Trial Outcomes & Findings for Safety and Efficacy of Dalbavancin Versus Active Comparator in Adult Patients With Osteomyelitis (NCT NCT03091439)

Results Overview

Clinical response can be either cure, failure, or indeterminate. Cure was defined as recovery without need for additional antibiotic therapy. Failure was defined as the requirement of additional antibiotic therapy, new purulence, amputation due to progression of infection, requiring \> 6 weeks of treatment in the SOC arm or death (for any reason). Indeterminate was defined as lost to follow-up or amputation due to vascular insufficiency. The number of participants in each response category is reported.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

Day 42

Results posted on

2018-09-26

Participant Flow

Although this was a planned multi-center study, the study was terminated and only one investigative site in the United States enrolled a participant.

Participant milestones

Participant milestones
Measure	Dalbavancin Participants received Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1 and on Day 8.	Standard of Care Participants received an antibiotic consistent with standard of care (SOC) for osteomyelitis based on Investigator judgment. The duration of treatment was 4-6 weeks.
Overall Study STARTED	1	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Dalbavancin Participants received Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1 and on Day 8.	Standard of Care Participants received an antibiotic consistent with standard of care (SOC) for osteomyelitis based on Investigator judgment. The duration of treatment was 4-6 weeks.
Overall Study Study Terminated by the Sponsor	1	0

Baseline Characteristics

Safety and Efficacy of Dalbavancin Versus Active Comparator in Adult Patients With Osteomyelitis

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: Day 42

Population: CE population included all participants in the mITT Population who received ≥ 1 dose of dalbavancin or ≥ 2 weeks of comparator and ≤ 1 dose of another (non-study) systemic antibiotic with activity against the causative organism for an indication other than osteomyelitis. No participants were enrolled in the SOC arm.

Clinical response can be either cure, failure, or indeterminate. Cure was defined as recovery without need for additional antibiotic therapy. Failure was defined as the requirement of additional antibiotic therapy, new purulence, amputation due to progression of infection, requiring \> 6 weeks of treatment in the SOC arm or death (for any reason). Indeterminate was defined as lost to follow-up or amputation due to vascular insufficiency. The number of participants in each response category is reported.

Outcome measures

Outcome measures
Measure	Dalbavancin n=1 Participants Participants received Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1 and on Day 8.	Standard of Care Participants received an antibiotic consistent with standard of care (SOC) for osteomyelitis based on Investigator judgment. The duration of treatment was 4-6 weeks.
Number of Participants With Clinical Response at Day 42 in the Clinically Evaluable (CE) Population Cure	1 Participants	0 Participants
Number of Participants With Clinical Response at Day 42 in the Clinically Evaluable (CE) Population Failure	0 Participants	0 Participants
Number of Participants With Clinical Response at Day 42 in the Clinically Evaluable (CE) Population Indeterminate	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (Day 0) to Day 28

Population: mITT population including all randomized participants who received randomized medication and met criteria for known or suspected Gram-positive osteomyelitis. Participants from whom only a Gram-negative pathogen was isolated from blood and/or bone culture were excluded. No participants were enrolled in the SOC arm.

Clinical improvement was based on an assessment of pain and/or point tenderness compared to Baseline and assessment of inflammation as measured by C-reactive Protein (CRP). Clinical improvement was defined as no worsening of pain from Baseline, if present, and improvement in inflammation.

Outcome measures

Outcome measures
Measure	Dalbavancin n=1 Participants Participants received Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1 and on Day 8.	Standard of Care Participants received an antibiotic consistent with standard of care (SOC) for osteomyelitis based on Investigator judgment. The duration of treatment was 4-6 weeks.
Number of Participants With Clinical Improvement at Day 28 in the Modified Intent-to-Treat (mITT) Population	1 Participants	—

SECONDARY outcome

Timeframe: Baseline (Day 0) to Day 28

Population: CE population included all participants in the mITT Population who received ≥ 1 dose of dalbavancin or ≥ 2 weeks of comparator and ≤ 1 dose of another (non-study) systemic antibiotic with activity against the causative organism for an indication other than osteomyelitis. No participants were enrolled in the SOC arm.

Clinical improvement was based on an assessment of pain and/or point tenderness compared to Baseline and assessment of inflammation as measured by C-reactive Protein (CRP). Clinical improvement was defined as no worsening of pain from Baseline, if present, and improvement in inflammation.

Outcome measures

Outcome measures
Measure	Dalbavancin n=1 Participants Participants received Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1 and on Day 8.	Standard of Care Participants received an antibiotic consistent with standard of care (SOC) for osteomyelitis based on Investigator judgment. The duration of treatment was 4-6 weeks.
Number of Participants With Clinical Improvement at Day 28 in the CE Population	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 42

Population: mITT population included all randomized participants who received randomized medication and met the criteria for known or suspected Gram-positive osteomyelitis. Participants from whom only a Gram-negative pathogen was isolated from blood and/or bone culture were excluded. No participants were enrolled in the SOC arm.

Clinical response can be either cure, failure, or indeterminate. Cure was defined as recovery without need for additional antibiotic therapy. Failure was defined as the requirement of additional antibiotic therapy, new purulence, amputation due to progression of infection, requiring \> 6 weeks of treatment in the SOC arm or death (for any reason). Indeterminate was defined as lost to follow-up or amputation due to vascular insufficiency.

Outcome measures

Outcome measures
Measure	Dalbavancin n=1 Participants Participants received Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1 and on Day 8.	Standard of Care Participants received an antibiotic consistent with standard of care (SOC) for osteomyelitis based on Investigator judgment. The duration of treatment was 4-6 weeks.
Number of Participants With Clinical Response at Day 42 in the mITT Population Cure	1 Participants	0 Participants
Number of Participants With Clinical Response at Day 42 in the mITT Population Failure	0 Participants	0 Participants
Number of Participants With Clinical Response at Day 42 in the mITT Population Indeterminate	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 42

Population: micro-mITT included participants in the mITT Population with a Gram-positive pathogen isolated from blood and/or bone specimen. No participants met criteria for the micro-mITT population.

Clinical response can be either cure, failure, or indeterminate. Cure was defined as recovery without need for additional antibiotic therapy. Failure was defined as the requirement of additional antibiotic therapy, new purulence, amputation due to progression of infection, requiring \> 6 weeks of treatment in the SOC arm or death (for any reason). Indeterminate was defined as lost to follow-up or amputation due to vascular insufficiency.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 180

Population: Due to early termination of the study prior to the Day 180 visit, the participant enrolled did not have data collected for this visit, but did have an early termination visit prior to Day 180.

Clinical response can be either cure, failure, or indeterminate. Cure was defined as recovery without need for additional antibiotic therapy. Failure was defined as the requirement of additional antibiotic therapy, new purulence, amputation due to progression of infection, requiring \> 6 weeks of treatment in the SOC arm or death (for any reason). Indeterminate was defined as lost to follow-up or amputation due to vascular insufficiency.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 365

Population: Due to early termination of the study prior to the Day 180 visit, the participant enrolled did not have data collected for the visits at Day 180 or Day 365, but did have an early termination visit prior to Day 180.

Clinical response can be either cure, failure, or indeterminate. Cure was defined as recovery without need for additional antibiotic therapy. Failure was defined as the requirement of additional antibiotic therapy, new purulence, amputation due to progression of infection, requiring \> 6 weeks of treatment in the SOC arm or death (for any reason). Indeterminate was defined as lost to follow-up or amputation due to vascular insufficiency.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 42

Population: There were no pathogens identified in this study; the participant enrolled had no pathogens detected on blood culture, and the optional bone biopsy was not performed.

Clinical response can be either cure, failure, or indeterminate. Cure was defined as recovery without need for additional antibiotic therapy. Failure was defined as the requirement of additional antibiotic therapy, new purulence, amputation due to progression of infection, requiring \> 6 weeks of treatment in the SOC arm or death (for any reason). Indeterminate was defined as lost to follow-up or amputation due to vascular insufficiency.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 180

Population: There were no pathogens identified in this study; the participant enrolled had no pathogens detected on blood culture, and the optional bone biopsy was not performed.

Clinical response can be either cure, failure, or indeterminate. Cure was defined as recovery without need for additional antibiotic therapy. Failure was defined as the requirement of additional antibiotic therapy, new purulence, amputation due to progression of infection, requiring \> 6 weeks of treatment in the SOC arm or death (for any reason). Indeterminate was defined as lost to follow-up or amputation due to vascular insufficiency.

Outcome measures

Outcome data not reported

Adverse Events

Dalbavancin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Therapeutic Area Head

Allergan

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review.
Publication restrictions are in place

Restriction type: OTHER