Comparison · NCT04775953-27dd1e08
Dalbavancin vs Standard of Care: Frequency of AEs Leading to Study Drug Discontinuation
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 AEs Leading to Study Drug Discontinuation. Trial comparisons, record NCT04775953-27dd1e08. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04775953-27dd1e08
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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 | 0.03 | 0.0103 | 0.0845 | wilson | |
| Risk in group 2 | 0.12 | 0.07 | 0.198 | wilson | |
| Risk difference, group 1 minus group 2 | -0.09 | -0.171 | -0.016 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.25 | 0.0728 | 0.859 | log | |
| Odds ratio, group 1 over group 2 | 0.227 | 0.062 | 0.83 | log | |
| Number needed to treat, for one fewer participant with the outcome on Dalbavancin than on Standard of Care | 11.1 | 5.86 | 62.4 | from the risk difference interval |
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 | 3 | 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. | 12 | 100 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Frequency of AEs Leading to Study Drug Discontinuation
- Description
- 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).
- Time frame
- Day 1 through Day 180
- Population
- The 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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