Patients Response to Early Switch To Oral:Osteomyelitis Study (PRESTO:Osteo)
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|ClinicalTrials.gov Identifier: NCT02099240|
Recruitment Status : Unknown
Verified March 2018 by Julio Ramirez, University of Louisville.
Recruitment status was: Recruiting
First Posted : March 28, 2014
Last Update Posted : March 8, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Osteomyelitis||Drug: oral antibiotics Procedure: intravenous antibiotics||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||456 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Randomized Study to Compare Clinical Outcomes in Patients With Osteomyelitis Treated With Intravenous Antibiotics Versus Intravenous Antibiotics With an Early Switch to Oral Antibiotics|
|Study Start Date :||April 2014|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||September 2019|
Active Comparator: Intravenous antibiotics
Intravenous antibiotics for the full duration of therapy
Procedure: intravenous antibiotics
intravenous antibiotics for the full duration of therapy, antibiotic type will be dependent on bacteria type
Active Comparator: oral antibiotics
intravenous antibiotic therapy plus early switch to oral antibiotic therapy
Drug: oral antibiotics
intravenous antibiotics with early switch to oral antibiotics, antibiotic type will be dependent on bacteria type
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02099240
|United States, Kentucky|
|University of Louisville||Recruiting|
|Louisville, Kentucky, United States, 40202|
|Contact: Julio A Ramirez, MD 502-852-1148 firstname.lastname@example.org|
|Contact: David Seligson, MD 502-852-0923 email@example.com|
|Sub-Investigator: Forest Arnold, DO|
|Sub-Investigator: Timothy Wiemkwn, PhD|
|Sub-Investigator: Robert Kelley, PhD|
|Sub-Investigator: James Summersgill, PhD|
|Sub-Investigator: Ruth Carrico, PhD|
|Sub-Investigator: Julie Harting, PharmD|
|Sub-Investigator: Paula Peyrani, MD|
|Principal Investigator: David Seligson, MD|
|Sub-Investigator: Craig Roberts, MD|
|Principal Investigator: Julio Ramirez, MD|
|Principal Investigator:||David Seligson, MD||University of Louisville|
|Principal Investigator:||Julio Ramirez, MD||University of Louisville|