Study to Assess Safety and Clinical Activity of Local MBN-101 in Treatment of Infected Bone Sites
Condition: Bacterial Infection
MeSH terms: Bacterial Infections
Intervention: MBN-101; Placebo
Intervention description: MBN-101 is a locally administered, anti-infective drug product; The placebo is comprised of the vehicle/excipients used to formulate MBN-101, but does not contain the active pharmaceutical ingredient
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Osteosynthesis; Complications; Infection or Inflammation; Orthopedic; Device; Fracture; Osteomyelitis

Summary:

      This study evaluates the safety and clinical benefit of MBN-101 administered intraoperatively
      to osteosynthesis or osteomyelitis sites for patients diagnosed with an orthopedic infection,
      with or without orthopaedic hardware. Three quarters of the patients will receive MBN-101,
      while the other one quarter will receive placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  To be eligible for this study, each of the following criteria must be satisfied with a
             "YES" answer (unless not applicable):

        Patients who:

          -  have had operative fracture fixation of the upper extremity (AO/OTA class 15, 11-13,
             21-23), lower extremity (AO/OTA class 31-34, 41 44, 81, 82) or pelvis (61, 62), or
             have undergone arthrodesis, and have subsequently been diagnosed with an apparent
             fracture site infection or are diagnosed with chronic or acute-on-chronic
             osteomyelitis of the long bone extremities (including residual amputated limbs)

          -  have at least one of the following:

          -  require surgical debridement of infected soft tissue and/or bone, with or without
             removal and/or placement/replacement of hardware

          -  male or female between the ages of 18 and 75 at the time the ICF is reviewed and
             signed

          -  patients receiving or anticipated to receive systemic antibiotic therapy as per
             institution's standard of care

          -  patients requiring postoperative hospitalization for at least 48 hours after revision
             surgery

          -  have read and signed the Informed Consent Form (ICF) after the nature of the study has
             been fully explained

          -  be willing and able to provide authorization for use and disclosure of personal health
             information in accordance with the Health Insurance Portability and Accountability Act
             (HIPAA)

        Exclusion Criteria:

          -  To be eligible for this study, each of the following criteria must be satisfied with a
             "NO" answer (unless not applicable):

               -  Patients who are no longer hardware dependent or are definitively treated for
                  their infection by hardware removal without replacement

               -  Patients with multiple, non-contiguous sites of infection

               -  Pathologic fracture (not including osteoporosis)

               -  Patient requires immunosuppressive therapy (Topical or inhaled corticosteroids
                  are permitted)

               -  Serum creatinine, ALT, AST or Alkaline Phosphatase >2.0 times the upper limit of
                  the normal range of the local testing laboratory

               -  Absolute neutrophil count <1000

               -  Patients without definitive soft-tissue coverage over the surgical site at time
                  of study product administration

               -  Any condition that has required treatment with any other bismuth containing
                  compound within the last 2 weeks (i.e., Kaopectate or Pepto Bismol)

               -  Participation in an investigational trial to evaluate pharmaceuticals or
                  biologics within the past 3 months

               -  Individuals undergoing surgical treatment for more than one infected site

               -  Patients who are pregnant, lactating, or female patients who have a positive
                  serum hCG (human Chorionic Gonadotropin) as determined by laboratory testing

               -  Immunocompromised due to illness or organ transplant

               -  History of chronic or recurrent infections (≥ 3 infections at the same site
                  within 12 months)

               -  History of any type of cancer (excluding non-melanomatous localized skin cancer
                  or completely excised and cured carcinoma-in-situ of uterine cervix)

               -  Poorly controlled diabetes mellitus

               -  History of medical noncompliance

               -  Other medical conditions which, in the opinion of the Principal Investigator,
                  would jeopardize the safety of the study subject or impact the validity of the
                  study results.

               -  Current incarceration