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

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ClinicalTrials.gov Identifier: NCT02436876
Recruitment Status : Active, not recruiting
First Posted : May 7, 2015
Last Update Posted : August 13, 2018
Sponsor:
Collaborators:
University of Pennsylvania
University of California, San Francisco
Medpace, Inc.
Congressionally Directed Medical Research Programs
Information provided by (Responsible Party):
Microbion Corporation

Tracking Information
First Submitted Date  ICMJE April 28, 2015
First Posted Date  ICMJE May 7, 2015
Last Update Posted Date August 13, 2018
Study Start Date  ICMJE January 2016
Estimated Primary Completion Date September 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2015)
Number of Participants with Changes in Clinical Laboratory Tests, Vital Signs, Physical Exams, Electrocardiograms, Microbiology Status, Treatment Failures and/or Adverse Events as a composite to measure Safety and Tolerability [ Time Frame: 24 weeks ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02436876 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2015)
  • Number of Serious Interventions Required Post-Treatment to Eradicate Infection [ Time Frame: 24 weeks ]
    The cumulative number of serious interventions and treatment failures will be measured and compared to the placebo arm, following administration of MBN-101 or placebo, to evaluate the clinical activity of single, escalating doses of locally administered MBN-101.
  • Time to First Serious Intervention [ Time Frame: Up to 24 weeks ]
    Time to first necessary treatment intervention following administration of MBN-101 or placebo will be assessed.
  • Composite Pharmacokinetics of Single Escalating Doses of Locally Administered MBN-101 [ Time Frame: 1, 6, 12, 24, 36, 48, 60, 72, 96, and 336 hr post-dose ]
    Whole blood concentrations will be measured after administration of single escalating doses of MBN-101 and will be used to calculate pharmacokinetic parameters [i.e.:
    • Tmax (time of the maximum observed concentration)
    • Cmax (peak drug concentration)
    • AUC (area under the plasma-concentration time curve)
    • T1/2 (terminal half-life)
    • CL/F (extravascular clearance), and
    • Vz/F (extravascular volume of distribution)].
  • Time to Fracture Healing and Removal of Orthopedic Hardware Post-Treatment [ Time Frame: Up to 24 weeks ]
    Time to fracture healing and removal of orthopedic hardware will be measured to assess treatment efficacy
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Assess Safety and Clinical Activity of Local MBN-101 in Treatment of Infected Bone Sites
Official Title  ICMJE Phase 2a Randomized, Single-Blind, Placebo-Controlled, 12-week Escalating Dose Study to Assess the Safety, Tolerability and Clinical Activity of 3 Concentrations of Locally Applied MBN-101 to Infected Bone Sites
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.
Detailed Description

Postoperative orthopaedic infections, particularly antibiotic-resistant infections, present a serious clinical challenge to surgeons and other treating physicians. These infections frequently 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 orthopaedic infections during revision surgery, (a) with or without orthopaedic hardware, and (b) with or without removal and replacement of orthopaedic hardware.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Bacterial Infection
Intervention  ICMJE
  • Drug: MBN-101
    MBN-101 is a locally administered, anti-infective drug product
    Other Name: MBN-101 Drug Product
  • Other: Placebo
    The placebo is comprised of the vehicle/excipients used to formulate MBN-101, but does not contain the active pharmaceutical ingredient
    Other Name: Diluent; Vehicle
Study Arms  ICMJE
  • Experimental: Cohort 1
    Single, intra-wound local administration of MBN-101; dosage = 0.5 µg/cm2; randomized 3:1 with placebo
    Interventions:
    • Drug: MBN-101
    • Other: Placebo
  • Experimental: Cohort 2
    Single, intra-wound local administration of MBN-101; dosage = 1.5 µg/cm2; randomized 3:1 with placebo
    Interventions:
    • Drug: MBN-101
    • Other: Placebo
  • Experimental: Cohort 3
    Single, intra-wound local administration of MBN-101; dosage = 5.0 µg/cm2; randomized 3:1 with placebo
    Interventions:
    • Drug: MBN-101
    • Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 9, 2018)
25
Original Estimated Enrollment  ICMJE
 (submitted: May 6, 2015)
36
Estimated Study Completion Date  ICMJE December 31, 2018
Estimated Primary Completion Date September 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02436876
Other Study ID Numbers  ICMJE MBN-101-201
W81XWH-12-2-0100 ( Other Grant/Funding Number: CDMRP )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Microbion Corporation
Study Sponsor  ICMJE Microbion Corporation
Collaborators  ICMJE
  • University of Pennsylvania
  • University of California, San Francisco
  • Medpace, Inc.
  • Congressionally Directed Medical Research Programs
Investigators  ICMJE
Study Chair: Brett Baker, MSc, DC Microbion Corporation
PRS Account Microbion Corporation
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP