Infections, PediatricsPhase 2/3NCT01400867
Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Complicated Skin Infections
A Phase 2/3 study testing Ceftaroline fosamil, Vancomycin +/- Aztreonam or Cefazolin +/- Aztreonam and Cephalexin or Clindamycin or Linezolid in people with Infections, Pediatrics, run by Forest Laboratories at 71 sites in 10 countries.
Trial summary
This is a study of safety, effectiveness, blood levels and tolerance of Ceftaroline fosamil in children with skin infections receiving antibiotic therapy in the hospital. Read more about this study
- Who is it for?
- Ages 2 months to 17 years
- Conditions the study is for
- Infections, Pediatrics
- What is being tested?
- Ceftaroline fosamil, Vancomycin +/- Aztreonam or Cefazolin +/- Aztreonam and Cephalexin or Clindamycin or Linezolid
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 71 sitesin 10 countries
- Study dates
- Dec 2011to Jul 2014
- Phase
- Phase 2/3
- 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 2 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female, 2 months to < 18 years old.
- Presence of ABSSSI warranting initial hospitalization.
- Presence of ABSSSI with measurable margins of erythema, that includes deeper and/or extensive soft tissue involvement, or requires significant therapeutic surgical intervention
Who cannot join
- Documented history of any hypersensitivity or allergic reaction to vancomycin, aztreonam, or any β-lactam antimicrobial
- Uncomplicated skin and soft tissue infections
- More than 24 hours of prior antimicrobial therapy ≤ 96 hours before randomization.
- Requirement for any concomitant systemic antimicrobial therapy
- History of seizures, excluding well-documented febrile seizure of childhood.
- Clinical signs or suspicion of meningitis
Trial locations and contacts
71 sites in 10 countries.
71 sites in 10 countries
United States28 sites
Investigational Site - Akron
Akron, Ohio
Investigational Site - Atlanta
Atlanta, Georgia
Investigational Site - Austin 1
Austin, Texas
Investigational Site - Baltimore
Baltimore, Maryland
Investigational Site - Brooklyn
Brooklyn, New York
Investigational Site - Charleston
Charleston, South Carolina
Investigational Site - Chicago 1
Chicago, Illinois
Investigational Site - Chicago 2
Chicago, Illinois
Investigational Site - Cleveland 1
Cleveland, Ohio
Investigational Site - Cleveland 2
Cleveland, Ohio
Investigational Site - Detroit
Detroit, Michigan
Investigational Site - Fort Worth
Fort Worth, Texas
Investigational Site - Jacksonville
Jacksonville, Florida
Investigational Site - Memphis
Memphis, Tennessee
Investigational Site - Morgantown
Morgantown, West Virginia
Investigational Site - New Hyde Park
New Hyde Park, New York
Investigational Site - Norfolk
Norfolk, Virginia
Investigational Site - Orange
Orange, California
Investigational Site - Phoenix
Phoenix, Arizona
Investigational Site - Pittsburgh
Pittsburgh, Pennsylvania
Investigational Site - Richmond
Richmond, Virginia
Investigational Site - Rochester
Rochester, New York
Investigational Site - San Diego
San Diego, California
Investigational Site - Seattle
Seattle, Washington
Investigational Site - Shreveport
Shreveport, Louisiana
Investigational Site - Springfield
Springfield, Illinois
Investigational Site - Bronx
The Bronx, New York
Investigational Site - Toledo
Toledo, Ohio
Argentina8 sites
Investigational Site - Buenos Aires 1
Buenos Aires
Investigational Site - Buenos Aires 2
Buenos Aires
Investigational Site - Buenos Aires 3
Buenos Aires
Investigational Site - Buenos Aires 4
Buenos Aires
Investigational Site - Buenos Aires 5
Buenos Aires
Investigational Site - Buenos Aires 6
Buenos Aires
Investigational Site - Santa Fe 1
Santa Fe
Investigational Site - Santa Fe 2
Santa Fe
Spain8 sites
Investigational Site - Badalona
Badalona
Investigational Site - Esplugues de Llobregat
Esplugues de Llobregat
Investigational Site - Getafe
Getafe
Investigational Site - Madrid 1
Madrid
Investigational Site - Madrid 2
Madrid
Investigational Site - Madrid 3
Madrid
Investigational Site - Santiago de Compostela
Santiago de Compostela
Investigational Site - Valencia
Valencia
Poland6 sites
Investigational Site - Bydgoszcz 1
Bydgoszcz
Investigational Site - Bydgoszcz 2
Bydgoszcz
Investigational Site - Lodz
Lodz
Investigational Site - Lublin
Lublin
Investigational Site - Rzeszow
Rzeszów
Investigational Site - Warszawa
Warsaw
Romania5 sites
Investigational Site - Bucharest 1
Bucharest
Investigational Site - Bucharest 2
Bucharest
Investigational Site - Constanta
Constanța
Investigational Site - Tirgu Mures
Târgu Mureş
Investigational Site - Timisoara
Timișoara
Chile4 sites
Investigational Site - Puente Alto
Puente Alto, Santiago Metropolitan
Investigational Site - San Ramon
San Ramón, Santiago Metropolitan
Investigational Site - Vina Del Mar
Viña del Mar
Investigational Site - Vitacura
Vitacura, Santiago Metropolitan
Latvia4 sites
Investigational Site - Daugavpils
Daugavpils
Investigational Site - Liepaja
Liepāja
Investigational Site - Rezekne
Rēzekne
Investigational Site - Riga
Riga
South Africa4 sites
Investigational Site - Cape Town 1
Cape Town
Investigational Site - Cape Town 2
Cape Town
Investigational Site - Cape Town 3
Cape Town
Investigational Site - Johannesburg
Johannesburg
Georgia2 sites
Investigational Site - Tbilisi 1
Tbilisi
Investigational Site - Tbilisi 2
Tbilisi
Lithuania2 sites
Investigational Site - Kaunas
Kaunas
Investigational Site - Vilnius
Vilnius
About this study
Official title: A Multicenter, Randomized, Observer-Blinded, Active-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Ceftaroline Versus Comparator in Pediatric Subjects With Acute Bacterial Skin and Skin Structure Infections
This is a study of safety, effectiveness, blood levels and tolerance of Ceftaroline fosamil in children with skin infections receiving antibiotic therapy in the hospital.
Read the detailed description
To evaluate safety, effectiveness, pharmacokinetics and tolerance of Ceftaroline fosamil in children who are initially hospitalized with Acute Bacterial Skin and Skin Structure Infections (ABSSSI).
- Conditions
- Infections, Pediatrics
- Being tested
- Ceftaroline fosamil, Vancomycin +/- Aztreonam or Cefazolin +/- Aztreonam, Cephalexin or Clindamycin or Linezolid
- Keywords
- Infections, Pediatrics, Teflaro, cephalosporin
- 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
Also called Teflaro, PPI-0903, TAK-599, TAK599
Subjects ≥ 6 months old: 12 mg/kg IV for subjects weighing ≤ 33 kg and 400 mg for subjects weighing > 33 kg will be infused over 60 (± 10) minutes every 8 hours (q8h) (± 1 hour)
Subjects < 6 months old: 8mg/kg infused over 60 (± 10) minutes every 8 hours (q8h) (± 1 hour)
Vancomycin +/- Aztreonam or Cefazolin +/- AztreonamDrug
Vancomycin 15mg/kg IV over 60 minutes (or a maximum of 10mg/min whichever is longer) +/- Aztreonam 30 mg/kg IV every 8 hours over 60 minutes (for infections involving gram negative pathogen suspected or confirmed)
Cefazolin 75mg/kg IV divided every 8 hours over 60 minutes (for sites that do not empirically cover for MRSA) +/- Aztreonam 30 mg/kg IV every 8 hours over 60 minutes (for infections involving gram negative pathogen suspected or confirmed
Cephalexin or Clindamycin or LinezolidDrug
Possible oral switch on or after study day 4.
Cephalexin: 25 mg/kg q6h PO or Clindamycin: 10 mg/kg q8h PO or Linezolid 600mg q12h (cohort 1) or 10 mg/kg q8h (cohorts 2,3 and 4) PO.
| Study group | Role | What they receive |
|---|---|---|
| Ceftaroline fosamil | Experimental | Not described Receives: Drug: Ceftaroline fosamil; Drug: Cephalexin or Clindamycin or Linezolid |
| Comparators | Active comparator | Vancomycin +/- Aztreonam Cefazolin +/- Aztreonam Receives: Drug: Vancomycin +/- Aztreonam or Cefazolin +/- Aztreonam; Drug: Cephalexin or Clindamycin or Linezolid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety and tolerability of ceftaroline versus comparator in pediatric subjects ages 2 months to < 18 years with ABSSSI.
Evaluate the safety and tolerability of IV administered ceftaroline fosamil in children with skin infections. Summaries of AEs, SAEs, deaths, laboratory evaluations (hematology studies, comprehensive and metabolic panel), pain scales, vital signs, and physical examinations will be provided for each treatment group.
Measured: Between 26 and 50 days.
Secondary outcomes (2)
Evaluate the efficacy of ceftaroline versus comparator in pediatric subjects ages 2 months to < 18 years with ABSSSI.
The number and percentage of subjects in each treatment group classified as clinical cure in the Modified Intent to Treat (MITT) and Clinical Evaluable (CE) populations at Day 3, EOIV, EOT and TOC.
Measured: Between 1 and 5 days
Evaluate the pharmacokinetics of ceftaroline versus comparator in pediatric subjects ages 2 months to < 18 years with ABSSSI.
Analyze concentrations of ceftaroline fosamil, ceftaroline, and M-1 in plasma, and if available, in cerebrospinal fluid (CSF; if collected as part of routine medical care)
Measured: Between 1 and 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2011 (estimated)
- Study startDec 2011
- Primary completionMay 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infections, PediatricsStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forest Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01400867
- Sponsor's protocol ID
- P903-23
- Status last verified
- Jan 2015
- First submitted
- 19 Jul 2011
- Last updated
- 13 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Observer-Blinded, Active-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Ceftaroline Versus Comparator in Pediatric Subjects With Acute Bacterial Skin and Skin Structure Infections
- ClinicalTrials.gov ID
- NCT01400867
- Acronym / sponsor ID
- P903-23
- Conditions
- Infections, Pediatrics
- Keywords
- Infections, Pediatrics, Teflaro, cephalosporin
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Forest LaboratoriesIndustry (pharma, biotech, devices)
- Collaborators
- AstraZeneca
- Study start
- Dec 2011
- Primary completion
- May 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 22 Jul 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.
This is a study of safety, effectiveness, blood levels and tolerance of Ceftaroline fosamil in children with skin infections receiving antibiotic therapy in the hospital.
Detailed description
To evaluate safety, effectiveness, pharmacokinetics and tolerance of Ceftaroline fosamil in children who are initially hospitalized with Acute Bacterial Skin and Skin Structure Infections (ABSSSI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ceftaroline fosamil | Experimental | Drug: Ceftaroline fosamil, Drug: Cephalexin or Clindamycin or Linezolid |
| Comparators | Active comparator | Drug: Vancomycin +/- Aztreonam or Cefazolin +/- Aztreonam, Drug: Cephalexin or Clindamycin or LinezolidVancomycin +/- Aztreonam Cefazolin +/- Aztreonam |
Who may qualify
- Ages
- 2 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Male or female, 2 months to < 18 years old.
- Presence of ABSSSI warranting initial hospitalization.
- Presence of ABSSSI with measurable margins of erythema, that includes deeper and/or extensive soft tissue involvement, or requires significant therapeutic surgical intervention
Key exclusion criteria (6 listed)
- Documented history of any hypersensitivity or allergic reaction to vancomycin, aztreonam, or any β-lactam antimicrobial
- Uncomplicated skin and soft tissue infections
- More than 24 hours of prior antimicrobial therapy ≤ 96 hours before randomization.
- Requirement for any concomitant systemic antimicrobial therapy
- History of seizures, excluding well-documented febrile seizure of childhood.
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 fosamilAlso: Teflaro, PPI-0903, TAK-599, TAK599Subjects ≥ 6 months old: 12 mg/kg IV for subjects weighing ≤ 33 kg and 400 mg for subjects weighing > 33 kg will be infused over 60 (± 10) minutes every 8 hours (q8h) (± 1 hour) Subjects < 6 months old: 8mg/kg infused over 60 (± 10) minutes every 8 hours (q8h) (± 1 hour) | Drug | Ceftaroline fosamil |
| Vancomycin +/- Aztreonam or Cefazolin +/- AztreonamVancomycin 15mg/kg IV over 60 minutes (or a maximum of 10mg/min whichever is longer) +/- Aztreonam 30 mg/kg IV every 8 hours over 60 minutes (for infections involving gram negative pathogen suspected or confirmed) Cefazolin 75mg/kg IV divided every 8 hours over 60 minutes (for sites that do not empirically cover for MRSA) +/- Aztreonam 30 mg/kg IV every 8 hours over 60 minutes (for infections involving gram negative pathogen suspected or confirmed | Drug | Comparators |
| Cephalexin or Clindamycin or LinezolidPossible oral switch on or after study day 4. Cephalexin: 25 mg/kg q6h PO or Clindamycin: 10 mg/kg q8h PO or Linezolid 600mg q12h (cohort 1) or 10 mg/kg q8h (cohorts 2,3 and 4) PO. | Drug | Ceftaroline fosamil, Comparators |
Primary outcome
Evaluate the safety and tolerability of ceftaroline versus comparator in pediatric subjects ages 2 months to < 18 years with ABSSSI.
Time frame: Between 26 and 50 days.
Evaluate the safety and tolerability of IV administered ceftaroline fosamil in children with skin infections. Summaries of AEs, SAEs, deaths, laboratory evaluations (hematology studies, comprehensive and metabolic panel), pain scales, vital signs, and physical examinations will be provided for each treatment group.
2 secondary outcomes
Evaluate the efficacy of ceftaroline versus comparator in pediatric subjects ages 2 months to < 18 years with ABSSSI.
Time frame: Between 1 and 5 days
Evaluate the pharmacokinetics of ceftaroline versus comparator in pediatric subjects ages 2 months to < 18 years with ABSSSI.
Time frame: Between 1 and 5 days
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 13 Jan 2015.
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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.
71 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ceftaroline fosamil, Vancomycin +/- Aztreonam or Cefazolin +/- Aztreonam and Cephalexin or Clindamycin or Linezolid in people with Infections, Pediatrics, run by Forest Laboratories at 71 sites in 10 countries.
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 6 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 13 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 71 sites in United States, Argentina, Spain, Poland, Romania and 5 more countries. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 safety and tolerability of ceftaroline versus comparator in pediatric subjects ages 2 months to < 18 years with ABSSSI. (time frame: Between 26 and 50 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 13 Jan 2015.