Patients Response to Early Switch To Oral:Osteomyelitis Study

Stopped early · Early Phase 1

Conditions studied: Osteomyelitis

In brief

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.

Key facts

Study ID

NCT02099240

Run by

Julio Ramirez

People needed

11

Starts

2014-03-06

Expected to finish

2018-11-07

Last updated by the study team

2021-04-06

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• Isolation of an organism from bone culture that is susceptible to intravenous and oral antibiotics.
• 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.

You may not qualify if…

• 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.

Where it is running

• University of Louisville — Louisville, Kentucky, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.