Osteomyelitis | Patients Response to Early Switch To Oral:Osteomyelitis Study
Osteomyelitis research study
What is the primary objective of this study?
Based on the current literature, investigators hypothesize that patients with osteomyelitis who are treated with the standard approach of intravenous antibiotics for the full duration of therapy will have the same clinical outcomes as patients treated with the experimental approach of intravenous antibiotics with early switch to oral antibiotics. The primary objective of this study is to compare patients with osteomyelitis treated with the standard approach of intravenous antibiotics for the full duration of therapy versus patients treated with intravenous antibiotics with an early switch to oral antibiotics in relation to clinical outcomes at 12 months after discontinuation of antibiotic therapy. Secondary objectives of the study include the evaluation of adverse events related to the use of antibiotics as well as the cost of care evaluated from the hospital perspective.
Who is eligible to participate?
Inclusion Criteria: - Only adult patients will be invited to participate in this trial (age ≥ 18 years). A patient will be considered a candidate to participate in this trial if the following two inclusion criteria are present: 1. Isolation of an organism from bone culture that is susceptible to intravenous and oral antibiotics. 2. Plus at least one of the following: - Evidence of local inflammatory response, manifested as local pain, edema, erythema, warmth, or drainage. - Evidence of systemic inflammatory response, manifested as fever, elevated C--‐reactive protein (CRP) level, erythrocyte sedimentation rate (ESR), or white blood cell count. - *Osteomyelitis--‐compatible findings on plain radiograph, computed tomography, bone scan, magnetic resonance imaging, or positron emission tomography. - Pathology report indicative of osteomyelitis. Exclusion Criteria: - A patient will not be considered as a candidate to participate in this study if the study team expects the subject to be non--‐compliant with the study follow--‐up clinic visit.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:oral antibioticsintravenous antibiotics with early switch to oral antibiotics, antibiotic type will be dependent on bacteria type
Procedure:intravenous antibioticsintravenous antibiotics for the full duration of therapy, antibiotic type will be dependent on bacteria type
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Intravenous antibioticsIntravenous antibiotics for the full duration of therapy
oral antibioticsintravenous antibiotic therapy plus early switch to oral antibiotic therapy
Start Date: April 2014
Completed Date: September 2019
Phase: Early Phase 1
Primary Outcome: Clinical Failures
Secondary Outcome: Evaluation of adverse events related to the use of antibiotics
Study sponsors, principal investigator, and references
Principal Investigator: David Seligson, MD
Lead Sponsor: Julio Ramirez
Collaborator: University of Louisville
Lew DP, Waldvogel FA. Osteomyelitis. Lancet. 2004 Jul 24-30;364(9431):369-79. Review.
Haas DW, McAndrew MP. Bacterial osteomyelitis in adults: evolving considerations in diagnosis and treatment. Am J Med. 1996 Nov;101(5):550-61. Review.
Waldvogel FA, Medoff G, Swartz MN. Osteomyelitis: a review of clinical features, therapeutic considerations and unusual aspects. N Engl J Med. 1970 Jan 22;282(4):198-206. Review.
Lazzarini L, Lipsky BA, Mader JT. Antibiotic treatment of osteomyelitis: what have we learned from 30 years of clinical trials? Int J Infect Dis. 2005 May;9(3):127-38. Review.
Conterno LO, da Silva Filho CR. Antibiotics for treating chronic osteomyelitis in adults. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD004439. doi: 10.1002/14651858.CD004439.pub2. Review. Update in: Cochrane Database Syst Rev. 2013;9:CD004439.
Peyrani P, Allen M, Seligson D, Roberts C, Chen A, Haque N, Zervos M, Wiemken T, Harting J, Christensen D, Ramirez R. Clinical outcomes of osteomyelitis patients infected with methicillin-resistant Staphylococcus aureus USA-300 strains. Am J Orthop (Belle Mead NJ). 2012 Mar;41(3):117-22.