Trial · NCT03138733
Ceftobiprole in the Treatment of Patients With Staphylococcus Aureus Bacteremia
NCT03138733, Phase 3, Completed, Basilea Pharmaceutica; results first posted 2023-05-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Ceftobiprole in the Treatment of Patients With Staphylococcus Aureus Bacteremia. Trials, record NCT03138733. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03138733
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ceftobiprole in the Treatment of Patients With Staphylococcus Aureus Bacteremia
- NCT number
- NCT03138733
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 390 participants, actual
- Lead sponsor
- Basilea Pharmaceutica
- Conditions
- Staphylococcus Aureus Bacteremia
- Interventions
- Ceftobiprole medocaril, Daptomycin
- First posted
- 2017-05-03
- Last updated
- 2026-10-07
- Results first posted
- 2023-05-06
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With or Without Overall Success at the Post-treatment Evaluation (PTE) Visit | PTE visit on Day 70 (± 5 days) post-randomization | Comparison of overall success rates in the mITT population Overall success at PTE for the mITT population was defined as all of the following criteria being met (Responder): 1. Patient alive at Day 70 (± 5 days) post-randomization. 2. No new metastatic foci or complications of the SAB infection. 3. Resolution or improvement of SAB-related clinical signs and symptoms. 4. Two negative blood cultures for S. aureus (without any subsequent positive blood culture for S. aureus) |
| Secondary | Number of Patients With or Without Overall Success at the PTE Visit in the CE Population | At PTE visit on Day 70 (± 5 days) post-randomization | Comparison of overall success rates in the Clinical Evaluable (CE) population Overall success at PTE for the CE population was defined as all of the following criteria being met (Responder): 1. Patient alive at Day 70 (± 5 days) post-randomization. 2. No new metastatic foci or complications of the SAB infection. 3. Resolution or improvement of SAB-related clinical signs and symptoms. 4. Two negative blood cultures for S. aureus (without any subsequent positive blood culture for S. aureus) |
| Secondary | Number of Patients With Microbiological Eradication at the PTE Visit | At PTE visit on Day 70 (± 5 days) post-randomization | Comparison of microbiological eradication rates in the mITT population. Microbiological eradication rate was defined as a negative blood culture for S. aureus during study treatment and another negative blood culture during the follow up period up to PTE. |
| Secondary | All-cause Mortality at the PTE Visit | At PTE visit on Day 70 (± 5 days) post-randomization | Comparison of all-cause mortality rates in the mITT population |
| Secondary | Number of Patients With or Without New Metastatic Foci or Other Complications of SAB Developed After Day 7 | Assessment after Day 7 post-randomization through to post-treatment evaluation (PTE) visit on Day 70 (± 5 days) | Comparison of complication rates in the mITT population defined by number of patients with development of new metastatic foci or other complications of SAB after Day 7 |
| Secondary | Time to Staphylococcus Aureus Bloodstream Clearance | Up to 6 weeks post-randomization | Time-to-event in the mITT Bloodstream clearance was defined as two consecutive study days with blood-culture-negative assessments for S. aureus, without any subsequent S. aureus relapse or reinfection |
| Secondary | Number of Patients With or Without Adverse Events (AEs) | AEs were assessed from the first dose of study drug through the post-treatment evaluation (PTE) visit on Day 70 (± 5 days) | Treatment-emergent adverse events in the safety population |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients With or Without Overall Success at the Post-treatment Evaluation (PTE) Visit | PTE visit on Day 70 (± 5 days) post-randomization | The mITT population comprised the subset of patients in the ITT population who received any dose of study medication, and had a blood culture positive for S. aureus at baseline | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients With or Without Overall Success at the PTE Visit in the CE Population | At PTE visit on Day 70 (± 5 days) post-randomization | The CE population comprised the subset of patients in the mITT population who complied with important pre-specified aspects of the study | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients With Microbiological Eradication at the PTE Visit | At PTE visit on Day 70 (± 5 days) post-randomization | The mITT population comprised the subset of patients in the ITT population who received any dose of study medication, and had a blood culture positive for S. aureus at baseline | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | All-cause Mortality at the PTE Visit | At PTE visit on Day 70 (± 5 days) post-randomization | The mITT population comprised the subset of patients in the ITT population who received any dose of study medication, and had a blood culture positive for S. aureus at baseline | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients With or Without New Metastatic Foci or Other Complications of SAB Developed After Day 7 | Assessment after Day 7 post-randomization through to post-treatment evaluation (PTE) visit on Day 70 (± 5 days) | The mITT population comprised the subset of patients in the ITT population who received any dose of study medication, and had a blood culture positive for S. aureus at baseline | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Staphylococcus Aureus Bloodstream Clearance | Up to 6 weeks post-randomization | The mITT population comprised the subset of patients in the ITT population who received any dose of study medication, and had a blood culture positive for S. aureus at baseline | Days | MEDIAN |
| SECONDARY | Number of Patients With or Without Adverse Events (AEs) | AEs were assessed from the first dose of study drug through the post-treatment evaluation (PTE) visit on Day 70 (± 5 days) | The Safety population comprised all randomized patients who received any dose of study drug. Patients in the Safety population were analyzed according to the first study drug received. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group44
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With or Without Overall Success at the Post-treatment Evaluation (PTE) Visit | Ceftobiprole | Number of responders | 132 | Participants | |
| Number of Patients With or Without Overall Success at the Post-treatment Evaluation (PTE) Visit | Daptomycin | Number of responders | 136 | Participants | |
| Number of Patients With or Without Overall Success at the Post-treatment Evaluation (PTE) Visit | Ceftobiprole | Number of non-responders | 57 | Participants | |
| Number of Patients With or Without Overall Success at the Post-treatment Evaluation (PTE) Visit | Daptomycin | Number of non-responders | 62 | Participants | |
| Number of Patients With or Without Overall Success at the PTE Visit in the CE Population | Ceftobiprole | Number of responders | 127 | Participants | |
| Number of Patients With or Without Overall Success at the PTE Visit in the CE Population | Daptomycin | Number of responders | 130 | Participants | |
| Number of Patients With or Without Overall Success at the PTE Visit in the CE Population | Ceftobiprole | Number of non-responders | 36 | Participants | |
| Number of Patients With or Without Overall Success at the PTE Visit in the CE Population | Daptomycin | Number of non-responders | 37 | Participants | |
| Number of Patients With Microbiological Eradication at the PTE Visit | Ceftobiprole | 155 | Participants | ||
| Number of Patients With Microbiological Eradication at the PTE Visit | Daptomycin | 153 | Participants |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ceftobiprole | 192 | |
| Overall Study | STARTED | Daptomycin | 198 | |
| Overall Study | Modified ITT (mITT) | Ceftobiprole | 189 | |
| Overall Study | Modified ITT (mITT) | Daptomycin | 198 | |
| Overall Study | COMPLETED | Ceftobiprole | 157 | |
| Overall Study | COMPLETED | Daptomycin | 169 | |
| Overall Study | NOT COMPLETED | Ceftobiprole | 35 | |
| Overall Study | NOT COMPLETED | Daptomycin | 29 |
Source ClinicalTrials.gov
Adverse events196
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 | Blood potassium decreased | Investigations | Ceftobiprole | 17 | 191 | |
| other | Blood potassium decreased | Investigations | Daptomycin | 5 | 198 | |
| other | Gamma-glutamyltransferase increased | Investigations | Ceftobiprole | 12 | 191 | |
| other | Gamma-glutamyltransferase increased | Investigations | Daptomycin | 15 | 198 | |
| other | Anaemia | Blood and lymphatic system disorders | Ceftobiprole | 20 | 191 | |
| other | Anaemia | Blood and lymphatic system disorders | Daptomycin | 24 | 198 | |
| other | Diarrhoea | Gastrointestinal disorders | Ceftobiprole | 13 | 191 | |
| other | Diarrhoea | Gastrointestinal disorders | Daptomycin | 5 | 198 | |
| other | Nausea | Gastrointestinal disorders | Ceftobiprole | 20 | 191 | |
| other | Nausea | Gastrointestinal disorders | Daptomycin | 8 | 198 |
1 to 10 of 196Source ClinicalTrials.gov
See all 196 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ceftobiprole | 17 | 191 |
| Total, all-cause mortality | Daptomycin | 18 | 198 |
| Total, other adverse events | Ceftobiprole | 61 | 191 |
| Total, other adverse events | Daptomycin | 45 | 198 |
| Total, serious adverse events | Ceftobiprole | 36 | 191 |
| Total, serious adverse events | Daptomycin | 45 | 198 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ceftobiprole vs Daptomycin: Number of Patients With Microbiological Eradication at the PTE Visit | Trial comparisons |
| Ceftobiprole vs Daptomycin: deaths from any cause | Trial comparisons |
| Ceftobiprole vs Daptomycin: 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/NCT03138733
GET https://conductscience.org/api/trials/v1/NCT03138733/results?page=2