Clinical Trial: Patients Response to Early Switch To Oral:Osteomyelitis Study

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Prospective Randomized Study to Compare Clinical Outcomes in Patients With Osteomyelitis Treated With Intravenous Antibiotics Versus Intravenous Antibiotics With an Early

Brief Summary:

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.


Detailed Summary:

1.1. Background Information Osteomyelitis is a common disease associated with significant morbidity and high cost (1). The treatment of osteomyelitis can be challenging requiring prolonged administration of antibiotics and extensive surgical procedures. Even when the infection is treated, the relapse rate is as high as 20% (2). When a bone is infected, the local multiplication of bacteria produces a local inflammatory response with presence of neutrophils and macrophages with areas of microthrombi and avascular necrosis. If a significant area of avascular necrosis develops, a segment of the bone without any blood supply can become separated and form a sequestrum. Since infection of sequestrum occurs in most patients with osteomyelitis, it is considered that in addition to antibiotic treatment, the patient requires surgical intervention for removal of necrotic bone.

1.2. Scientific Rationale There is agreement regarding the minimal duration of antibiotic therapy for patients with osteomyelitis. Since an infected bone may take 3 to 4 weeks to re--‐ vascularize, the duration of therapy should be a minimum of 4 to 6 weeks of antibiotics. Because different organisms can cause osteomyelitis, the initial antibiotic therapy during hospitalization should include broad--‐spectrum antibiotics to cover the most likely organisms. As part of the initial management, a bone biopsy is regularly performed to identify the particular etiologic agent. Once the organism and its antimicrobial susceptibilities are known, the spectrum of antibiotic therapy is narrowed, and the antimicrobial therapy continues with an antibiotic that is targeted according to the susceptibility of the identified pathogen. Targeted antibiotic therapy in patients with osteomyelitis is usually performed after 3 to 5 days of broad spectrum antibiotics, since this is the time required by the microbiology depa
Sponsor: Julio Ramirez

Current Primary Outcome: Clinical Failures [ Time Frame: 1 month ]

Clinical failure will be defined as clinical or laboratory evidence of infection collected from the patient's medical record documents.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Evaluation of adverse events related to the use of antibiotics [ Time Frame: 1 month ]
    Antibiotic--‐related adverse events will be defined according to the Food and Drug Administration adverse events listed in the package insert of the antibiotic prescribed for each subject.
  • Cost of care from the hospital perspective [ Time Frame: 12 months ]
    Costs will be calculated from the hospital perspective and will include the costs of the antibiotic therapy, home healthcare (nursing--‐ and infusion--‐related), and length of hospital stay.


Original Secondary Outcome: Same as current

Information By: University of Louisville

Dates:
Date Received: March 18, 2014
Date Started: April 2014
Date Completion: September 2019
Last Updated: March 21, 2017
Last Verified: March 2017