Trial Outcomes & Findings for Tolerability, Safety, and Efficacy of Tedizolid as Oral Treatment for Bone and Joint Infections (OTTER) (NCT NCT03009045)

NCT ID: NCT03009045

Last Updated: 2023-12-13

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 44 participants
• Primary outcome timeframe: 4-12 Weeks
• Results posted on: 2023-12-13

Participant Flow

Participant milestones

Measure	Drug: 200mg Oral Tedizolid 200mg oral tablet of tedizolid to be taken once daily Tedizolid: 200mg oral tedizolid one pill per day
Overall Study STARTED	44
Overall Study COMPLETED	37
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Drug: 200mg Oral Tedizolid n=37 Participants 200mg oral tablet of tedizolid to be taken once daily Tedizolid: 200mg oral tedizolid one pill per day
Age, Continuous	46 years n=5 Participants
Age, Customized Mean	44 years STANDARD_DEVIATION 14.0 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	23 Participants n=5 Participants
Race/Ethnicity, Customized White	2 Participants n=5 Participants
Race/Ethnicity, Customized Black/African American	10 Participants n=5 Participants
Race/Ethnicity, Customized Native American/Native Indian	1 Participants n=5 Participants
Race/Ethnicity, Customized Decline to State	1 Participants n=5 Participants
Region of Enrollment United States	37 participants n=5 Participants
Type of Bone or Joint Infection Hardware-associated infection	17 participants n=5 Participants
Type of Bone or Joint Infection Osteomyelitis, non-hardware associated	13 participants n=5 Participants
Type of Bone or Joint Infection Prosthetic joint infection	5 participants n=5 Participants
Type of Bone or Joint Infection External-fixator associated	1 participants n=5 Participants
Type of Bone or Joint Infection Septic arthritis	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 4-12 Weeks

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

Outcome measures

Measure	Drug: 200mg Oral Tedizolid n=37 Participants 200mg oral tablet of tedizolid to be taken once daily Tedizolid: 200mg oral tedizolid one pill per day
Quantify the Tolerability of Tedizolid for Bone and Joint Infections, Both Hardware and Non-hardware Associated Reported peripheral neuropathy	0 participants
Quantify the Tolerability of Tedizolid for Bone and Joint Infections, Both Hardware and Non-hardware Associated Reported optic neuropathy	0 participants

PRIMARY outcome

Timeframe: 4-12 Weeks

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

Outcome measures

Measure	Drug: 200mg Oral Tedizolid n=37 Participants 200mg oral tablet of tedizolid to be taken once daily Tedizolid: 200mg oral tedizolid one pill per day
Quantify the Safety of Tedizolid for Bone and Joint Infections, Both Hardware and Non-hardware Associated High leukocytes	0 participants
Quantify the Safety of Tedizolid for Bone and Joint Infections, Both Hardware and Non-hardware Associated Low leukocytes	0 participants
Quantify the Safety of Tedizolid for Bone and Joint Infections, Both Hardware and Non-hardware Associated Low hemoglobin	0 participants
Quantify the Safety of Tedizolid for Bone and Joint Infections, Both Hardware and Non-hardware Associated Low plateltes	0 participants
Quantify the Safety of Tedizolid for Bone and Joint Infections, Both Hardware and Non-hardware Associated High AST	0 participants
Quantify the Safety of Tedizolid for Bone and Joint Infections, Both Hardware and Non-hardware Associated High ALT	0 participants
Quantify the Safety of Tedizolid for Bone and Joint Infections, Both Hardware and Non-hardware Associated High ALP	0 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 16-24 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 cure by performing a phone survey 3 months after completion of antibiotics. Recurrence of signs or symptoms of bone and joint infection will be considered not a long-term treatment cure (i.e., failure).

Outcome measures

Measure	Drug: 200mg Oral Tedizolid n=37 Participants 200mg oral tablet of tedizolid to be taken once daily Tedizolid: 200mg oral tedizolid one pill per day
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.	13 participants

Adverse Events

Drug: 200mg Oral Tedizolid

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Drug: 200mg Oral Tedizolid n=44 participants at risk 200mg oral tablet of tedizolid to be taken once daily Tedizolid: 200mg oral tedizolid one pill per day
Skin and subcutaneous tissue disorders Rash	4.5% 2/44 • 16 weeks to 24 weeks

Additional Information

Loren G. Miller

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Phone: 310-222-5623

Email: lgmiller@ucla.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place