Staphylococcal Skin InfectionsPhase 1NCT01026636
A Single-Dose Pharmacokinetics and Safety Study of Ceftobiprole in Pediatric Patients =3 Months to <18 Years of Age
A Phase 1 study testing Ceftobiprole in people with Staphylococcal Skin Infections and Streptococcal Infections, run by Basilea Pharmaceutica.
Trial summary
This study will assess the pharmacokinetics (how drugs are absorbed, distributed in the body and removed over time) and safety of a single dose of ceftobiprole in pediatric patients undergoing treatment with systemic antibiotics and may be used to guide dosing recommendations for ceftobiprole in children. Read more about this study
- Who is it for?
- Ages 3 months to 18 years
- Conditions the study is for
- Staphylococcal Skin Infections, Streptococcal Infections
- What is being tested?
- Ceftobiprole
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- Aug 2007to Apr 2010
- Phase
- Phase 1
- 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 3 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Infants (=3 months to <2 years of age) must have been born at =36 weeks of gestation
- Documented or presumed, or be at risk for, bacterial infection(s) and receiving systemic antibiotic therapy
- Stable medical condition
Who cannot join
- History of drug allergy or hypersensitivity to ß-lactam antibiotics such as penicillins, cephalosporins, or carbapenems
- History of clinically significant cardiac arrhythmia, cystic fibrosis, chronic lung disease associated with abnormal pulmonary function, acute or chronic arthritis
- History of infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
About this study
Official title: An Open-Label Study to Evaluate the Single-Dose Pharmacokinetics and Safety of Ceftobiprole in Pediatric Patients =3 Months to 17<18 Years of Age, Undergoing Treatment With Systemic Antibiotics
This study will assess the pharmacokinetics (how drugs are absorbed, distributed in the body and removed over time) and safety of a single dose of ceftobiprole in pediatric patients undergoing treatment with systemic antibiotics and may be used to guide dosing recommendations for ceftobiprole in children.
Read the detailed description
This purpose of this study will be to assess the pharmacokinetics (how drugs are absorbed, distributed in the body and removed over time) and safety of a single dose of ceftobiprole in pediatric patients undergoing treatment with systemic antibiotics and may be used to guide dosing recommendations for ceftobiprole in children. This study is an open-label (all patients will know the identity of the drug) single-dose, pharmacokinetic study in infants and children =3 months to <18 years of age who are medically stable as judged by the clinical investigator and require therapy with antibiotics. Patients will be given a 2-hour i.v. infusion (given directly into the vein) of 7, 10, or 15 mg/kg ceftobiprole. The study population will be grouped according to the following 4 age groups: =12 to <18 years of age; =6 to <12 years of age; =2 to <6 years of age; and =3 months to <2 years of age. Every attempt will be made to include patients of both sexes in each age group. Safety evaluations will include clinical laboratory tests (hematology, serum chemistry, and urinalysis), pregnancy testing, vital signs, physical examination, monitoring of adverse events, and recording of concomitant medications. Patients will be given a single 2-hour i.v. (given directly into the vein) infusion of ceftobiprole. The total duration of the study is approximately 18 days, including screening and posttreatment.
- Being tested
- Ceftobiprole
- Keywords
- Staphylococcal Skin Infections, Skin Infections, Streptococcal Infections
- Medical subject headings
- Staphylococcal Skin Infections, Streptococcal Infections, Cellulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CeftobiproleDrug
Also called Ceftobiprole 7mg/kg - 15kg/kg per day as 2h infusion
| Study group | Role | What they receive |
|---|---|---|
| Ceftobiprole | Experimental | Ceftobiprole 7mg/kg - 15mg/kg per day as 2h infusion Receives: Drug: Ceftobiprole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the pharmacokinetics of ceftobiprole when administered as a single dose of 7, 10, or 15 mg/kg in pediatric patients =3 months to <18 years of age who require therapeutic or prophylactic therapy with systemic antibiotics
Measured: The total duration of the study is approximately 18 days, including screening and posttreatment with prescreening, Day 1 and Day 2 post treatment
Secondary outcomes (1)
No Secondary Outcomes
Measured: 16d
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2009 (estimated)
- Study startAug 2007
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staphylococcal Skin 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 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Basilea Pharmaceutica
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01026636
- Sponsor's protocol ID
- CR012304
- Other IDs
- CSI-1001
- Status last verified
- Jul 2012
- First submitted
- 3 Dec 2009
- Last updated
- 27 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Evaluate the Single-Dose Pharmacokinetics and Safety of Ceftobiprole in Pediatric Patients =3 Months to 17<18 Years of Age, Undergoing Treatment With Systemic Antibiotics
- ClinicalTrials.gov ID
- NCT01026636
- Acronym / sponsor ID
- CR012304
- Keywords
- Staphylococcal Skin Infections, Skin Infections, Streptococcal Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Basilea PharmaceuticaIndustry (pharma, biotech, devices)
- Collaborators
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Study start
- Aug 2007
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 4 Dec 2009 (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.
This study will assess the pharmacokinetics (how drugs are absorbed, distributed in the body and removed over time) and safety of a single dose of ceftobiprole in pediatric patients undergoing treatment with systemic antibiotics and may be used to guide dosing recommendations for ceftobiprole in children.
Detailed description
This purpose of this study will be to assess the pharmacokinetics (how drugs are absorbed, distributed in the body and removed over time) and safety of a single dose of ceftobiprole in pediatric patients undergoing treatment with systemic antibiotics and may be used to guide dosing recommendations for ceftobiprole in children. This study is an open-label (all patients will know the identity of the drug) single-dose, pharmacokinetic study in infants and children =3 months to <18 years of age who are medically stable as judged by the clinical investigator and require therapy with antibiotics. Patients will be given a 2-hour i.v. infusion (given directly into the vein) of 7, 10, or 15 mg/kg ceftobiprole. The study population will be grouped according to the following 4 age groups: =12 to <18 years of age; =6 to <12 years of age; =2 to <6 years of age; and =3 months to <2 years of age. Every attempt will be made to include patients of both sexes in each age group. Safety evaluations will include clinical laboratory tests (hematology, serum chemistry, and urinalysis), pregnancy testing, vital signs, physical examination, monitoring of adverse events, and recording of concomitant medications. Patients will be given a single 2-hour i.v. (given directly into the vein) infusion of ceftobiprole. The total duration of the study is approximately 18 days, including screening and posttreatment.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ceftobiprole | Experimental | Drug: CeftobiproleCeftobiprole 7mg/kg - 15mg/kg per day as 2h infusion |
Who may qualify
- Ages
- 3 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Infants (=3 months to <2 years of age) must have been born at =36 weeks of gestation
- Documented or presumed, or be at risk for, bacterial infection(s) and receiving systemic antibiotic therapy
- Stable medical condition
Key exclusion criteria (3 listed)
- History of drug allergy or hypersensitivity to ß-lactam antibiotics such as penicillins, cephalosporins, or carbapenems
- History of clinically significant cardiac arrhythmia, cystic fibrosis, chronic lung disease associated with abnormal pulmonary function, acute or chronic arthritis
- History of infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
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 |
|---|---|---|
| CeftobiproleAlso: Ceftobiprole 7mg/kg - 15kg/kg per day as 2h infusion | Drug | Ceftobiprole |
Primary outcome
Evaluate the pharmacokinetics of ceftobiprole when administered as a single dose of 7, 10, or 15 mg/kg in pediatric patients =3 months to <18 years of age who require therapeutic or prophylactic therapy with systemic antibiotics
Time frame: The total duration of the study is approximately 18 days, including screening and posttreatment with prescreening, Day 1 and Day 2 post treatment
1 secondary outcome
No Secondary Outcomes
Time frame: 16d
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 27 Jul 2012.
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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.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ceftobiprole in people with Staphylococcal Skin Infections and Streptococcal Infections, run by Basilea Pharmaceutica.
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 27 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Evaluate the pharmacokinetics of ceftobiprole when administered as a single dose of 7, 10, or 15 mg/kg in pediatric patients =3 months to <18 years of age who require therapeutic or prophylactic therapy with systemic antibiotics (time frame: The total duration of the study is approximately 18 days, including screening and posttreatment with prescreening, Day 1 and Day 2 post treatment). 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 27 Jul 2012.