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Eligibility
for people ages 18 years to 75 years
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

Summary

This study evaluates the safety and clinical benefit of MBN-101 administered intraoperatively to infected osteosynthesis sites for patients diagnosed with a fracture site infection associated with orthopaedic hardware. Three quarters of the patients will receive MBN-101, while the other one quarter will receive placebo.

Official Title

Phase 2a Randomized, Single-Blind, Placebo-Controlled, 24-week Escalating Dose Study to Assess the Safety, Tolerability and Clinical Activity of 3 Concentrations of Locally Applied MBN-101 to Infected Osteosynthesis Sites

Details

Postoperative orthopaedic infections, particularly antibiotic-resistant infections, present a serious clinical challenge to surgeons and other treating physicians. These infections involve implanted foreign materials (stabilizing orthopaedic hardware), making infection of these sites much more likely than if foreign materials were not involved. MBN-101 has broad spectrum antimicrobial activity against orthopaedic wound pathogens.

This is a randomized, single-blind, placebo-controlled, multi-center study to assess the safety and tolerability of escalating doses of MBN-101 to treat infected osteosynthesis sites during revision surgery with or without hardware removal and replacement for patients diagnosed with an apparent fracture site infection within one year of the last surgical intervention.

Keywords

Bacterial Infection Osteosynthesis Complications Infection or Inflammation Orthopedic Device Fracture

Eligibility

You can join if…

Open to people ages 18 years to 75 years

  • 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 (Association of Osteoarthritis / Orthopedic Trauma Association) 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
  • are diagnosed with an apparent fracture site infection and have at least one of the following:

    Elevated ESR (Erythrocyte Sedimentation Rate) above the upper limit of normal; Elevated CRP (C-Reactive Protein) above the upper limit of normal; Draining wound / sinus tract;Positive culture from site of prior surgery by aspirate or other modality; Local erythema or induration at the site of prior surgery; Exposed hardware; Periosteal reaction on x-ray; Loose or broken hardware

  • require revision surgery with or without removal and replacement of existing 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 CAN'T join 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 fracture site infections
  • Pathologic fracture (not including osteoporosis)
  • Patient requires immunosuppressive therapy (Topical or inhaled corticosteroids are permitted)
  • Serum creatinine, ALT (Alanine Aminotransferase), AST (Aspartate Aminotransferase) or Alkaline Phosphatase>1.5 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 fracture
  • 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

Locations

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Microbion Corporation
ID
NCT02436876
Phase
Phase 2
Lead Scientist
Saam Morshed
Study Type
Interventional
Last Updated
February 2017
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