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.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
29
Orthopedic Trauma Institute, University of California San Francisco
San Francisco, California, United States
UCSF - Parnassus
San Francisco, California, United States
LifeBridge Health, Inc.
Baltimore, Maryland, United States
OhioHealth Research Institute
Columbus, Ohio, United States
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.
Time frame: 12 weeks
Number of Treatment Failures
Treatment failure is defined as clinical course requiring additional infection-related interventions including rehospitalization, additional surgery, or additional courses of systemic antibiotics.
Time frame: 12 weeks
Treatment Failure in Subjects With Antibiotic-resistant Infections
Treatment failure in subjects with baseline infections resistant to one or more antibiotics based on Central Laboratory Microbiological data
Time frame: Up to 12weeks
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University of Pennsylvania
Philadelphia, Pennsylvania, United States
The University of Texas - Health Science Center & Medical School at Houston
Houston, Texas, United States