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Dalbavancin For The Treatment of Gram Positive Osteoarticular Infections

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ClinicalTrials.gov Identifier: NCT03426761
Recruitment Status : Recruiting
First Posted : February 8, 2018
Last Update Posted : February 8, 2018
Sponsor:
Collaborator:
Johns Hopkins University
Information provided by (Responsible Party):
Infectious Diseases Physicians, Inc.

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.

Condition or disease Intervention/treatment Phase
Bone Infection Osteomyelitis Septic Arthritis Joint Infection Prosthetic Joint Infection Drug: Dalbavancin Drug: Vancomycin Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:

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

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dalbavancin For The Treatment Of Gram Positive Osteomyelitis Or Joint Infections Including Prosthetic Hip Or Knee Infections
Actual Study Start Date : January 25, 2018
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : January 2021


Arm Intervention/treatment
Experimental: Dalbavancin
Dalbavancin 1,500mg intravenously every fourteen days for two to four infusions
Drug: Dalbavancin
Dalbavancin 1,500mg intravenously every fourteen days for two to four infusions
Other Names:
  • Dalvance
  • Xydalba
  • Zevan

Active Comparator: Standard of Care
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
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
Other Names:
  • Daptomycin
  • Nafcillin
  • Cefazolin




Primary Outcome Measures :
  1. Clinical response (non-failure) to assigned treatment at day #42 [ Time Frame: Evaluated 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.


Secondary Outcome Measures :
  1. Sustained Clinical Response at day #90 [ Time Frame: Evaluated at Day 90 ]
    This is defined as the absence of drainage, sinus tract formation, fever, cellulitis, infectious effusion (culture +) or joint instability.

  2. Sustained Clinical Response at day #180 [ Time Frame: Evaluated at Day 180 ]
    This is defined as the absence of drainage, cellulitis, infectious effusion (culture +) or joint instability.

  3. Sustained Clinical Response at day #365 [ Time Frame: Evaluated at Day 365 ]
    This is defined as the absence of drainage, cellulitis, infectious effusion (culture +) or joint instability.

  4. CRP Improvement at day #90 [ Time Frame: Evaluated at Day 90 ]
    Normalized or, at least 75% reduction from baseline

  5. CRP Improvement at day #180 [ Time Frame: Evaluated at Day 180 ]
    Normalized or, at least 75% reduction from baseline

  6. CRP Improvement at day #365 [ Time Frame: Evaluated at Day 365 ]
    Normalized or, at least 75% reduction from baseline



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Male or female patients, aged 18-80, with the following osteoarticular infections:

    1. Infected shoulder, knee or hip (1st or 2nd episode) as defined by a diagnostic culture positive arthrocentesis
    2. 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
  3. 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
  4. If female, meet the following criteria:

    1. Not breastfeeding
    2. Not planning to become pregnant during the study
    3. Be surgically sterile, or at least 2-years postmenopausal, or have a negative pregnancy test at Baseline (Visit 1)
    4. 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
  5. Vision and hearing (hearing aid permissible) sufficient for compliance with testing procedures

Exclusion Criteria:

  1. Subjects with culture proven gram negative infection
  2. 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
  3. 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
  4. Current malignancy under treatment with chemotherapeutic agents
  5. 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)
  6. 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)
  7. HIV infection with a CD4 count <200
  8. Solid organ transplantation or bone marrow transplantation within 6 months
  9. History of severe neutropenia, defined as an absolute neutrophil count (ANC) <500 cells per microliter, in the last three months
  10. 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
  11. 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
  12. Positive test on a urine drug screening for drugs of abuse, for which the patient does not have prescription
  13. History of drug or alcohol abuse that, in the Investigator's medical judgment, would interfere with the conduct of the study
  14. History of hypersensitivity reaction to Dalbavancin or other drugs of the same class

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03426761


Contacts
Contact: Donald Poretz, MD 703-560-4821 donald2750@aol.com
Contact: David Wheeler, MD 703-560-4821 dwheel423@verizon.net

Locations
United States, Virginia
Infectious Diseases Physicians, Inc. Recruiting
Annandale, Virginia, United States, 22003
Contact: Donald Poretz, MD    703-560-4821    donald2750@aol.com   
Contact: David Wheeler, MD    703-560-4821    dwheel423@verizon.net   
Principal Investigator: Donald Poretz, MD         
Sub-Investigator: David Wheeler, MD         
Sponsors and Collaborators
Infectious Diseases Physicians, Inc.
Johns Hopkins University
Investigators
Principal Investigator: Donald Poretz, MD Infectious Diseases Physicians, Inc.

Additional Information:
Responsible Party: Infectious Diseases Physicians, Inc.
ClinicalTrials.gov Identifier: NCT03426761     History of Changes
Other Study ID Numbers: IIT-2017-10117
First Posted: February 8, 2018    Key Record Dates
Last Update Posted: February 8, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Upon conclusion of the statistical analysis, the study team may write their findings for an infectious disease journal article

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Infection
Communicable Diseases
Arthritis, Infectious
Osteomyelitis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Bone Diseases, Infectious
Bone Diseases
Vancomycin
Cefazolin
Daptomycin
Dalbavancin
Teicoplanin
Nafcillin
Anti-Bacterial Agents
Anti-Infective Agents