A Phase 3 interventional study of Ceftobiprole medocaril sodium and Standard of Care (SOC) in Staphylococcus Aureus Bacteremia and Endocarditis, Bacterial, sponsored by ISTx, LLC. Not yet recruiting. Open to participants aged 3 Days to 17 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by ISTx, LLC · Phase 3, Interventional, and Treatment
This clinical trial will evaluate the safety, and effectiveness of ceftobiprole compared to standard-of-care antibiotic treatment in children from birth to less than 18 years of age with Staphylococcus aureus bloodstream infection, including right-sided infective endocarditis (IE). The trial will also evaluate the pharmacokinetics of ceftobiprole.
22 studies on the registry are indexed under Endocarditis, Bacterial; 9 are open to participants now.
This study's planned enrollment of 60 is above the median of 38 across 11 interventional studies indexed under Endocarditis, Bacterial.
Browse Endocarditis, Bacterial studies →This is the only study on the registry with ISTx, LLC as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
SAB:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants randomized to this arm will receive intravenous (IV) ceftobiprole.
Drug: Ceftobiprole medocaril sodium
Participants randomized to this arm will receive intravenous (IV) standard-of-care (SOC) antibiotic treatment selected according to local guidelines or site-specific standard practice.
Drug: Standard of Care (SOC)
Ceftobiprole dosing is based on age/body weight and renal function and given at 7.5 mg/kg, 10 mg/kg, or 15 mg/kg (equivalent to 10 mg/kg, 13.3 mg/kg, or 20 mg/kg respectively of ceftobiprole medocaril sodium) q8h, q12h or q24h up to a maximum of 500 mg (equivalent to 667 mg of ceftobiprole medocaril sodium), with all doses infused over 2 hours.
Dosage is per local product label based on the participant's age/body weight, and, if applicable, renal function.
Percentage of Participants with Treatment-Emergent Adverse Events (TEAEs)
Time frame: Day 1 through last follow-up (LFU) [up to 11 weeks]
Percentage of participants with serious adverse events (SAEs)
Time frame: Baseline through LFU [up to 11 weeks]
Percentage of participants with treatment-related adverse events (AEs)
Time frame: Day 1 through LFU [up to 11 weeks]
Percentage of participants with adverse events of special interest (AESIs)
Time frame: Baseline through LFU [up to 11 weeks]
Percentage of participants with adverse events (AEs) leading to discontinuation of study-drug treatment
Time frame: Baseline through LFU [up to 11 weeks]
Percentage of participants with treatment-emergent abnormal hematology laboratory test results
Time frame: Baseline through the end-of-treatment (EOT) visit [up to approximately 6 weeks]
Percentage of participants with treatment-emergent abnormal blood chemistry laboratory test results
Time frame: Baseline through the EOT visit [up to approximately 6 weeks]
Percentage of participants with treatment-emergent abnormal urinalysis test results
Time frame: Baseline through the EOT visit [up to approximately 6 weeks]
Change from baseline in body temperature
Time frame: Baseline through LFU visit [up to 11 weeks]
Change from baseline in systolic blood pressure
Time frame: Baseline through LFU visit [up to 11 weeks]
Change from baseline in diastolic blood pressure
Time frame: Baseline through LFU visit [up to 11 weeks]
Change from baseline in respiratory rate
Time frame: Baseline through LFU visit [up to 11 weeks]
Change from baseline in heart rate
Time frame: Baseline through LFU visit [up to 11 weeks]
Percentage of All-Cause Mortality (ACM)
Defined as death from any cause including death due to SAB
Time frame: Through 28 days after EOT [up to approximately 10 weeks]
Percentage of new metastatic foci or other complications of SAB
Complications are considered new between Day 8 and TOC
Time frame: Day 8 through test-of-cure (TOC) [up to approximately 8 Weeks]
Percentage of participants with Clinical Success at the TOC Visit
Success is defined as either cure or improvement
Time frame: TOC visit [7-14 days after EOT]
Percentage of participants with Microbiological Success at the TOC Visit
Microbiological success is defined as eradication or presumed eradication.
Time frame: TOC visit (7-14 days after EOT)
Percentage of participants with Overall Success at the TOC Visit
Overall success is defined as the achievement of both clinical success and microbiological success
Time frame: TOC visit (7-14 days after EOT)
Ceftobiprole Plasma Concentration
Time frame: Day 3
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.