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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-004614-18 | EudraCT Number |
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on July 07, 2020 due to slow enrollment; there were no safety concerns.
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This study characterized the pharmacokinetics and safety of a single dose of ceftobiprole in neonates and infants aged ≤ 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ceftobiprole | Experimental | Ceftobiprole medocaril is the water-soluble prodrug of ceftobiprole, an advanced-generation cephalosporin developed for intravenous administration. Ceftobiprole is characterized by potent, broad-spectrum antimicrobial activity against both Gram-positive and Gram-negative pathogens. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ceftobiprole medocaril | Drug | Ceftobiprole medocaril was administered as a single intravenous infusion, with a bodyweight-adjusted volume, at a constant rate over 4 hours. The ceftobiprole dose was 7.5 mg/kg, which corresponds to 10.0 mg ceftobiprole medocaril. |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | The maximum observed plasma concentration (Cmax) | Blood samples for pharmacokinetic (PK) analysis were obtained pre-dose, and at 2, 4, 6, 8, and 12 hours after the start of dosing. |
| Tmax | The time of maximum observed plasma concentration (Tmax) | Blood samples for PK analysis were obtained pre-dose, and at 2, 4, 6, 8, and 12 hours after the start of dosing. |
| AUC0-last | The area under the plasma concentration-time curve from time zero to the time of the last measurable concentration (AUC0-last) | Blood samples for PK analysis were obtained pre-dose, and at 2, 4, 6, 8, and 12 hours after the start of dosing. |
| T>MIC of 4 mg/L | The duration of time after dose for which free-drug concentrations remained above a value of 4 mg/L (T>MIC of 4 mg/L) | Blood samples for PK analysis were obtained pre-dose, and at 2, 4, 6, 8, and 12 hours after the start of dosing. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc Engelhardt, MD | Basilea Pharmaceutica | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University Medical Center | Loma Linda | California | 92354 | United States | ||
| University of Southern California |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34533489 | Derived | Rubino CM, Polak M, Schropf S, Munch HG, Smits A, Cossey V, Tomasik T, Kwinta P, Snariene R, Liubsys A, Gardovska D, Hornik CD, Bosheva M, Ruehle C, Litherland K, Hamed K. Pharmacokinetics and Safety of Ceftobiprole in Pediatric Patients. Pediatr Infect Dis J. 2021 Nov 1;40(11):997-1003. doi: 10.1097/INF.0000000000003296. |
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Subjects with documented or presumed bacterial infection receiving standard-of-care antibiotic treatment were screened.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ceftobiprole ITT/Safety Population | All subjects who received any quantity of study drug. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 21, 2019 | Dec 4, 2020 |
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| Los Angeles |
| California |
| 90089 |
| United States |
| University of California Los Angeles | Los Angeles | California | 90095 | United States |
| Beacon Children's Hospital | South Bend | Indiana | 46601 | United States |
| Norton Children's Hospital | Louisville | Kentucky | 40202 | United States |
| Duke University Hospital | Durham | North Carolina | 27705 | United States |
| University of Pittsburgh Medical Center Cancer Center at Magee-Womens Hospital | Pittsburgh | Pennsylvania | 15224 | United States |
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| West Virginia University School of Medicine | Morgantown | West Virginia | 26506-9214 | United States |
| UZ Leuven | Leuven | Belgium |
| Klinikum der Universität München | Munich | Germany |
| Children Clinical University Hospital | Riga | Latvia |
| Vilnius University Children's Hospital | Vilnius | Lithuania |
| University Children's Hospital of Kraków | Krakow | Poland |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Ceftobiprole ITT/Safety Population | All subjects who received any quantity of study drug. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants | No |
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| Age, Continuous | Median | Inter-Quartile Range | days |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cmax | The maximum observed plasma concentration (Cmax) | Posted | Median | Full Range | μg/mL | Blood samples for pharmacokinetic (PK) analysis were obtained pre-dose, and at 2, 4, 6, 8, and 12 hours after the start of dosing. |
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| Primary | Tmax | The time of maximum observed plasma concentration (Tmax) | Posted | Median | Full Range | hours | Blood samples for PK analysis were obtained pre-dose, and at 2, 4, 6, 8, and 12 hours after the start of dosing. |
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| Primary | AUC0-last | The area under the plasma concentration-time curve from time zero to the time of the last measurable concentration (AUC0-last) | Posted | Median | Full Range | μg•hours/mL | Blood samples for PK analysis were obtained pre-dose, and at 2, 4, 6, 8, and 12 hours after the start of dosing. |
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| Primary | T>MIC of 4 mg/L | The duration of time after dose for which free-drug concentrations remained above a value of 4 mg/L (T>MIC of 4 mg/L) | Posted | Median | Full Range | hours | Blood samples for PK analysis were obtained pre-dose, and at 2, 4, 6, 8, and 12 hours after the start of dosing. |
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After start of study drug administration through the follow-up visit at study Day 7±3, relevant worsening of a subject's status was to be recorded as an adverse event (AE).
Once an AE was detected, it was proactively followed up at each visit (or more frequently if necessary) for any changes in severity, relationship to the study drug, interventions required for treatment, and the event's outcome. Serious adverse events (SAEs) were to be additionally reported and recorded on SAE report forms.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ceftobiprole ITT/Safety Population | All subjects who received any quantity of study drug. | 0 | 15 | 2 | 15 | 4 | 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diaphragmatic hernia | Gastrointestinal disorders | MeDRA 20.1 | Systematic Assessment |
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| Cerebral infarction | Nervous system disorders | MeDRA 20.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drug Dependence | Psychiatric disorders | MeDRA 20.1 | Systematic Assessment |
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| Dermatitis diaper | Skin and subcutaneous tissue disorders | MeDRA 20.1 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MeDRA 20.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Project Physician | Basilea Pharmaceutica International Ltd. | +41 79 701 0551 | marc.engelhardt@basilea.com |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 17, 2020 | Dec 4, 2020 | SAP_000.pdf |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C505439 | ceftobiprole medocaril |
| C443755 | ceftobiprole |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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