Trial · NCT04775953
DOTS: Dalbavancin as an Option for Treatment of Staphylococcus Aureus Bacteremia
NCT04775953, Phase 2, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2024-10-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. DOTS: Dalbavancin as an Option for Treatment of Staphylococcus Aureus Bacteremia. Trials, record NCT04775953. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04775953
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- DOTS: Dalbavancin as an Option for Treatment of Staphylococcus Aureus Bacteremia
- NCT number
- NCT04775953
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 200 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- Staphylococcal Bacteraemia
- Interventions
- Cefazolin, Dalbavancin, Daptomycin, Nafcillin, Oxacillin, Vancomycin
- First posted
- 2021-03-01
- Last updated
- 2024-12-10
- Results first posted
- 2024-10-22
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Desirability of Outcome Ranking (DOOR) | Day 70 | DOOR is a composite endpoint assessed by: (1) Clinical Failure: Lack of resolution of clinical signs and symptoms of S. aureus bacteremia such that no additional antibiotic therapy is required or anticipated for its treatment; (2) Infectious Complications such as: Endocarditis, New evidence of metastatic foci of infection, relapse - isolation of baseline S. aureus pathogen from a blood culture drawn after randomization, readmission for subsequent care of indication under study, need for additional unplanned source control procedures, or change in antibiotic therapy due to inadequate clinical response; (3) Serious Adverse Events (SAEs); (4) Adverse Events (AEs) Leading to Study Drug Discontinuation; and (5) Death. Clinical failure and infectious complications were assessed by a blinded adjudication committee. Participants missing clinical failure were treated as having clinical failure for calculation of DOOR. |
| Secondary | Frequency of Clinical Efficacy | Day 70 | Number of participants that had clinical efficacy at Day 70. Clinical efficacy is defined as none of: (1) Clinical Failure: Lack of resolution of clinical signs and symptoms of S. aureus bacteremia such that no additional antibiotic therapy is required or anticipated for its treatment; (2) Infectious Complications such as: Endocarditis, New evidence of metastatic foci of infection, relapse - isolation of baseline S. aureus pathogen from a blood culture drawn after randomization, readmission for subsequent care of indication under study, need for additional unplanned source control procedures, or change in antibiotic therapy due to inadequate clinical response; and (3) Death. Clinical failure and infectious complications are assessed by a blinded adjudication committee. Participants missing clinical failure are treated as not having clinical efficacy. |
| Secondary | Frequency of SAEs | Day 1 through Day 180 | Number of participants that experience any SAEs from Day 1 to study completion (Day 70 or Day 180 for participants in the osteomyelitis subset). An AE is considered serious if, in the view of either the site principal investigator or sponsor, it results in: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. |
| Secondary | Frequency of AEs Leading to Study Drug Discontinuation | Day 1 through Day 180 | Number of participants that experience any AEs leading to study drug discontinuation from Day 1 to study completion (Day 70 or Day 180 for participants in the osteomyelitis subset). |
| Secondary | Frequency of Clinical Failure (A Component of DOOR) | Day 70 | Number of participants who had clinical failure at Day 70, used for DOOR at Day 70. Clinical Failure is defined as lack of resolution of clinical signs and symptoms of S. aureus bacteremia such that no additional antibiotic therapy is required or anticipated for its treatment. Clinical failure is assessed by a blinded adjudication committee. Participants missing clinical failure are treated as having clinical failure. |
| Secondary | Frequency of Infectious Complications (A Component of DOOR) | Day 1 through Day 70 | Number of participants that experience any infectious complications from Day 1 through Day 70, used for DOOR at Day 70. Infectious complications include endocarditis, new evidence of metastatic foci of infection, relapse - isolation of baseline S. aureus pathogen from a blood culture drawn after randomization, readmission for subsequent care of indication under study, need for additional unplanned source control procedures, or change in antibiotic therapy due to inadequate clinical response. Infectious complications are assessed by a blinded adjudication committee. |
| Secondary | Frequency of SAEs (A Component of DOOR) | Day 1 through Day 70 | Number of participants that experience any SAEs from Day 1 to Day 70, used for DOOR at Day 70. An AE is considered serious if, in the view of either the site principal investigator or sponsor, it results in: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. |
| Secondary | Frequency of AEs Leading to Study Drug Discontinuation (A Component of DOOR) | Day 1 through Day 70 | Number of participants that experience any AEs leading to study drug discontinuation from Day 1 to Day 70, used for DOOR at Day 70. |
| Secondary | Frequency of All-Cause Mortality (A Component of DOOR) | Day 1 through Day 70 | Number of participants who passed away from Day 1 to Day 70, used for DOOR at Day 70. |
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 | Desirability of Outcome Ranking (DOOR) | Day 70 | The intent-to-treat (ITT) population includes all randomized participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Frequency of Clinical Efficacy | Day 70 | The modified intent-to-treat (mITT) population includes all randomized participants who received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Frequency of SAEs | Day 1 through Day 180 | The mITT population includes all randomized participants who received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Frequency of AEs Leading to Study Drug Discontinuation | Day 1 through Day 180 | The mITT population includes all randomized participants who received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Frequency of Clinical Failure (A Component of DOOR) | Day 70 | The ITT population includes all randomized participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Frequency of Infectious Complications (A Component of DOOR) | Day 1 through Day 70 | The ITT population includes all randomized participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Frequency of SAEs (A Component of DOOR) | Day 1 through Day 70 | The ITT population includes all randomized participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Frequency of AEs Leading to Study Drug Discontinuation (A Component of DOOR) | Day 1 through Day 70 | The ITT population includes all randomized participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Frequency of All-Cause Mortality (A Component of DOOR) | Day 1 through Day 70 | The ITT population includes all randomized participants. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Desirability of Outcome Ranking (DOOR) | Dalbavancin | Rank 1: Alive with none of clinical failure, infectious comp, or SAE or AE leading to trt discont | 49 | Participants | |
| Desirability of Outcome Ranking (DOOR) | Standard of Care | Rank 1: Alive with none of clinical failure, infectious comp, or SAE or AE leading to trt discont | 49 | Participants | |
| Desirability of Outcome Ranking (DOOR) | Dalbavancin | Rank 2: Alive with one of clinical failure, infectious comp, or SAE or AE leading to trt discont | 34 | Participants | |
| Desirability of Outcome Ranking (DOOR) | Standard of Care | Rank 2: Alive with one of clinical failure, infectious comp, or SAE or AE leading to trt discont | 37 | Participants | |
| Desirability of Outcome Ranking (DOOR) | Dalbavancin | Rank 3: Alive with two of clinical failure, infectious comp, or SAE or AE leading to trt discont | 9 | Participants | |
| Desirability of Outcome Ranking (DOOR) | Standard of Care | Rank 3: Alive with two of clinical failure, infectious comp, or SAE or AE leading to trt discont | 7 | Participants | |
| Desirability of Outcome Ranking (DOOR) | Dalbavancin | Rank 4: Alive with all of clinical failure, infectious comp, and SAE or AE leading to trt discont | 4 | Participants | |
| Desirability of Outcome Ranking (DOOR) | Standard of Care | Rank 4: Alive with all of clinical failure, infectious comp, and SAE or AE leading to trt discont | 3 | Participants | |
| Desirability of Outcome Ranking (DOOR) | Dalbavancin | Rank 5: Death | 4 | Participants | |
| Desirability of Outcome Ranking (DOOR) | Standard of Care | Rank 5: Death | 4 | Participants |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 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 | 100 | |
| Overall Study | STARTED | Standard of Care | 100 | |
| Overall Study | COMPLETED | Dalbavancin | 84 | |
| Overall Study | COMPLETED | Standard of Care | 81 | |
| Overall Study | NOT COMPLETED | Dalbavancin | 16 | |
| Overall Study | NOT COMPLETED | Standard of Care | 19 |
Source ClinicalTrials.gov
Adverse events190
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 | Aspartate aminotransferase increased | Investigations | Dalbavancin | 5 | 100 | 5 |
| other | Aspartate aminotransferase increased | Investigations | Standard of Care | 1 | 100 | 1 |
| serious | Leukopenia | Blood and lymphatic system disorders | Dalbavancin | 0 | 100 | 0 |
| serious | Leukopenia | Blood and lymphatic system disorders | Standard of Care | 1 | 100 | 1 |
| serious | Anaemia | Blood and lymphatic system disorders | Dalbavancin | 1 | 100 | 1 |
| serious | Anaemia | Blood and lymphatic system disorders | Standard of Care | 1 | 100 | 1 |
| serious | Cytopenia | Blood and lymphatic system disorders | Dalbavancin | 1 | 100 | 1 |
| serious | Cytopenia | Blood and lymphatic system disorders | Standard of Care | 0 | 100 | 0 |
| serious | Febrile neutropenia | Blood and lymphatic system disorders | Dalbavancin | 1 | 100 | 1 |
| serious | Febrile neutropenia | Blood and lymphatic system disorders | Standard of Care | 0 | 100 | 0 |
1 to 10 of 190Source ClinicalTrials.gov
See all 190 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dalbavancin | 5 | 100 |
| Total, all-cause mortality | Standard of Care | 4 | 100 |
| Total, other adverse events | Dalbavancin | 5 | 100 |
| Total, other adverse events | Standard of Care | 1 | 100 |
| Total, serious adverse events | Dalbavancin | 43 | 100 |
| Total, serious adverse events | Standard of Care | 37 | 100 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UM1AI104681 | Antibacterial Resistance Leadership Group (ARLG) | FOWLER, VANCE G.; HENRY CHAMBERS, HENRY F | DUKE UNIVERSITY | NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES | 2013 to 2025 |
Source NIH RePORTER
Trial comparisons10
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Dalbavancin vs Standard of Care: Frequency of All-Cause Mortality (A Component of DOOR) | Trial comparisons |
| Dalbavancin vs Standard of Care: Frequency of AEs Leading to Study Drug Discontinuation | Trial comparisons |
| Dalbavancin vs Standard of Care: Frequency of Clinical Efficacy | Trial comparisons |
| Dalbavancin vs Standard of Care: Frequency of SAEs (A Component of DOOR) | Trial comparisons |
| Dalbavancin vs Standard of Care: Frequency of AEs Leading to Study Drug Discontinuation (A Component of DOOR) | Trial comparisons |
| Dalbavancin vs Standard of Care: Frequency of Infectious Complications (A Component of DOOR) | Trial comparisons |
| Dalbavancin vs Standard of Care: deaths from any cause | Trial comparisons |
| Dalbavancin vs Standard of Care: Frequency of Clinical Failure (A Component of DOOR) | Trial comparisons |
| Dalbavancin vs Standard of Care: Frequency of SAEs | 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/NCT04775953
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