A Study of Ceftobiprole Compared With Standard Antibiotic Treatment in Children With Staphylococcus Aureus Bacteremia (SAB) Infection, Including Right-sided Heart Infection
NCT07929493, Phase 3, Not yet recruiting, ISTx, LLC
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | A Study of Ceftobiprole Compared With Standard Antibiotic Treatment in Children With Staphylococcus Aureus Bacteremia (SAB) Infection, Including Right-sided Heart Infection | ClinicalTrials.gov |
| NCT number | NCT07929493 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 3 | ClinicalTrials.gov |
| Enrollment | 60 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | ISTx, LLC | ClinicalTrials.gov |
| Conditions | Staphylococcus Aureus Bacteremia, Endocarditis, Bacterial | ClinicalTrials.gov |
| Interventions | Ceftobiprole medocaril sodium, Standard of Care (SOC) | ClinicalTrials.gov |
| First posted | 2026-11-10 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Percentage of Participants with Treatment-Emergent Adverse Events (TEAEs) | Day 1 through last follow-up (LFU) [up to 11 weeks] | ClinicalTrials.gov | |
| Primary | Percentage of participants with serious adverse events (SAEs) | Baseline through LFU [up to 11 weeks] | ClinicalTrials.gov | |
| Primary | Percentage of participants with treatment-related adverse events (AEs) | Day 1 through LFU [up to 11 weeks] | ClinicalTrials.gov | |
| Primary | Percentage of participants with adverse events of special interest (AESIs) | Baseline through LFU [up to 11 weeks] | ClinicalTrials.gov | |
| Primary | Percentage of participants with adverse events (AEs) leading to discontinuation of study-drug treatment | Baseline through LFU [up to 11 weeks] | ClinicalTrials.gov | |
| Primary | Percentage of participants with treatment-emergent abnormal hematology laboratory test results | Baseline through the end-of-treatment (EOT) visit [up to approximately 6 weeks] | ClinicalTrials.gov | |
| Primary | Percentage of participants with treatment-emergent abnormal blood chemistry laboratory test results | Baseline through the EOT visit [up to approximately 6 weeks] | ClinicalTrials.gov | |
| Primary | Percentage of participants with treatment-emergent abnormal urinalysis test results | Baseline through the EOT visit [up to approximately 6 weeks] | ClinicalTrials.gov | |
| Primary | Change from baseline in body temperature | Baseline through LFU visit [up to 11 weeks] | ClinicalTrials.gov | |
| Primary | Change from baseline in systolic blood pressure | Baseline through LFU visit [up to 11 weeks] | ClinicalTrials.gov | |
| Primary | Change from baseline in diastolic blood pressure | Baseline through LFU visit [up to 11 weeks] | ClinicalTrials.gov | |
| Primary | Change from baseline in respiratory rate | Baseline through LFU visit [up to 11 weeks] | ClinicalTrials.gov | |
| Primary | Change from baseline in heart rate | Baseline through LFU visit [up to 11 weeks] | ClinicalTrials.gov | |
| Secondary | Percentage of All-Cause Mortality (ACM) | Through 28 days after EOT [up to approximately 10 weeks] | Defined as death from any cause including death due to SAB | ClinicalTrials.gov |
| Secondary | Percentage of new metastatic foci or other complications of SAB | Day 8 through test-of-cure (TOC) [up to approximately 8 Weeks] | Complications are considered new between Day 8 and TOC | ClinicalTrials.gov |
| Secondary | Percentage of participants with Clinical Success at the TOC Visit | TOC visit [7-14 days after EOT] | Success is defined as either cure or improvement | ClinicalTrials.gov |
| Secondary | Percentage of participants with Microbiological Success at the TOC Visit | TOC visit (7-14 days after EOT) | Microbiological success is defined as eradication or presumed eradication. | ClinicalTrials.gov |
| Secondary | Percentage of participants with Overall Success at the TOC Visit | TOC visit (7-14 days after EOT) | Overall success is defined as the achievement of both clinical success and microbiological success | ClinicalTrials.gov |
| Secondary | Ceftobiprole Plasma Concentration | Day 3 | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
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 | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
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 | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)