InfectionPhase 1NCT00633126
Pharmacokinetics of Ceftaroline in Subjects 12 to 17 Years of Age
A Phase 1 study testing ceftaroline in people with Infection, run by Forest Laboratories at 4 sites in United States.
Trial summary
The purpose of this study is to determine the pharmacokinetics of ceftaroline in pediatric subjects Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Infection
- What is being tested?
- ceftaroline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 4 sitesUnited States
- Study dates
- Mar 2008to Feb 2009
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Hospitalized and receiving antibiotic therapy for treatment of a suspected infection of any type
- Body mass index (weight [kg]/height squared [m2]) of no more than 30
- Males and females between 12 and 17 years of age, inclusive
Who cannot join
- History of any hypersensitivity or allergic reaction to any β-lactam antimicrobial
- Past or current history of epilepsy or seizure disorder
- Critically ill or unstable patients
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Investigational site
Akron, Ohio, 44308
Invetigational Site
Cleveland, Ohio, 44106
Investigational Site
Durham, North Carolina, 27710
Investigational Site
Louisville, Kentucky, 40202
About this study
Official title: Pharmacokinetics of a Single Dose of Ceftaroline in Subjects 12 to 17 Years of Age Receiving Antibiotic Therapy
The purpose of this study is to determine the pharmacokinetics of ceftaroline in pediatric subjects
Read the detailed description
The purpose of this study is to determine the pharmacokinetics profile of ceftaroline in pediatric subjects
- Conditions
- Infection
- Being tested
- ceftaroline
- Keywords
- PK, Pharmacokinetics
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ceftarolineDrug
Also called ceftaroline for injection, ceftaroline fosamil
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.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | ceftaroline Receives: Drug: ceftaroline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 hours after infusion
Secondary outcomes (1)
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.
Measured: Signing of Informed Consent Form (ICF) to last follow up (FU) visit, study day 7 (+-2 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forest Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor Cerexa, Study director, Forest Laboratories
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00633126
- Sponsor's protocol ID
- P903-15
- Status last verified
- Feb 2017
- First submitted
- 3 Mar 2008
- Last updated
- 14 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of a Single Dose of Ceftaroline in Subjects 12 to 17 Years of Age Receiving Antibiotic Therapy
- ClinicalTrials.gov ID
- NCT00633126
- Acronym / sponsor ID
- P903-15
- Conditions
- Infection
- Keywords
- PK, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Forest LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 11 Mar 2008 (estimated)
- Results
- Posted 12 Feb 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the pharmacokinetics of ceftaroline in pediatric subjects
Detailed description
The purpose of this study is to determine the pharmacokinetics profile of ceftaroline in pediatric subjects
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: ceftarolineceftaroline |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Hospitalized and receiving antibiotic therapy for treatment of a suspected infection of any type
- Body mass index (weight [kg]/height squared [m2]) of no more than 30
- Males and females between 12 and 17 years of age, inclusive
Key exclusion criteria (3 listed)
- History of any hypersensitivity or allergic reaction to any β-lactam antimicrobial
- Past or current history of epilepsy or seizure disorder
- Critically ill or unstable patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ceftarolineAlso: ceftaroline for injection, ceftaroline fosamilSingle 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. | Drug | A |
Primary outcome
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.
Time frame: 12 hours after infusion
The maximum plasma concentration (Cmax ) occurred around the time of the end of study drug infusion.
1 secondary outcome
Number of Adverse Events (AEs) Reported After Starting Study Drug Administration (Treatment Emergent Adverse Events, TEAEs) by Relationship to Ceftaroline (Related or Unrelated).
Time frame: Signing of Informed Consent Form (ICF) to last follow up (FU) visit, study day 7 (+-2 days).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor Cerexa study director
Forest Laboratories
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ceftaroline in people with Infection, run by Forest Laboratories at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 12 hours after infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2017.