Trial · NCT03091439

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

NCT03091439, Phase 2, Terminated, Allergan; results first posted 2018-09-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy of Dalbavancin Versus Active Comparator in Adult Patients With Osteomyelitis. Trials, record NCT03091439. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03091439

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety and Efficacy of Dalbavancin Versus Active Comparator in Adult Patients With Osteomyelitis
NCT number: NCT03091439
Status: Terminated
Phases: Phase 2
Enrollment: 1 participants, actual
Lead sponsor: Allergan
Conditions: Osteomyelitis
Interventions: Dalbavancin, Standard of Care
First posted: 2017-03-27
Last updated: 2018-09-26
Results first posted: 2018-09-26

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Clinical Response at Day 42 in the Clinically Evaluable (CE) Population	Day 42	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.
Secondary	Number of Participants With Clinical Improvement at Day 28 in the Modified Intent-to-Treat (mITT) Population	Baseline (Day 0) to Day 28	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.
Secondary	Number of Participants With Clinical Improvement at Day 28 in the CE Population	Baseline (Day 0) to Day 28	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.
Secondary	Number of Participants With Clinical Response at Day 42 in the mITT Population	Day 42	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.
Secondary	Number of Participants With Clinical Response at Day 42 in the Microbiological Modified Intent-to-Treat (Micro-mITT) Population	Day 42	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.
Secondary	Number of Participants With Clinical Response at Day 180 in the mITT and CE Populations	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.
Secondary	Number of Participants With Clinical Response at Day 365 in the mITT and CE Populations	Day 365	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.
Secondary	Number of Participants With Clinical Response by Pathogen at Day 42 in the CE Population	Day 42	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.
Secondary	Number of Participants With Clinical Response by Pathogen at Day 180 in the CE Population	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.

Source ClinicalTrials.gov

Outcomes9

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Clinical Response at Day 42 in the Clinically Evaluable (CE) Population	Day 42	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.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Clinical Improvement at Day 28 in the Modified Intent-to-Treat (mITT) Population	Baseline (Day 0) to Day 28	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.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Clinical Improvement at Day 28 in the CE Population	Baseline (Day 0) to Day 28	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.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Clinical Response at Day 42 in the mITT Population	Day 42	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.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Clinical Response at Day 42 in the Microbiological Modified Intent-to-Treat (Micro-mITT) Population	Day 42	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.
SECONDARY	Number of Participants With Clinical Response at Day 180 in the mITT and CE Populations	Day 180	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.
SECONDARY	Number of Participants With Clinical Response at Day 365 in the mITT and CE Populations	Day 365	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.
SECONDARY	Number of Participants With Clinical Response by Pathogen at Day 42 in the CE Population	Day 42	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.
SECONDARY	Number of Participants With Clinical Response by Pathogen at Day 180 in the CE Population	Day 180	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.

Source ClinicalTrials.gov

Results by group15

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Number of Participants With Clinical Response at Day 42 in the Clinically Evaluable (CE) Population	Dalbavancin	Cure	1	Participants
Number of Participants With Clinical Response at Day 42 in the Clinically Evaluable (CE) Population	Standard of Care	Cure	0	Participants
Number of Participants With Clinical Response at Day 42 in the Clinically Evaluable (CE) Population	Dalbavancin	Failure	0	Participants
Number of Participants With Clinical Response at Day 42 in the Clinically Evaluable (CE) Population	Standard of Care	Failure	0	Participants
Number of Participants With Clinical Response at Day 42 in the Clinically Evaluable (CE) Population	Dalbavancin	Indeterminate	0	Participants
Number of Participants With Clinical Response at Day 42 in the Clinically Evaluable (CE) Population	Standard of Care	Indeterminate	0	Participants
Number of Participants With Clinical Improvement at Day 28 in the Modified Intent-to-Treat (mITT) Population	Dalbavancin		1	Participants
Number of Participants With Clinical Improvement at Day 28 in the CE Population	Dalbavancin		1	Participants
Number of Participants With Clinical Improvement at Day 28 in the CE Population	Standard of Care		0	Participants
Number of Participants With Clinical Response at Day 42 in the mITT Population	Dalbavancin	Cure	1	Participants

1 to 10 of 15Source ClinicalTrials.gov

See all 15 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Dalbavancin	1
Overall Study	STARTED	Standard of Care	0
Overall Study	COMPLETED	Dalbavancin	0
Overall Study	COMPLETED	Standard of Care	0
Overall Study	NOT COMPLETED	Dalbavancin	1
Overall Study	NOT COMPLETED	Standard of Care	0

Source ClinicalTrials.gov

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals6

The totals the trial posted for each group.

Total	Group	At risk
Total, all-cause mortality	Dalbavancin	1
Total, all-cause mortality	Standard of Care	0
Total, other adverse events	Dalbavancin	1
Total, other adverse events	Standard of Care	0
Total, serious adverse events	Dalbavancin	1
Total, serious adverse events	Standard of Care	0

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03091439

GET https://conductscience.org/api/trials/v1/NCT03091439/registered

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