systemic contraception (e.g., oral contraceptives of estrogen and progestin combinations); depot injection (e.g., Depo-Provera); contraceptive implant (e.g., Norplant, Implanon); transdermally delivered contraceptive (e.g., Ortho Evra); intrauterine device; vaginal contraceptive ring (e.g.,NuvaRing); diaphragm plus spermicide; cervical cap; or male condom plus spermicide; partner vasectomy at least 6 months prior to baseline
• Vision and hearing (hearing aid permissible) sufficient for compliance with testing procedures

You may not qualify if:

• Subjects with culture proven gram negative infection
• 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
• Any other conditions that, in the investigator's opinion, might indicate that the patient is unsuitable for the study, the exception is, if there is a history of such disease but the condition has been stable for at least more than 3 year(s) and the investigator determines that it would not interfere with the patient's participation in the study
• Current malignancy under treatment with chemotherapeutic agents
• Any unapproved concomitant medication excluded in section 6.3 that could not be discontinued or switched to an allowable alternative medication before the Baseline (Visit 2)
• Currently participating in or previously participated in an investigational study of Dalbavancin or treatment with an investigational product within 3 months or 5 half-lives, whichever is longer, of Screening (Visit 1)
• HIV infection with a CD4 count \<200
• Solid organ transplantation or bone marrow transplantation within 6 months
• History of severe neutropenia, defined as an absolute neutrophil count (ANC) \<500 cells per microliter, in the last three months
• History of severe liver disease, i.e. Child-Pugh Class C or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than five times the upper limit of normal (ULN), in the last three months
• Positive blood culture in the past 14 days, evidence of multiple sites of joint infection, or evidence of concomitant infections at other body sites related to bacteremia
• Positive test on a urine drug screening for drugs of abuse, for which the patient does not have prescription
• History of drug or alcohol abuse that, in the Investigator's medical judgment, would interfere with the conduct of the study
• History of hypersensitivity reaction to Dalbavancin or other drugs of the same class

Sponsors & Collaborators

• Infectious Diseases Physicians, Inc.: lead
• Johns Hopkins University: collaborator

Study Sites (1)

Infectious Diseases Physicians, Inc.

Annandale, Virginia, 22003, United States

Location

Related Links

• Infectious Diseases Physicians, Inc.

MeSH Terms

Conditions

Osteomyelitis; Arthritis, Infectious

Interventions

dalbavancin; Vancomycin; Daptomycin; Nafcillin; Cefazolin

Condition Hierarchy (Ancestors)

Bone Diseases, Infectious; Infections; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Lipopeptides; Lipids; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cephalosporins; Thiazines

Study Officials

• Donald Poretz, MD

  Infectious Diseases Physicians, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Since it's a pilot study, the sample size is fixed (n = 50). The sample size were not selected based on statistical criteria. However, we would need to know what would be the detectable effect size. ∆\^2=((z\_(α/2)+z\_β )\^2 (σ\_1\^2+σ\_2\^2 ))/n

Study Record Dates

• First Submitted: January 26, 2018
• First Posted: February 8, 2018
• Study Start: January 25, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: October 3, 2023

Record last verified: 2023-10

Locations

US (1)