Tolerability, Safety, and Efficacy of Tedizolid as Oral Treatment for Bone and Joint Infections (OTTER)

NCT03009045 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 21814-01
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

Brief Summary

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. This problem will be studied by investigating whether an antibiotic called tedizolid is tolerable, safe and effective to treat bone and joint infections.

Conditions

Bone and Joint Infection

Keywords

bone and joint infection; osteomyelitis; tedizolid

Outcome Measures

Primary Outcomes (2)

• Quantify the Tolerability of Tedizolid for Bone and Joint Infections, Both Hardware and Non-hardware Associated

  Tolerability was measured by interview. We asked participants weekly about new symptoms that could suggest new onset of peripheral or optic neuropathy.

  4-12 Weeks

• Quantify the Safety of Tedizolid for Bone and Joint Infections, Both Hardware and Non-hardware Associated

  Safety, was measured by weekly complete blood counts (CBC), and comprehensive metabolic panels (CMP) were performed.

  4-12 Weeks

Other Outcomes (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.

  16-24 Weeks

Study Arms (1)

Drug: 200mg oral Tedizolid

EXPERIMENTAL

200mg oral tablet of tedizolid to be taken once daily

Drug: Tedizolid

Interventions

Tedizolid DRUG

200mg oral tedizolid one pill per day

Also known as: tedizolid phosphate, Sivextro

Drug: 200mg oral Tedizolid

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Treatment of bone and joint infection in which therapy for Gram positive organisms is documented or suspected, as determined by the treating physician and treatment of at least 4 weeks is planned. Bone and joint infection and trauma-associated bone and joint infection will defined clinically using radiologic (e.g., MRI) and/or surgical (e.g., intra-operative findings) definitions. All subjects must have confirmation (diagnosis mentioned in chart) by the patient's primary physician and consultants that the patients has or likely has bone and joint infection and requires prolonged antibiotic therapy.
• Aged between 18 years and 85 years.
• Plans to treat bone and joint infection in outpatient setting.
• No limited planned course of antibiotics (i.e., no indefinite treatment plans for chronic suppression). Co-administration of other antibiotics that target other causative or potentially causative organisms (e.g., fluoroquinolones) is acceptable.
• Able to come to the research clinic for study follow-up visits for the study period.

You may not qualify if:

• Planned prolonged hospitalization (\> 1 week).
• Pregnancy (all female subjects of childbearing age will be given a pregnancy test prior to enrollment) or breast feeding. If a women is of childbearing potential, she must consistently use an acceptable method of contraception (IUD, injectable contraceptive, birth control patch, OCP, barrier method, abstinence) from baseline through the course of antibiotics (4-12 weeks). If a male patient's sexual partner is of childbearing potential, the male patient must acknowledge that they will consistently use an acceptable method of contraception as defined above from baseline through the course of antibiotics (4-12 weeks).
• Comorbidities that, in the opinion of the investigator, are uncontrolled (e.g., diabetes, hypertension, psychiatric disease).
• Peripheral or optic neuropathy.
• Hemoglobin (Hgb) \< 8.0g/dL
• WBC \< 4,000 k/cumm
• Platelets \< 150,000 k/cumm
• Severe hepatic dysfunction as defined by liver function tests (ALT, ALP, AST, total bilirubin) \> 3.0 times the upper limit of normal. as determined by the following limits from a baseline CMP obtained within the past 7 days. If a CMP has not been performed within the past 7 days, baseline levels may be used from a CMP performed within the past 2 months as long as another CMP is performed on the day of enrollment and the subject's levels are within the following limits.
• Hypersensitivity to tedizolid or other oxazolidinone-class antibiotics or similar compounds.
• Ongoing antibiotic-associated colitis.
• A diet high in tyramine-containing foods such as pickled or fermented meats and cheeses, wine, or avocados per investigator discretion.
• Concurrent use of sodium picosulfate (brand names: Sodipic Picofast, Laxoberal, Laxoberon, Purg-Odan, Picolax, Guttalax, Namilax, Pico-Salax and Prepopik).
• Previous participation in the study.
• Use of tedizolid for any condition in the past 3 months.
• Any other medical, psychological, or social condition that, in the opinion of the Investigator, would prevent the patient from fully participating in the study or would represent a concern for study compliance or constitute a safety concern to the patient.

Sponsors & Collaborators

• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center: lead

Study Sites (2)

Harbor-UCLA Medical Center

Torrance, California, 90502, United States

Location

Los Angeles BioMedical Research Institute (LA BioMed)

Torrance, California, 90502, United States

Location

Related Publications (1)

• Miller LG, Flores EA, Launer B, Lee P, Kalkat P, Derrah K, Agrawal S, Schwartz M, Steele G, Kim T, Kuvhenguhwa MS. Safety and tolerability of tedizolid as oral treatment for bone and joint infections. Microbiol Spectr. 2023 Sep 26;11(5):e0128223. doi: 10.1128/spectrum.01282-23. Online ahead of print.

  PMID: 37750695 DERIVED

MeSH Terms

Conditions

Osteomyelitis

Interventions

tedizolid; tedizolid phosphate

Condition Hierarchy (Ancestors)

Bone Diseases, Infectious; Infections; Bone Diseases; Musculoskeletal Diseases

Results Point of Contact

• Title: Loren G. Miller
• Organization: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

lgmiller@ucla.edu

310-222-5623

Study Officials

• Loren G Miller, MD MPH

  Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator, Associate Chief of Division of Infectious Diseases

Study Record Dates

• First Submitted: December 21, 2016
• First Posted: January 4, 2017
• Study Start: February 6, 2017
• Primary Completion: March 23, 2021
• Study Completion: August 6, 2021
• Last Updated: December 13, 2023
• Results First Posted: December 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

US (2)