Postoperative orthopedic infections, particularly antibiotic-resistant infections, present a serious clinical challenge to surgeons and other treating physicians, since these infections involve surgically installed orthopedic hardware which are frequently associated with persistent microbial biofilms.1 Surgical intervention, irrigation, debridement and potential replacement of orthopedic hardware, combined with a prolonged course of systemic antibiotics (i.e. antibiotics taken intravenously or orally), is the standard of care for postoperative infections.2,3 However, outcomes associated with these infections are often poor including: chronic/recurrent infections; repeated hospitalizations; repeated surgeries; multiple courses of systemic antibiotic treatment; loss of function; disability; amputation; and death.4 Bacteria are able to adhere to foreign, implanted objects almost immediately, which can lead to rapid formation of microbial biofilms that drastically increase the resistance of wound-associated bacteria and contribute significantly to persistence and virulence of the infection.5,6
Locally administered MBN-101, an investigational therapy, with its dual antimicrobial and anti-biofilm effects may provide important potential advantages over current standard of care treatment for orthopedic infections. The combined effect of locally applied MBN-101 along with IV administered antibiotics, is expected to improve bacteria and biofilm eradication from postoperative orthopedic site of infection, compared to IV antibiotics alone. Ineffective treatment may result in: repeat surgeries; additional rounds of systemic antibiotics; additional patient hospitalization time; and increased morbidity and mortality.
MBN-101-201 Orthopedic Infection Study
A phase 2a clinical study to assess MBN-101 administered intraoperatively to osteosynthesis or osteomyelitis sites for patients diagnosed with an orthopedic infection, with or without orthopaedic hardware, is currently ongoing. The main objective of this study is to evaluate the safety and tolerability of single escalating doses of locally administered MBN-101 as adjunct to standard of care antimicrobial and surgical therapy.
Additional information about the study can be found here:
Qualified Infectious Disease Product (QIDP) designation and Fast Track status was granted by the US FDA for post-surgical implant infections.
- Hetrick EM and Schoenfisch MH. Reducing implant-related infections: active release strategies. Chem Soc Rev. 2006;35(9):780-789.
- Schmidt AH and Swiontkowski MF. Pathophysiology of infections after internal fixation of fractures. J Am Acad Orthop Surg. 2000;8(5):285-291.
- Patzakis MJ and Zalavras CG. Chronic posttraumatic osteomyelitis and infected nonunion of the tibia: current management concepts. J Am Acad Orthop Surg. 2005;13(6):417-427.
- Berkes M et al. Maintenance of hardware after early postoperative infection following fracture internal fixation. J Bone Joint Surg Am. 2010;92(4):823-828.
- Parra-Ruiz J et al. Macrolides and staphylococcal biofilms. Rev Esp Quimioter. 2012;25(1):10-16.
- Gristina AG et al. The glycocalyx, biofilm, microbes, and resistant infection. Semin Arthroplasty. 1994;5(4):160-170.