InfectionsPhase 2/3NCT01530763
Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Community Acquired Bacterial Pneumonia (CABP)
A Phase 2/3 study testing Ceftaroline fosamil, Ceftriaxone and amoxicillin clavulanate in people with Infections and Community Acquired Pneumonia, run by Forest Laboratories at 44 sites in 9 countries.
Trial summary
This is a study of safety and effectiveness of ceftaroline fosamil in children with Community Acquired Bacterial 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, Community Acquired Pneumonia
- What is being tested?
- Ceftaroline fosamil, Ceftriaxone and amoxicillin clavulanate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 44 sitesin 9 countries
- Study dates
- Sep 2012to 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male or female, 2 months to < 18 years old.
- Presence of CABP requiring hospitalization and IV antibacterial therapy
Who cannot join
- Documented history of any hypersensitivity of allergic reaction to any β-lactam antimicrobial.
- Confirmed or suspected infection with a pathogen known to be resistant to ceftriaxone.
- Confirmed or suspected respiratory tract infection attributed to sources other than CABP pathogens.
- Non-infectious causes of pulmonary infiltrates.
Trial locations and contacts
44 sites in 9 countries.
44 sites in 9 countries
United States13 sites
Investigational Site
Boston, Massachusetts
Investigational Site
Cleveland, Ohio
Investigational Site
Houston, Texas
Investigational Site
Long Beach, California
Investigational Site
Memphis, Tennessee
Investigational Site
Morgantown, West Virginia
Investigational Site
Oakland, California
Investigational Site
Orange, California
Investigational Site
Pittsuburg, Pennsylvania
Investigational Site
Salt Lake City, Utah
Investigational Site
San Diego, California
Investigational Site
Syracuse, New York
Investigational Site
Toledo, Ohio
Hungary8 sites
Investigational Site
Ajka
Investigational Site
Budapest
Investigational Site
Gyula, Bekes County
Investigational Site
Nagykanisza
Investigational Site
Nyíregyháza
Investigational Site
Szeged
Investigational Site
Veszprém
Investigational Site
Zalaegerszeg
Ukraine5 sites
Investigational Site
Donetsk
Investigational Site
Ivano-Frankivsk
Investigational Site
Kryvyi Rih
Investigational Site
Kyiv
Investigational Site
Zaporizhia
Bulgaria4 sites
Investigational Site
Plovdiv
Investigational Site
Rousse
Investigational Site2
Sofia
Investigational Site
Sofia
Greece4 sites
Investigational Site
Athens, Attica
Investigational Site
Heraklion, Crete
Investigational Site
Larissa, Thessaly
Investigational Site
Thessaloniki, Macedonia
Georgia3 sites
Investigational Site2
Tbilisi
Investigational Site3
Tbilisi
Investigational Site
Tbilisi
Poland3 sites
Investigational Site
Lublin
Investigational Site
Rzeszów
Investigational Site
Warsaw
Argentina2 sites
Investigational Site
Capital Federal, Buenos Aires
Investigational Site
Córdoba, Córdoba Province
About this study
Official title: A Multicenter, Randomized, Observer-Blinded, Active-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Ceftaroline Versus Ceftriaxone in Pediatric Subjects With Community-acquired Bacterial Pneumonia Requiring Hospitalization
This is a study of safety and effectiveness of ceftaroline fosamil in children with Community Acquired Bacterial Pneumonia 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 Community Acquired Bacterial Pneumonia (CABP)
- Conditions
- Infections, Community Acquired Pneumonia
- Being tested
- Ceftaroline fosamil, Ceftriaxone, amoxicillin clavulanate
- Keywords
- Infections, Pediatrics, Teflaro, cephalosporin
- Medical subject headings
- Infections, Community-Acquired 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
Treatment Group 1:
Drug: Ceftaroline fosamil Children ≥ 6 months: IV ceftaroline fosamil 12 mg/kg for subjects weighing ≤ 33 kg or 400 mg for subjects weighing > 33 kg will be infused over 60 (± 10) minutes every 8 hours (q8h) (± 1 hour)
Children < 6 months: Ceftaroline fosamil 8 mg/kg over 60 (± 10) minutes q8h (± 1 hour)
CeftriaxoneDrug
Treatment group 2:
75 mg/kg/day up to 4 g/day IV in equally divided doses, each infused over 30 (± 10) minutes q12hr (± 2 hours)
amoxicillin clavulanateDrug
Oral Switch for Treatment Groups 1 and 2:
PO amoxicillin clavulanate 90 mg/kg/day divided q12h in subjects with infections due to susceptible organisms on or after Study Day 4 (a minimum of 7 IV doses required if randomized to ceftaroline.)
| Study group | Role | What they receive |
|---|---|---|
| Ceftaroline fosamil | Experimental | Not described Receives: Drug: Ceftaroline fosamil; Drug: amoxicillin clavulanate |
| Ceftriaxone | Active comparator | Not described Receives: Drug: Ceftriaxone; Drug: amoxicillin clavulanate |
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 in pediatric subjects age 2 months to <18 years with CABP requiring hospitalization
Evaluate the safety and tolerability of IV administered ceftaroline fosamil in children with CABP. Summaries of AEs, SAEs, deaths, laboratory evaluations (hematology studies, comprehensive and metabolic panel), vital signs.
Measured: Between 1 and 50 days.
Secondary outcomes (2)
Evaluate the efficacy of ceftaroline versus ceftriaxone in pediatric subjects ages 2 months to under 18 years with CABP.
- Clinical response by subject and by baseline pathogen at Study Day 4 in the Modified Intent-to-Treat (MITT) and Microbiological modified Intent-to Treat (mMITT) Populations
- Clinical stability by subject and by baseline pathogen at Study Day 4 in the MITT and mMITT Populations
- Clinical outcome at EOIV, EOT, and TOC in the MITT and Clinically Evaluable (CE) Populations
- Clinical and microbiological outcomes by subject and by pathogen at TOC in the mMITT and Microbiologically Evaluable (ME) Populations
- Clinical relapse at LFU in the MITT Population
- Emergent infections in the mMITT Population
Measured: Between 4 and 50 days
To evaluate the pharmacokinetics of ceftaroline in pediatric subjects ages 2 months to under 18 years.
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 50 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2012 (estimated)
- Study startSep 2012
- Primary completionApr 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 161 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
- NCT01530763
- Sponsor's protocol ID
- P903-31
- Status last verified
- Jan 2015
- First submitted
- 8 Feb 2012
- Last updated
- 13 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cannavino CR, Nemeth A, Korczowski B, Bradley JS, O'Neal T, Jandourek A, Friedland HD, Kaplan SL. A Randomized, Prospective Study of Pediatric Patients With Community-acquired Pneumonia Treated With Ceftaroline Versus Ceftriaxone. Pediatr Infect Dis J. 2016 Jul;35(7):752-9. doi: 10.1097/INF.0000000000001159.
PubMed 27093162
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 Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Ceftaroline Versus Ceftriaxone in Pediatric Subjects With Community-acquired Bacterial Pneumonia Requiring Hospitalization
- ClinicalTrials.gov ID
- NCT01530763
- Acronym / sponsor ID
- P903-31
- Conditions
- Infections, Community Acquired Pneumonia
- Keywords
- Infections, Pediatrics, Teflaro, cephalosporin
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Forest LaboratoriesIndustry (pharma, biotech, devices)
- Collaborators
- AstraZeneca
- Study start
- Sep 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 10 Feb 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 Community Acquired Bacterial Pneumonia 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 Community Acquired Bacterial Pneumonia (CABP)
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, Drug: amoxicillin clavulanate |
| Ceftriaxone | Active comparator | Drug: Ceftriaxone, Drug: amoxicillin clavulanate |
Who may qualify
- Ages
- 2 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Male or female, 2 months to < 18 years old.
- Presence of CABP requiring hospitalization and IV antibacterial therapy
Key exclusion criteria (4 listed)
- Documented history of any hypersensitivity of allergic reaction to any β-lactam antimicrobial.
- Confirmed or suspected infection with a pathogen known to be resistant to ceftriaxone.
- Confirmed or suspected respiratory tract infection attributed to sources other than CABP pathogens.
- 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, TAK599Treatment Group 1: Drug: Ceftaroline fosamil Children ≥ 6 months: IV ceftaroline fosamil 12 mg/kg for subjects weighing ≤ 33 kg or 400 mg for subjects weighing > 33 kg will be infused over 60 (± 10) minutes every 8 hours (q8h) (± 1 hour) Children < 6 months: Ceftaroline fosamil 8 mg/kg over 60 (± 10) minutes q8h (± 1 hour) | Drug | Ceftaroline fosamil |
| CeftriaxoneTreatment group 2: 75 mg/kg/day up to 4 g/day IV in equally divided doses, each infused over 30 (± 10) minutes q12hr (± 2 hours) | Drug | Ceftriaxone |
| amoxicillin clavulanateOral Switch for Treatment Groups 1 and 2: PO amoxicillin clavulanate 90 mg/kg/day divided q12h in subjects with infections due to susceptible organisms on or after Study Day 4 (a minimum of 7 IV doses required if randomized to ceftaroline.) | Drug | Ceftaroline fosamil, Ceftriaxone |
Primary outcome
Evaluate the safety and tolerability of ceftaroline versus ceftriaxone in pediatric subjects age 2 months to <18 years with CABP requiring hospitalization
Time frame: Between 1 and 50 days.
Evaluate the safety and tolerability of IV administered ceftaroline fosamil in children with CABP. Summaries of AEs, SAEs, deaths, laboratory evaluations (hematology studies, comprehensive and metabolic panel), vital signs.
2 secondary outcomes
Evaluate the efficacy of ceftaroline versus ceftriaxone in pediatric subjects ages 2 months to under 18 years with CABP.
Time frame: Between 4 and 50 days
To evaluate the pharmacokinetics of ceftaroline in pediatric subjects ages 2 months to under 18 years.
Time frame: Between 4 and 50 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.
- Derived from this study: PubMed 27093162Cannavino CR, Nemeth A, Korczowski B, Bradley JS, O'Neal T, Jandourek A, Friedland HD, Kaplan SL. A Randomized, Prospective Study of Pediatric Patients With Community-acquired Pneumonia Treated With Ceftaroline Versus Ceftriaxone. Pediatr Infect Dis J. 2016 Jul;35(7):752-9. doi: 10.1097/INF.0000000000001159.
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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.
44 sites in 9 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, Ceftriaxone and amoxicillin clavulanate in people with Infections and Community Acquired Pneumonia, run by Forest Laboratories at 44 sites in 9 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 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 44 sites in United States, Hungary, Ukraine, Bulgaria, Greece and 4 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 ceftriaxone in pediatric subjects age 2 months to <18 years with CABP requiring hospitalization (time frame: Between 1 and 50 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01530763, which also lists 1 linked publication.
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.