InfectionsPhase 4NCT01669980
Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Complicated Community Acquired Pneumonia (CABP)
A Phase 4 study testing Ceftaroline fosamil and IV Ceftriaxone and Vancomycin in people with Infections and Pneumonia, run by Forest Laboratories at 21 sites in 4 countries.
Trial summary
This is a study of safety and effectiveness of ceftaroline fosamil in children with Complicated Community-acquired Pneumonia receiving antibiotic therapy in the hospital. Read more about this study
- Who is it for?
- Ages 2 months to 18 years
- Conditions the study is for
- Infections, Pneumonia
- What is being tested?
- Ceftaroline fosamil and IV Ceftriaxone and Vancomycin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 21 sitesin 4 countries
- Study dates
- Oct 2012to Aug 2014
- 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 2 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Presence of CABP warranting 3 days of initial hospitalization
- Confirmed presence of indicators of complicated CABP
Who cannot join
- Hypersensitivity or allergic reaction to vancomycin or any β-lactam antimicrobial
- Confirmed or suspected infection with a pathogen known to be resistant to IV study drugs or known infection at baseline with a sole atypical organism
- Confirmed or suspected respiratory tract infection attributable to sources other than community acquired bacterial pneumonia
- Non-infectious causes of pulmonary infiltrates
Trial locations and contacts
21 sites in 4 countries.
21 sites in 4 countries
United States13 sites
Investigational Site
Boston, Massachusetts
Investigational Site
Cleveland, Ohio
Study site
Houston, Texas
Investigational Site
Long Beach, California
Investigational Site
Memphis, Tennessee
Investigational Site
Morgantown, West Virginia
Investigational Site
Norfolk, Virginia
Study site
Oakland, California
Investigational Site
Orange County, California
Investigational Site
Pittsburgh, Pennsylvania
Study site
Salt Lake City, Utah
Investigational Site
San Diego, California
Investigational Site
Toledo, Ohio
Ukraine4 sites
Investigational Site
Donetsk
Investigational Site
Ivano-Frankivsk
Investigational Site
Kryvyi Rih
Investigational Site
Kyiv
Georgia3 sites
Investigational Site 1
Tbilisi
Investigational Site 2
Tbilisi
Investigational Site 3
Tbilisi
About this study
Official title: A Multicenter, Randomized, Observer-Blinded, Active-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Ceftaroline Versus Ceftriaxone Plus Vancomycin in Pediatric Subjects With Complicated Community-acquired Bacterial Pneumonia (CABP)
This is a study of safety and effectiveness of ceftaroline fosamil in children with Complicated Community-acquired Pneumonia receiving antibiotic therapy in the hospital.
Read the detailed description
To evaluate safety, effectiveness, pharmacokinetics and tolerance of ceftaroline fosamil in pediatric subjects ages 2 months to < 18 years who are initially hospitalized with Complicated Community Acquired Bacterial Pneumonia (CABP) at high risk of infection due to methicillin-resistant Staphylococcus aureus (MRSA)
- Conditions
- Infections, Pneumonia
- Being tested
- Ceftaroline fosamil, IV Ceftriaxone and Vancomycin
- Keywords
- Infections, Pediatrics, Teflaro, Ceftriaxone, cephalosporin, Vancomycin, Clindamycin, Amoxicillin Clavulanate, Linezolid, MRSA, pneumonia
- Medical subject headings
- Infections, Pneumonia
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: IV ceftaroline fosamil 15 mg/kg (or 600 mg if > 40 kg) infused over 120 (± 10) minutes q8h (± 1 hour)
- Subjects < 6 months: IV ceftaroline fosamil 10 mg/kg infused over 120 (± 10) minutes q8h (± 1 hour)
Optional Oral Switch:
- PO amoxicillin clavulanate 45 to 90 mg/kg/day divided q12h
- PO clindamycin 13 mg/kg/dose
- PO linezolid 600 mg q12h (Cohort 1) or 10 mg/kg q8h
IV Ceftriaxone and VancomycinDrug
- IV ceftriaxone 75 mg/kg/day (up to 4 g/day) divided equally every 12 hours (q12h) (± 2 hours) infused over 30 (± 10) minutes AND
- IV vancomycin 15 mg/kg every 6 hours (q6h) (± 1 hour) infused over at least 60 minutes.
Optional Oral Switch:
- PO amoxicillin clavulanate 45 to 90 mg/kg/day divided q12h
- PO clindamycin 13 mg/kg/dose
- PO linezolid 600 mg q12h (Cohort 1) or 10 mg/kg q8h
| Study group | Role | What they receive |
|---|---|---|
| Ceftaroline fosamil | Experimental | Not described Receives: Drug: Ceftaroline fosamil |
| IV Ceftriaxone and Vancomycin | Active comparator | Not described Receives: Drug: IV Ceftriaxone and Vancomycin |
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 ceftriaxone plus vancomycin in pediatric subjects ages 2 months to < 18 years with complicated community-acquired bacterial pneumonia (CABP)
Evaluate the safety and tolerability of IV administered ceftaroline fosamil in children with complicated CABP. Summaries of patient AEs, SAEs, deaths, discontinuations due to AEs, laboratory evaluations (hematology studies, comprehensive and metabolic panel), and vital signs will be provided for each treatment group.
Measured: between 1 and 57 days
Secondary outcomes (2)
To evaluate the efficacy of ceftaroline versus ceftriaxone plus vancomycin in pediatric subjects with complicated CABP at high risk of infection due to methicillin-resistant Staphylococcus aureus (MRSA).
Evaluate the efficacy of ceftaroline versus ceftriaxone plus vancomycin in pediatric subjects with complicated CABP at high risk of infection due to methicillin-resistant Staphylococcus aureus (MRSA) by assessing clinical stability of the subject at study day 4 and clinical outcome at End of IV, End of Treatment and Test of Cure.
Measured: between 4 and 57 days
Evaluate the pharmacokinetics of ceftaroline in pediatric subjects with complicated CABP at high risk of infection due to methicillin-resistant Staphylococcus aureus (MRSA)
Analyze concentrations of ceftaroline, ceftaroline fosamil (prodrug), and ceftaroline M-1 (inactive metabolite) in plasma, and, if available, in cerebrospinal fluid (CSF, if collected as part of standard of care)
Measured: between 4 and 57 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2012 (estimated)
- Study startOct 2012
- Primary completionMay 2014
- Study completionAug 2014
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 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
- NCT01669980
- Sponsor's protocol ID
- P903-24
- Status last verified
- Oct 2015
- First submitted
- 17 Aug 2012
- Last updated
- 2 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Observer-Blinded, Active-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Ceftaroline Versus Ceftriaxone Plus Vancomycin in Pediatric Subjects With Complicated Community-acquired Bacterial Pneumonia (CABP)
- ClinicalTrials.gov ID
- NCT01669980
- Acronym / sponsor ID
- P903-24
- Conditions
- Infections, Pneumonia
- Keywords
- Infections, Pediatrics, Teflaro, Ceftriaxone, cephalosporin, Vancomycin, Clindamycin, Amoxicillin Clavulanate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Forest LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- May 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 21 Aug 2012 (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 and effectiveness of ceftaroline fosamil in children with Complicated Community-acquired Pneumonia receiving antibiotic therapy in the hospital.
Detailed description
To evaluate safety, effectiveness, pharmacokinetics and tolerance of ceftaroline fosamil in pediatric subjects ages 2 months to < 18 years who are initially hospitalized with Complicated Community Acquired Bacterial Pneumonia (CABP) at high risk of infection due to methicillin-resistant Staphylococcus aureus (MRSA)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ceftaroline fosamil | Experimental | Drug: Ceftaroline fosamil |
| IV Ceftriaxone and Vancomycin | Active comparator | Drug: IV Ceftriaxone and Vancomycin |
Who may qualify
- Ages
- 2 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Presence of CABP warranting 3 days of initial hospitalization
- Confirmed presence of indicators of complicated CABP
Key exclusion criteria (4 listed)
- Hypersensitivity or allergic reaction to vancomycin or any β-lactam antimicrobial
- Confirmed or suspected infection with a pathogen known to be resistant to IV study drugs or known infection at baseline with a sole atypical organism
- Confirmed or suspected respiratory tract infection attributable to sources other than community acquired bacterial pneumonia
- Non-infectious causes of pulmonary infiltrates
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, TAK599* Subjects ≥ 6 months: IV ceftaroline fosamil 15 mg/kg (or 600 mg if > 40 kg) infused over 120 (± 10) minutes q8h (± 1 hour) * Subjects < 6 months: IV ceftaroline fosamil 10 mg/kg infused over 120 (± 10) minutes q8h (± 1 hour) Optional Oral Switch: * PO amoxicillin clavulanate 45 to 90 mg/kg/day divided q12h * PO clindamycin 13 mg/kg/dose * PO linezolid 600 mg q12h (Cohort 1) or 10 mg/kg q8h | Drug | Ceftaroline fosamil |
| IV Ceftriaxone and Vancomycin* IV ceftriaxone 75 mg/kg/day (up to 4 g/day) divided equally every 12 hours (q12h) (± 2 hours) infused over 30 (± 10) minutes AND * IV vancomycin 15 mg/kg every 6 hours (q6h) (± 1 hour) infused over at least 60 minutes. Optional Oral Switch: * PO amoxicillin clavulanate 45 to 90 mg/kg/day divided q12h * PO clindamycin 13 mg/kg/dose * PO linezolid 600 mg q12h (Cohort 1) or 10 mg/kg q8h | Drug | IV Ceftriaxone and Vancomycin |
Primary outcome
Evaluate the safety and tolerability of ceftaroline versus ceftriaxone plus vancomycin in pediatric subjects ages 2 months to < 18 years with complicated community-acquired bacterial pneumonia (CABP)
Time frame: between 1 and 57 days
Evaluate the safety and tolerability of IV administered ceftaroline fosamil in children with complicated CABP. Summaries of patient AEs, SAEs, deaths, discontinuations due to AEs, laboratory evaluations (hematology studies, comprehensive and metabolic panel), and vital signs will be provided for each treatment group.
2 secondary outcomes
To evaluate the efficacy of ceftaroline versus ceftriaxone plus vancomycin in pediatric subjects with complicated CABP at high risk of infection due to methicillin-resistant Staphylococcus aureus (MRSA).
Time frame: between 4 and 57 days
Evaluate the pharmacokinetics of ceftaroline in pediatric subjects with complicated CABP at high risk of infection due to methicillin-resistant Staphylococcus aureus (MRSA)
Time frame: between 4 and 57 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 2 Nov 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.
21 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ceftaroline fosamil and IV Ceftriaxone and Vancomycin in people with Infections and Pneumonia, run by Forest Laboratories at 21 sites in 4 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 2 inclusion and 4 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 2 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Ukraine, Georgia, Argentina. 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?
Evaluate the safety and tolerability of ceftaroline versus ceftriaxone plus vancomycin in pediatric subjects ages 2 months to < 18 years with complicated community-acquired bacterial pneumonia (CABP) (time frame: between 1 and 57 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 2 Nov 2015.