Comparison · NCT04775953-50ace448
Dalbavancin vs Standard of Care: Frequency of Clinical Efficacy
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Dalbavancin vs Standard of Care: Frequency of Clinical Efficacy. Trial comparisons, record NCT04775953-50ace448. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04775953-50ace448
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.73 | 0.636 | 0.807 | wilson | |
| Risk in group 2 | 0.72 | 0.625 | 0.799 | wilson | |
| Risk difference, group 1 minus group 2 | 0.01 | -0.113 | 0.132 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.01 | 0.855 | 1.2 | log | |
| Odds ratio, group 1 over group 2 | 1.05 | 0.565 | 1.96 | log | |
| Number needed to treat, for one more participant with the outcome on Dalbavancin than on Standard of Care | 100 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: standard of care.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Dalbavancin | Dalbavancin 1500 mg administrated intravenously (IV) over 30 (-/+10) minutes on Day 1 and 1500 mg IV over 30 (-/+10) minutes on Day 8, renally dose-adjusted to 1125 mg for participants with Creatinine Clearance (CrCl) \<30 and not on dialysis.~Dalbavancin: A second-generation lipoglycopeptide antibiotic synthesized from a fermentation product of Nonomuraea species | 73 | 100 | OG000 |
| Group 2 | Standard of Care | For Methicillin-sensitive Staphylococcus aureus (MSSA): nafcillin (2 g administrated intravenously (IV) every 4 hours for 4-6 weeks) OR oxacillin (2 g administrated IV every 4 hours for 4-6 weeks OR cefazolin (2 g administrated IV every 8 hours for 4-6 weeks).~For Methicillin-resistant Staphylococcus aureus (MRSA): vancomycin (dose per local standard of care × 4-6 weeks) OR daptomycin (6-10 mg/kg administrated IV daily for 4-6 weeks).~Cefazolin: Cefazolin is a semisynthetic cephalosporin analog with broad-spectrum antibiotic action due to inhibition of bacterial cell wall synthesis.~Daptomycin: Daptomycin (USA) or Cubicin (Spain) is a cyclic lipopeptide antibiotic that inhibits gram-positive bacteria.~Nafcillin: Nafcillin is a semi-synthetic antibiotic related to penicillin.~Oxacillin: Oxacillin is an antibiotic used in resistant staphylococci infections.~Vancomycin: Vancomycin is a glycopeptide antibiotic product of the organism Amycolatopsis orientalis. | 72 | 100 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Frequency of Clinical Efficacy
- Description
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.
- Time frame
- Day 70
- Population
- The modified intent-to-treat (mITT) population includes all randomized participants who received at least one dose of study drug.
Source ClinicalTrials.gov
Trial
- Title
- DOTS: Dalbavancin as an Option for Treatment of Staphylococcus Aureus Bacteremia
- NCT number
- NCT04775953
- Phases
- PHASE2
- Conditions
- Staphylococcal Bacteraemia
- Interventions
- Cefazolin, Dalbavancin, Daptomycin, Nafcillin, Oxacillin, Vancomycin
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Results first posted
- 2024-10-22
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04775953?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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