Study to Assess Safety and Clinical Activity of Local MBN-101 in Treatment of Infected Bone Sites

• Status: Completed
• Trial end date: 2018-07-26
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Microbion Corporation
• Collaborators: Congressionally Directed Medical Research Programs; Medpace, Inc.; University of California, San Francisco; University of Pennsylvania

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