Tolerability, Safety, and Efficacy of Tedizolid as Oral Treatment for Bone and Joint Infections
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|ClinicalTrials.gov Identifier: NCT03009045|
Recruitment Status : Recruiting
First Posted : January 4, 2017
Last Update Posted : May 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Bone and Joint Infection||Drug: Tedizolid||Phase 2|
The problem of interest is that doctors are looking for new antibiotic treatments for bone and joint infections. Treatment for bone and joint infection is not standardized, which allows a wide range of antibiotic therapy to potentially be given. A type of bacteria called S. aureus is the most common cause of bone and joint infection. Methicillin resistant S. aureus (MRSA) is a type of bacteria that is not killed by some antibiotics, and it is increasingly common in U.S. and non-U.S. medical centers. Trauma-associated bone and joint infection is also a common problem. Victims of major trauma often suffer bone fractures, which require temporary or permanent use of metal or other synthetic devices such as external-fixation pins, plates, and screws. These synthetic devices can also get infected and cause bone and joint infections.
This problem will be studied by investigating whether an antibiotic called tedizolid is tolerable, safe and effective to treat bone and joint infections. Tedizolid is a new FDA-approved antibiotic, and can be given through the bloodstream via an IV or orally in the form of a pill. Tedizolid has less side effects compared to linezolid and is effective against types of bacteria like S. aureus. Other research also suggests that the side effects associated with long-term therapy of older types of antibiotics may not be found with tedizolid.
This study will advance scientific knowledge of antibiotic treatments for bone and joint infections. Given the large and increasing burden of disease of bone and joint infection and the increasing acceptability of oral antibiotics for its management, tedizolid holds promise as a good option for patients with bone and joint infection. Harbor-UCLA Medical Center is a large medical center in the County of Los Angeles, the most populous County in the United States. The Infectious Disease consult service sees many bone and joint infections. Use of prolonged antibiotics is common in this setting. The investigators believe tedizolid addresses the unmet need for an oral antibiotic that is well-tolerated and efficacious for use as a prolonged therapy for bone and joint infection.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Tolerability, Safety, and Efficacy of Tedizolid as Oral Treatment for Bone and Joint Infections|
|Actual Study Start Date :||February 6, 2017|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||January 2019|
Experimental: Drug: 200mg oral Tedizolid
200mg oral tablet of tedizolid to be taken once daily
200mg oral tedizolid one pill per day
- Number of "moderate" or "serious" adverse events as assessed by MedDRA v18.1 [ Time Frame: 4-12 Weeks ]Study Hypothesis: Tedizolid is well tolerated for prolonged (4-12 weeks)courses of antibiotic therapy for patients with bone and joint infection. Comprehensive Chemistry Panels including liver function tests (CMP) and Complete Blood Count (CBC) Panels will be collected at regular intervals along with standardized surveys to measure adverse events as defined by the Medical Dictionary for Regulatory Activities Terminology (MedDRA) Version 18.1
- Number of participants with an outcome of "cure" as defined as no need for further antibiotics beyond the originally planned duration determined by the participant's primary/treating physician. [ Time Frame: 4-12 Weeks ]Study Hypothesis: Tedizolid is effective for the treatment of bone and joint infection. Specifically, cure will be defined as no need for further antibiotics beyond the originally planned duration (i.e., 6 weeks for non-device associated bone and joint infection or until hardware removal for subjects with implants). Unplanned surgical procedures prompted by inadequate infection control will be categorized as treatment failure. We will also measure long-term efficacy by performing a phone survey 3 months after completion of antibiotics. Recurrence of signs or symptoms of bone and joint infection will be considered a long-term treatment failure.
- Number of participants with treatment-related adverse events as assessed by MedDRA v18.1 [ Time Frame: 4-12 weeks ]Study Hypothesis: Tedizolid is safe for prolonged (4-12 weeks) courses of antibiotic therapy for patients with bone and joint infection. Comprehensive Chemistry Panels including liver function tests (CMP) and Complete Blood Count (CBC) Panels will be collected at regular intervals along with standardized surveys to measure adverse events as defined by the Medical Dictionary for Regulatory Activities Terminology (MedDRA) Version 18.1
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): NCT03009045
|Contact: Loren G Miller, MD MPH||(310) email@example.com|
|Contact: Evelyn A Flores, BS||(310) 803-5819 ext firstname.lastname@example.org|
|United States, California|
|Harbor-UCLA Medical Center||Recruiting|
|Torrance, California, United States, 90502|
|Los Angeles BioMedical Research Institute (LA BioMed)||Recruiting|
|Torrance, California, United States, 90502|
|Principal Investigator:||Loren G Miller, MD MPH||Los Angeles Biomedical Research Institute|