InfectionsPhase 4NCT01298843
Study of Blood Levels of Ceftaroline Fosamil in Children Who Are Receiving Antibiotic Therapy in the Hospital
A Phase 4 study testing Ceftaroline fosamil in people with Infections, run by Forest Laboratories at 15 sites in United States.
Trial summary
The purpose of this study is to assess blood levels of Ceftaroline fosamil in children. Read more about this study
- Who is it for?
- Ages Up to 11 years
- Conditions the study is for
- Infections
- What is being tested?
- Ceftaroline fosamil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 15 sitesUnited States
- Study dates
- Apr 2011to Feb 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 Up to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects must meet the following inclusion criteria:
- Male or female children with ages from birth to younger than 12 years
- Hospitalized and receiving systemic antibiotic therapy for treatment of a suspected or confirmed infection
- Sufficient intravascular access
- Negative urine pregnancy test
- Written informed consent from parent(s)and verbal informed assent from subject
Who cannot join
- Subjects must NOT meet any of the following exclusion criteria:
- History of any hypersensitivity or allergic reaction to any β-lactam antimicrobial
- Past or current history of epilepsy or seizure disorder
- Moderate or severe renal impairment
- If female, currently pregnant or nursing
- Aspartate aminotransferase, alanine aminotransferase, or total bilirubin level > 3 times upper limit of normal
Show all 9Show fewer
- Any condition that would make the subject, in the opinion of the Investigator, unsuitable for the study
- Use of probenecid within 3 days prior to dosing
- Receipt of a blood transfusion during the 24-hour period before enrollment
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Investigational Site
Akron, Ohio, 44308
Investigational Site
Cleveland, Ohio, 44106
Investigational Site
Cleveland, Ohio, 44109
Investigational Site
Forth Worth, Texas, 76102
Investigational Site
Indianapolis, Indiana, 46202
Investigational Site
Jackson, Mississippi, 39216
Investigational Site
Little Rock, Arkansas, 72202
Investigational Site
Louisville, Kentucky, 40202
Investigational Site
Morgantown, West Virginia, 26506
Investigational Site
Omaha, Nebraska, 68198
Investigational Site
Orange, California, 92868
Investigational Site
Phoenix, Arizona, 85008
Investigational Site
San Diego, California, 92123
Investigational Site
Shreveport, Louisiana, 71113
Investigational site
Toledo, Ohio, 43606
About this study
Official title: Pharmacokinetics of a Single Dose of Ceftaroline Fosamil in Children Ages Birth to Younger Than 12 Years With Suspected or Confirmed Infection
The purpose of this study is to assess blood levels of Ceftaroline fosamil in children.
Read the detailed description
To characterize single dose pharmacokinetics of Ceftaroline fosamil in children.
- Conditions
- Infections
- Being tested
- Ceftaroline fosamil
- Keywords
- Confirmed or Suspected Infections
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ceftaroline fosamilDrug
Single dose of 15 mg/kg (up to 600 mg) by intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Study of Blood Levels of Ceftaroline Fosamil | Other | Study of Blood Levels of Ceftaroline Fosamil in Children Who Are Receiving Antibiotic Therapy in the Hospital Receives: Drug: Ceftaroline fosamil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic profile of Ceftaroline fosamil, plasma concentrations time profile of ceftaroline fosamil by patient, age cohort and dosage level, and Safety and tolerability of ceftaroline fosamil following a single dose of ceftaroline.
This study has 3 primary outcome measures: plasma concentration of ceftaroline fosamil and its metabolites from blood samples after a single dose; PK profile of ceftaroline, and safety, where number of subjects with serious and non-serious adverse events and type of frequency of adverse events will be reported.
Measured: Up to 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2011 (estimated)
- Study startApr 2011
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionsStudies 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 4
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forest Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01298843
- Sponsor's protocol ID
- P903-21
- Status last verified
- May 2014
- First submitted
- 15 Feb 2011
- Last updated
- 14 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of a Single Dose of Ceftaroline Fosamil in Children Ages Birth to Younger Than 12 Years With Suspected or Confirmed Infection
- ClinicalTrials.gov ID
- NCT01298843
- Acronym / sponsor ID
- P903-21
- Conditions
- Infections
- Keywords
- Confirmed or Suspected Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Forest LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 18 Feb 2011 (estimated)
- Results
- Not posted in the source record
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 assess blood levels of Ceftaroline fosamil in children.
Detailed description
To characterize single dose pharmacokinetics of Ceftaroline fosamil in children.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study of Blood Levels of Ceftaroline Fosamil | Other | Drug: Ceftaroline fosamilStudy of Blood Levels of Ceftaroline Fosamil in Children Who Are Receiving Antibiotic Therapy in the Hospital |
Who may qualify
- Ages
- Up to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Male or female children with ages from birth to younger than 12 years
- Hospitalized and receiving systemic antibiotic therapy for treatment of a suspected or confirmed infection
- Sufficient intravascular access
- Negative urine pregnancy test
- Written informed consent from parent(s)and verbal informed assent from subject
Key exclusion criteria (9 listed)
- History of any hypersensitivity or allergic reaction to any β-lactam antimicrobial
- Past or current history of epilepsy or seizure disorder
- Moderate or severe renal impairment
- If female, currently pregnant or nursing
- Aspartate aminotransferase, alanine aminotransferase, or total bilirubin level > 3 times upper limit of normal
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 |
|---|---|---|
| Ceftaroline fosamilSingle dose of 15 mg/kg (up to 600 mg) by intravenous infusion | Drug | Study of Blood Levels of Ceftaroline Fosamil |
Primary outcome
Pharmacokinetic profile of Ceftaroline fosamil, plasma concentrations time profile of ceftaroline fosamil by patient, age cohort and dosage level, and Safety and tolerability of ceftaroline fosamil following a single dose of ceftaroline.
Time frame: Up to 5 days
This study has 3 primary outcome measures: plasma concentration of ceftaroline fosamil and its metabolites from blood samples after a single dose; PK profile of ceftaroline, and safety, where number of subjects with serious and non-serious adverse events and type of frequency of adverse events will be reported.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ceftaroline fosamil in people with Infections, run by Forest Laboratories at 15 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 6 inclusion and 9 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 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pharmacokinetic profile of Ceftaroline fosamil, plasma concentrations time profile of ceftaroline fosamil by patient, age cohort and dosage level, and Safety and tolerability of ceftaroline fosamil following a single dose of ceftaroline. (time frame: Up to 5 days). 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 May 2014.