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

NCT02436876 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: MBN-101-201W81XWH-12-2-0100
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Bacterial Infection

Keywords

Osteosynthesis; Complications; Infection or Inflammation; Orthopedic; Device; Fracture; Osteomyelitis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events

  This study evaluates the safety and tolerability of single escalating doses of locally administered MBN-101 or placebo, as adjunct to standard of care antimicrobial and surgical therapy.

  12 weeks

Secondary Outcomes (2)

• Number of Treatment Failures

  12 weeks

• Treatment Failure in Subjects With Antibiotic-resistant Infections

  Up to 12weeks

Study Arms (3)

Cohort 1

EXPERIMENTAL

Single, intra-wound local administration of MBN-101; dosage = 0.5 µg/cm2; randomized 3:1 with placebo

Drug: MBN-101; Other: Placebo

Cohort 2

EXPERIMENTAL

Single, intra-wound local administration of MBN-101; dosage = 1.5 µg/cm2; randomized 3:1 with placebo

Drug: MBN-101; Other: Placebo

Cohort 3

EXPERIMENTAL

Single, intra-wound local administration of MBN-101; dosage = 5.0 µg/cm2; randomized 3:1 with placebo

Drug: MBN-101; Other: Placebo

Interventions

MBN-101 DRUG

MBN-101 is a locally administered, anti-infective drug product

Also known as: MBN-101 Drug Product

Cohort 1; Cohort 2; Cohort 3

Placebo OTHER

The placebo is comprised of the vehicle/excipients used to formulate MBN-101, but does not contain the active pharmaceutical ingredient

Also known as: Diluent; Vehicle

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Microbion Corporation: lead
• University of Pennsylvania: collaborator
• University of California, San Francisco: collaborator
• Medpace, Inc.: collaborator
• Congressionally Directed Medical Research Programs: collaborator

Study Sites (6)

Orthopedic Trauma Institute, University of California San Francisco

San Francisco, California, 94110, United States

Location

UCSF - Parnassus

San Francisco, California, 94143, United States

Location

LifeBridge Health, Inc.

Baltimore, Maryland, 21215, United States

Location

OhioHealth Research Institute

Columbus, Ohio, 443215, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

The University of Texas - Health Science Center & Medical School at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Bacterial Infections; Infections; Inflammation; Fractures, Bone; Osteomyelitis

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries; Bone Diseases, Infectious; Bone Diseases; Musculoskeletal Diseases

Results Point of Contact

• Title: Brett Baker, President and Chief Innovation Officer
• Organization: Microbion Corporation

bbaker@microbioncorp.com

4065991190

Study Officials

• Brett Baker, MSc, DC

  Microbion Corporation

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2015
• First Posted: May 7, 2015
• Study Start: May 24, 2016
• Primary Completion: October 27, 2017
• Study Completion: July 26, 2018
• Last Updated: September 30, 2021
• Results First Posted: September 30, 2021

Record last verified: 2021-09

Locations

US (6)