a study on Bacterial Infection
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.
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
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.
Bacterial Infection Osteosynthesis Complications Infection or Inflammation Orthopedic Device Fracture
Open to people ages 18 years to 75 years
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
We will not share your information with anyone other than the team in charge of this study. Submitting your contact information does not obligate you to participate in research.
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If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT02436876.
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