Trial · NCT03148756
Efficacy and Safety of Dalbavancin Compared to Standard of Care Antibiotic Therapy for the Completion of Treatment of Patients With Complicated Bacteremia or Infective Endocarditis
NCT03148756, Phase 2, Terminated, AbbVie; results first posted 2018-09-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Dalbavancin Compared to Standard of Care Antibiotic Therapy for the Completion of Treatment of Patients With Complicated Bacteremia or Infective Endocarditis. Trials, record NCT03148756. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03148756
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Dalbavancin Compared to Standard of Care Antibiotic Therapy for the Completion of Treatment of Patients With Complicated Bacteremia or Infective Endocarditis
- NCT number
- NCT03148756
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 2 participants, actual
- Lead sponsor
- AbbVie
- Conditions
- Endocarditis, Bacteremia
- Interventions
- Dalbavancin, Standard of Care
- First posted
- 2017-05-11
- Last updated
- 2022-04-25
- Results first posted
- 2018-09-10
Source ClinicalTrials.gov
Registered outcomes13
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 84 in the Intent-to Treat (ITT) Population | Day 84 | Clinical response was either success or failure. Success was defined as resolution of clinical signs and symptoms of complicated bacteremia or infective endocarditis (IE) such that no additional antibiotic therapy was required. Failure was defined as: ongoing signs and symptoms considered by the investigator to be related to complicated bacteremia or IE requiring additional antibacterial therapy or unplanned valve replacement, recurrent bacteremia, death during the study period up to Day 84 or discontinuation of the study medication due to an adverse event. |
| Secondary | Percentage of Participants With Clinical Outcome of Success at Day 42 in the ITT Population | Day 42 | Clinical outcome was either success or failure. Success was defined as resolution of clinical signs and symptoms of complicated bacteremia or infective endocarditis (IE) such that no additional antibiotic therapy was required. |
| Secondary | Percentage of Participants With Clinical Outcome of Success at Day 42 in the Clinically Evaluable (CE) Population | Day 42 | Clinical outcome was either success or failure. Success was defined as resolution of clinical signs and symptoms of complicated bacteremia or infective endocarditis (IE) such that no additional antibiotic therapy was required. |
| Secondary | Number of Participants With Day 84 Mortality in the Safety Population | Day 84 | Day 84 mortality was measured by the number of deaths up to Day 84. |
| Secondary | Percentage of Participants With Clinical Outcome of Success at Day 84 in the CE Population | Day 84 | Clinical outcome was either success or failure/relapse. Success was defined as resolution of clinical signs and symptoms of complicated bacteremia or infective endocarditis (IE) such that no additional antibiotic therapy was required. |
| Secondary | Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 42 in the ITT Population | Day 42 | Clinical outcome was either success or failure. Success was defined as resolution of clinical signs and symptoms of complicated bacteremia or infective endocarditis (IE) such that no additional antibiotic therapy was required. |
| Secondary | Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 84 in the ITT Population | Day 84 | Clinical outcome was either success or failure. Success was defined as resolution of clinical signs and symptoms of complicated bacteremia or infective endocarditis (IE) such that no additional antibiotic therapy was required. |
| Secondary | Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 42 in the CE Population | Day 42 | Clinical outcome was either success or failure. Success was defined as resolution of clinical signs and symptoms of complicated bacteremia or infective endocarditis (IE) such that no additional antibiotic therapy was required. |
| Secondary | Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 84 in the CE Population | Day 84 | Clinical outcome was either success or failure. Success was defined as resolution of clinical signs and symptoms of complicated bacteremia or infective endocarditis (IE) such that no additional antibiotic therapy was required. |
| Secondary | Percentage of Participants With Microbiological Success by Pathogen at Day 42 in the ITT Population | Day 42 | Microbiological outcome could be either microbiologic success or microbiologic failure. Microbiologic Success was defined as no further growth of baseline pathogen from blood cultures. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
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 84 in the Intent-to Treat (ITT) Population | Day 84 | ITT Population included all randomized participants regardless of whether or not study treatment was received. No participants were enrolled in the Dalbavancin arm. Due to early termination of the study, 1 participant did not have clinical outcomes determined, but did have an early termination visit. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Clinical Outcome of Success at Day 42 in the ITT Population | Day 42 | ITT Population included all randomized participants regardless of whether or not study treatment was received. No participants were enrolled in the Dalbavancin arm. Due to early termination of the study, 1 participant did not have clinical outcomes determined, but did have an early termination visit. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Outcome of Success at Day 42 in the Clinically Evaluable (CE) Population | Day 42 | CE Population included all participants in the mITT Population (all in the ITT who received ≥1 dose of study treatment) who met criteria for clinical evaluability. No participants were enrolled in the Dalbavancin arm. Due to early termination of the study, 1 participant did not have clinical outcomes determined, but did have a termination visit. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Day 84 Mortality in the Safety Population | Day 84 | Safety Population included all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in the Dalbavancin arm. Due to early termination of the study, 1 participant did not have clinical outcomes determined, but did have an early termination visit. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Clinical Outcome of Success at Day 84 in the CE Population | Day 84 | CE Population included all participants in the mITT Population (all in the ITT who received ≥1 dose of study treatment) who met criteria for clinical evaluability. No participants were enrolled in the Dalbavancin arm. Due to early termination of the study, 1 participant did not have clinical outcomes determined, but did have a termination visit. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 42 in the ITT Population | Day 42 | ITT Population included all randomized participants regardless of whether or not study treatment was received. No participants were enrolled in the Dalbavancin arm. Due to early termination of the study, 1 participant did not have clinical outcomes determined, but did have an early termination visit. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 84 in the ITT Population | Day 84 | ITT Population included all randomized participants regardless of whether or not study treatment was received. No participants were enrolled in the Dalbavancin arm. Due to early termination of the study, 1 participant did not have clinical outcomes determined, but did have an early termination visit. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 42 in the CE Population | Day 42 | CE Population included all participants in the mITT Population (all in the ITT who received ≥1 dose of study treatment) who met criteria for clinical evaluability. No participants were enrolled in the Dalbavancin arm. Due to early termination of the study, 1 participant did not have clinical outcomes determined, but did have a termination visit. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 84 in the CE Population | Day 84 | CE Population included all participants in the mITT Population (all in the ITT who received ≥1 dose of study treatment) who met criteria for clinical evaluability. No participants were enrolled in the Dalbavancin arm. Due to early termination of the study, 1 participant did not have clinical outcomes determined, but did have a termination visit. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Microbiological Success by Pathogen at Day 42 in the ITT Population | Day 42 | ITT Population included all randomized participants regardless of whether or not study treatment was received. No participants were enrolled in the Dalbavancin arm. Due to early termination of the study, 1 participant did not have clinical outcomes determined, but did have an early termination visit. | percentage of participants | NUMBER |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Clinical Response at Day 84 in the Intent-to Treat (ITT) Population | Standard of Care | Success | 1 | Participants | |
| Number of Participants With Clinical Response at Day 84 in the Intent-to Treat (ITT) Population | Standard of Care | Failure | 0 | Participants | |
| Percentage of Participants With Clinical Outcome of Success at Day 42 in the ITT Population | Standard of Care | 100 | percentage of participants | ||
| Percentage of Participants With Clinical Outcome of Success at Day 42 in the Clinically Evaluable (CE) Population | Standard of Care | 100 | percentage of participants | ||
| Number of Participants With Day 84 Mortality in the Safety Population | Standard of Care | 0 | Participants | ||
| Percentage of Participants With Clinical Outcome of Success at Day 84 in the CE Population | Standard of Care | 100 | percentage of participants | ||
| Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 42 in the ITT Population | Standard of Care | 100 | percentage of participants | ||
| Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 84 in the ITT Population | Standard of Care | 100 | percentage of participants | ||
| Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 42 in the CE Population | Standard of Care | 100 | percentage of participants | ||
| Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 84 in the CE Population | Standard of Care | 100 | percentage of participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 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 | 0 | |
| Overall Study | STARTED | Standard of Care | 2 | |
| Overall Study | COMPLETED | Dalbavancin | 0 | |
| Overall Study | COMPLETED | Standard of Care | 1 | |
| Overall Study | NOT COMPLETED | Dalbavancin | 0 | |
| Overall Study | NOT COMPLETED | Standard of Care | 1 |
Source ClinicalTrials.gov
Adverse events2
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 |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Dalbavancin | 0 | 0 | |
| other | Anaemia | Blood and lymphatic system disorders | Standard of Care | 1 | 2 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dalbavancin | 0 | 0 |
| Total, all-cause mortality | Standard of Care | 0 | 2 |
| Total, other adverse events | Dalbavancin | 0 | 0 |
| Total, other adverse events | Standard of Care | 1 | 2 |
| Total, serious adverse events | Dalbavancin | 0 | 0 |
| Total, serious adverse events | Standard of Care | 0 | 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.
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/NCT03148756
GET https://conductscience.org/api/trials/v1/NCT03148756/registered