Trial · NCT02685033
Study on the Safety and Efficacy of Dalbavancin Versus Active Comparator in Adult Participants With Osteomyelitis
NCT02685033, Phase 2, Completed, Durata Therapeutics Inc., an affiliate of Allergan plc; results first posted 2019-01-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study on the Safety and Efficacy of Dalbavancin Versus Active Comparator in Adult Participants With Osteomyelitis. Trials, record NCT02685033. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02685033
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study on the Safety and Efficacy of Dalbavancin Versus Active Comparator in Adult Participants With Osteomyelitis
- NCT number
- NCT02685033
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 80 participants, actual
- Lead sponsor
- Durata Therapeutics Inc., an affiliate of Allergan plc
- Conditions
- Osteomyelitis
- Interventions
- Dalbavancin, Comparator
- First posted
- 2016-02-18
- Last updated
- 2019-01-04
- Results first posted
- 2019-01-04
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Clinical Response at Day 42 in the Clinically Evaluable (CE) Population | Day 42 | Clinical response was either cure, failure or indeterminate. A cure was defined as recovery without need for additional antibiotic therapy. A failure was defined as the requirement of additional antibiotic therapy for no response or worsening after improvement, new purulence, amputation due to progression of infection (from initiation of study drug to outcome assessment visit), requiring \>6 weeks of antibiotic therapy for participants in the standard of care arm or death (for any reason). Indeterminate was defined as lost to follow-up or amputation due to vascular insufficiency (from initiation of study drug to outcome assessment visit). |
| Primary | Percentage of Participants With Clinical Response at Day 365 in the CE Population | Day 365 | Clinical response was either cure, failure or indeterminate. A cure was defined as recovery without need for additional antibiotic therapy. A failure was defined as the requirement of additional antibiotic therapy for no response or worsening after improvement, new purulence, amputation due to progression of infection (from initiation of study drug to outcome assessment visit), requiring \>6 weeks of antibiotic therapy for participants in the standard of care arm or death (for any reason). Indeterminate was defined as lost to follow-up or amputation due to vascular insufficiency (from initiation of study drug to outcome assessment visit). |
| Secondary | Percentage of Participants With Clinical Improvement at Day 21 in the mITT Population | Baseline to Day 21 | Clinical improvement was defined as no worsening of pain from baseline, if present (subjective pain and/or point tenderness), and improvement in inflammation (as measured by C-reactive protein \[CRP\]). |
| Secondary | Percentage of Participants With Clinical Improvement at Day 21 in the CE Population | Baseline to Day 21 | Clinical improvement was defined as no worsening of pain from baseline, if present (subjective pain and/or point tenderness), and improvement in inflammation (as measured by C-reactive protein \[CRP\]). |
| Secondary | Percentage of Participants With Clinical Response at Day 42 in the mITT Population | Day 42 | Clinical response was either cure, failure or indeterminate. A cure was defined as recovery without need for additional antibiotic therapy. A failure was defined as the requirement of additional antibiotic therapy for no response or worsening after improvement, new purulence, amputation due to progression of infection (from initiation of study drug to outcome assessment visit), requiring \>6 weeks of antibiotic therapy for participants in the standard of care arm or death (for any reason). Indeterminate was defined as lost to follow-up or amputation due to vascular insufficiency (from initiation of study drug to outcome assessment visit). |
| Secondary | Percentage of Participants With Clinical Response at Day 42 in the Microbiological Modified Intent-to-Treat (Micro-mITT) Population | Day 42 | Clinical response was either cure, failure or indeterminate. A cure was defined as recovery without need for additional antibiotic therapy. A failure was defined as the requirement of additional antibiotic therapy for no response or worsening after improvement, new purulence, amputation due to progression of infection (from initiation of study drug to outcome assessment visit), requiring \>6 weeks of antibiotic therapy for participants in the standard of care arm or death (for any reason). Indeterminate was defined as lost to follow-up or amputation due to vascular insufficiency (from initiation of study drug to outcome assessment visit). |
| Secondary | Percentage of Participant With Clinical Response at Day 180 in the mITT Population | Day 180 | Clinical response was either cure, failure or indeterminate. A cure was defined as recovery without need for additional antibiotic therapy. A failure was defined as the requirement of additional antibiotic therapy for no response or worsening after improvement, new purulence, amputation due to progression of infection (from initiation of study drug to outcome assessment visit), requiring \>6 weeks of antibiotic therapy for participants in the standard of care arm or death (for any reason). Indeterminate was defined as lost to follow-up or amputation due to vascular insufficiency (from initiation of study drug to outcome assessment visit). |
| Secondary | Percentage of Participants With Clinical Response at Day 180 in the CE Population | Day 180 | Clinical response was either cure, failure or indeterminate. A cure was defined as recovery without need for additional antibiotic therapy. A failure was defined as the requirement of additional antibiotic therapy for no response or worsening after improvement, new purulence, amputation due to progression of infection (from initiation of study drug to outcome assessment visit), requiring \>6 weeks of antibiotic therapy for participants in the standard of care arm or death (for any reason). Indeterminate was defined as lost to follow-up or amputation due to vascular insufficiency (from initiation of study drug to outcome assessment visit). |
| Secondary | Percentage of Participants With Clinical Response at Day 365 in the mITT Population | Day 365 | Clinical response was either cure, failure or indeterminate. A cure was defined as recovery without need for additional antibiotic therapy. A failure was defined as the requirement of additional antibiotic therapy for no response or worsening after improvement, new purulence, amputation due to progression of infection (from initiation of study drug to outcome assessment visit), requiring \>6 weeks of antibiotic therapy for participants in the standard of care arm or death (for any reason). Indeterminate was defined as lost to follow-up or amputation due to vascular insufficiency (from initiation of study drug to outcome assessment visit). |
| Secondary | Number of Participants With Clinical Cure by Baseline Pathogen at Day 42 in the CE Population | Day 42 | Clinical response was either cure, failure or indeterminate. A cure was defined as recovery without need for additional antibiotic therapy. A failure was defined as the requirement of additional antibiotic therapy for no response or worsening after improvement, new purulence, amputation due to progression of infection (from initiation of study drug to outcome assessment visit), requiring \>6 weeks of antibiotic therapy for participants in the standard of care arm or death (for any reason). Indeterminate was defined as lost to follow-up or amputation due to vascular insufficiency (from initiation of study drug to outcome assessment visit). |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Clinical Response at Day 42 in the Clinically Evaluable (CE) Population | Day 42 | CE-D42 population included all modified intent-to-treat (mITT) participants who met specific conditions for evaluability at Day 42 (D42). | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Improvement at Day 21 in the mITT Population | Baseline to Day 21 | mITT population included all ITT participants who received any amount of 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. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Improvement at Day 21 in the CE Population | Baseline to Day 21 | CE-D21 population included all mITT (modified intent-to-treat) participants who met specific conditions for evaluability at Day 21 (D21). | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Response at Day 42 in the mITT Population | Day 42 | mITT population included all ITT participants who received any amount of 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. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Response at Day 42 in the Microbiological Modified Intent-to-Treat (Micro-mITT) Population | Day 42 | Micro-mITT population included mITT participants with a Gram-positive pathogen isolated from blood and/or bone specimen. Participants whose cultures included both a Gram-positive and a Gram-negative pathogen are included. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participant With Clinical Response at Day 180 in the mITT Population | Day 180 | mITT population included all ITT participants who received any amount of 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. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Response at Day 180 in the CE Population | Day 180 | CE-D180 population included all mITT participants who met specific conditions for evaluability at Day 180 (D180). | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Response at Day 365 in the mITT Population | Day 365 | mITT population included all ITT participants who received any amount of 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. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Clinical Response at Day 365 in the CE Population | Day 365 | CE-D365 population included all mITT participants who met specific conditions for evaluability at Day 365 (D365). | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Clinical Cure by Baseline Pathogen at Day 42 in the CE Population | Day 42 | CE-D42 population included all mITT participants who met specific conditions for evaluability at Day 42 (D42). Includes participants who had baseline pathogens. Participants who had more than one pathogen at Baseline were counted in each category. | participants | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group140
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Clinical Response at Day 42 in the Clinically Evaluable (CE) Population | Dalbavancin | Clinical Cure | 97.0 | 95% Confidence Interval 89.6 to 99.6 | percentage of participants |
| Percentage of Participants With Clinical Response at Day 42 in the Clinically Evaluable (CE) Population | Standard of Care | Clinical Cure | 87.5 | 95% Confidence Interval 47.3 to 99.7 | percentage of participants |
| Percentage of Participants With Clinical Response at Day 42 in the Clinically Evaluable (CE) Population | Dalbavancin | Clinical Failure | 0.0 | 95% Confidence Interval NA to NA | percentage of participants |
| Percentage of Participants With Clinical Response at Day 42 in the Clinically Evaluable (CE) Population | Standard of Care | Clinical Failure | 12.5 | 95% Confidence Interval NA to NA | percentage of participants |
| Percentage of Participants With Clinical Response at Day 42 in the Clinically Evaluable (CE) Population | Dalbavancin | Indeterminate | 3.0 | 95% Confidence Interval NA to NA | percentage of participants |
| Percentage of Participants With Clinical Response at Day 42 in the Clinically Evaluable (CE) Population | Standard of Care | Indeterminate | 0.0 | 95% Confidence Interval NA to NA | percentage of participants |
| Percentage of Participants With Clinical Improvement at Day 21 in the mITT Population | Dalbavancin | 94.0 | 95% Confidence Interval 85.4 to 98.3 | percentage of participants | |
| Percentage of Participants With Clinical Improvement at Day 21 in the mITT Population | Standard of Care | 62.5 | 95% Confidence Interval 24.5 to 91.5 | percentage of participants | |
| Percentage of Participants With Clinical Improvement at Day 21 in the CE Population | Dalbavancin | 94.0 | 95% Confidence Interval 85.4 to 98.3 | percentage of participants | |
| Percentage of Participants With Clinical Improvement at Day 21 in the CE Population | Standard of Care | 62.5 | 95% Confidence Interval 24.5 to 91.5 | percentage of participants |
1 to 10 of 140Source ClinicalTrials.gov
See all 140 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dalbavancin | 70 | |
| Overall Study | STARTED | Standard of Care | 10 | |
| Overall Study | COMPLETED | Dalbavancin | 67 | |
| Overall Study | COMPLETED | Standard of Care | 8 | |
| Overall Study | NOT COMPLETED | Dalbavancin | 3 | |
| Overall Study | NOT COMPLETED | Standard of Care | 2 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Cardiac failure acute | Cardiac disorders | Dalbavancin | 1 | 70 | 1 |
| serious | Cardiac failure acute | Cardiac disorders | Standard of Care | 0 | 10 | 0 |
| serious | Inflammation of wound | Injury, poisoning and procedural complications | Dalbavancin | 1 | 70 | 1 |
| serious | Inflammation of wound | Injury, poisoning and procedural complications | Standard of Care | 0 | 10 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dalbavancin | 1 | 70 |
| Total, all-cause mortality | Standard of Care | 0 | 10 |
| Total, other adverse events | Dalbavancin | 0 | 70 |
| Total, other adverse events | Standard of Care | 0 | 10 |
| Total, serious adverse events | Dalbavancin | 2 | 70 |
| Total, serious adverse events | Standard of Care | 0 | 10 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30648126 | DERIVED |
Source PubMed
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Dalbavancin vs Standard of Care: deaths from any cause | Trial comparisons |
| Dalbavancin vs Standard of Care: serious adverse events | Trial comparisons |
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.
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/NCT02685033
GET https://conductscience.org/api/trials/v1/NCT02685033/results?page=2