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Patients Response to Early Switch To Oral:Osteomyelitis Study

NCT02099240 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2021-04-06

No results posted yet for this study

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.

Conditions

  • Osteomyelitis

Interventions

DRUG

oral antibiotics

intravenous antibiotics with early switch to oral antibiotics, antibiotic type will be dependent on bacteria type

PROCEDURE

intravenous antibiotics

intravenous antibiotics for the full duration of therapy, antibiotic type will be dependent on bacteria type

Sponsors & Collaborators

  • University of Louisville

    collaborator OTHER

  • Julio Ramirez

    lead OTHER

Principal Investigators

  • David Seligson, MD · University of Louisville

  • Julio Ramirez, MD · University of Louisville

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-06
Primary Completion
2018-11-07
Completion
2018-11-07

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02099240 on ClinicalTrials.gov