Comparison · NCT04775953-sae
Dalbavancin vs Standard of Care: serious adverse events
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: serious adverse events. Trial comparisons, record NCT04775953-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04775953-sae
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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 | 0.43 | 0.337 | 0.528 | wilson | |
| Risk in group 2 | 0.37 | 0.282 | 0.468 | wilson | |
| Risk difference, group 1 minus group 2 | 0.06 | -0.0747 | 0.192 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.16 | 0.826 | 1.63 | log | |
| Odds ratio, group 1 over group 2 | 1.28 | 0.729 | 2.26 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Dalbavancin than on Standard of Care | 16.7 | 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 | 43 | 100 | EG000 |
| 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. | 37 | 100 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
All unsolicited AEs grade 3 or higher, including laboratory abnormalities, as well as adverse events of special interest (AESIs) of any severity from time of first dose of study drug (i.e., dalbavancin or standard of care antibiotic) after randomization through follow-up (Day 70 or Day 180 for participants in osteomyelitis subset) were reported.
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.
For software
Read this comparison from software.
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GET https://conductscience.org/api/comparisons/v1/NCT04775953-sae