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The purpose of this study is to determine the pharmacokinetics of ceftaroline in pediatric subjects
The purpose of this study is to determine the pharmacokinetics profile of ceftaroline in pediatric subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | ceftaroline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ceftaroline | Drug | Single parenteral infusion at a dose of 8 mg/kg for subjects weighing less than 75 kg or at a dose of 600 mg for subjects weighing greater than or equal to 75 kg infused over 60 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| The Maximum Plasma Concentration (Cmax) of Ceftaroline After Administration of Ceftaroline Fosamil at a Dose of 8 mg/kg up to a Maximum Dose of 600 mg Via IV Infusion Over 60 Minutes. | The maximum plasma concentration (Cmax ) occurred around the time of the end of study drug infusion. | 12 hours after infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events (AEs) Reported After Starting Study Drug Administration (Treatment Emergent Adverse Events, TEAEs) by Relationship to Ceftaroline (Related or Unrelated). | A TEAE is any untoward medical occurrence a subject experiences following study drug administration. Subjects were monitored for TEAEs from the start of infusion of ceftaroline fosamil on Study Day 1 through the follow-up contact on Day 7. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor Cerexa | Forest Laboratories | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site | Louisville | Kentucky | 40202 | United States | ||
| Investigational Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ceftaroline | Single group assignment, single dose of 600mg ceftaroline administered intravenously. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ceftaroline | Single group assignment, single dose of 600mg ceftaroline administered intravenously. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | The Maximum Plasma Concentration (Cmax) of Ceftaroline After Administration of Ceftaroline Fosamil at a Dose of 8 mg/kg up to a Maximum Dose of 600 mg Via IV Infusion Over 60 Minutes. | The maximum plasma concentration (Cmax ) occurred around the time of the end of study drug infusion. | per protocol | Posted | Mean | Standard Deviation | ng/mL | 12 hours after infusion |
|
|
AEs were evaluated from the start of study drug infusion to last FU visit, study day 7 (+-2 days).
Serious Adverse Events (SAEs) were evaluated through 30 days after the Ceftaroline infusion.
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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 | Ceftaroline | Single group assignment, single dose of 600mg ceftaroline administered intravenously. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Friedland, MD | Cerexa, Inc. | 510-285-9200 | clinicaltrials@cerexa.com |
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| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000097583 | Ceftaroline |
| D007267 | Injections |
| ID | Term |
|---|---|
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 |
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|
| Signing of Informed Consent Form (ICF) to last follow up (FU) visit, study day 7 (+-2 days). |
| Durham |
| North Carolina |
| 27710 |
| United States |
| Investigational site | Akron | Ohio | 44308 | United States |
| Invetigational Site | Cleveland | Ohio | 44106 | United States |
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Number of Adverse Events (AEs) Reported After Starting Study Drug Administration (Treatment Emergent Adverse Events, TEAEs) by Relationship to Ceftaroline (Related or Unrelated). | A TEAE is any untoward medical occurrence a subject experiences following study drug administration. Subjects were monitored for TEAEs from the start of infusion of ceftaroline fosamil on Study Day 1 through the follow-up contact on Day 7. | per protocol Out of 9 participants analyzed, 1 subject did not receive the full dose of study drug. | Posted | Number | events | Signing of Informed Consent Form (ICF) to last follow up (FU) visit, study day 7 (+-2 days). |
|
|
|
| 1 |
| 9 |
| 5 |
| 9 |
| Extrasystoles | Cardiac disorders | MedDRA (11.1) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Infusion site extravasation | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| ECG Prolonged QT | Investigations | MedDRA (11.1) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
|
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| Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |