InfectionsPhase 4NCT01645735
Evaluation of Ceftaroline Fosamil Versus a Comparator in Adult Subjects With Community-acquired Bacterial Pneumonia (CABP) With Risk for Methicillin-resistant Staphylococcus Aureus
A Phase 4 study testing Ceftaroline fosamil and Ceftriaxone plus vancomycin in people with Infections, run by Forest Laboratories at 31 sites in 8 countries.
Trial summary
The purpose of this study is to determine whether ceftaroline is effective and safe for the treatment of patients with Community-acquired Bacterial Pneumonia (CABP) at risk for infection due to Methicillin-resistant Staphylococcus aureus (MRSA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infections
- What is being tested?
- Ceftaroline fosamil and Ceftriaxone plus vancomycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 31 sitesin 8 countries
- Study dates
- Oct 2012to Dec 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects are required to meet All of the following inclusion criteria:
- Male or female, ≥ 18 years old
- Presence of CABP requiring hospitalization
- Presence of CABP meeting the following criteria:
- confirmed pneumonia (new or progressive pulmonary) II. Acute illness (≤ 7 days' duration) with at least 3 clinical signs or symptoms consistent with a lower respiratory tract infection
- MRSA Risk Factors
- MRSA-positive blood culture or respiratory specimen or a risk factor for MRSA such as a history of colonization with MRSA
Who cannot join
- Subjects must Not meet any of the following exclusion criteria at baseline:
- History of any hypersensitivity or allergic reaction to any β-lactam antimicrobial
- Suspected or microbiologically-documented infection with a pathogen known to be resistant to any of the study drugs
- Non-infectious causes of pulmonary infiltrates (eg, pulmonary embolism, chemical pneumonitis from aspiration, hypersensitivity pneumonia, congestive heart failure)
- More than 24 hours of potentially effective systemic antibacterial therapy for CABP within 96 hours before randomization
- End-stage renal disease [Creatinine Clearance (CrCl) < 15], including hemodialysis
- Evidence of significant hepatic, hematological, or immunocompromising condition
Trial locations and contacts
31 sites in 8 countries.
31 sites in 8 countries
United States13 sites
Investigational Site
Chicago, Illinois, 60611
Investigational Site
Columbus, Ohio, 43215
Investigational Site
DeLand, Florida, 32720
Investigational Site
Kansas City, Kansas, 66012
Investigational Site
Laconia, New Hampshire, 03246
Investigational Site
Lima, Ohio, 45801
Investigational Site
Minneapolis, Minnesota, 55145
Investigational Site
Oklahoma City, Oklahoma, 73104
Investigational Site
Omaha, Nebraska, 68131
Investigational Site
Phoenix, Arizona, 85008
Investigational Site
Royal Oak, Michigan, 48073
Investigational Site
St Louis, Missouri, 63110
Investigational Site
Sylmar, California, 91342
Ukraine5 sites
Investigational Site
Dnipropetrovsk, 49059
Investigational Site
Ivano-Frankivsik, 76018
Investigational Site
Kharkiv, 61115
Investigational Site
Kyiv, 03680
Investigational Site
Zaporizhzhya, 69035
Poland3 sites
Investigational Site
Lodz, 90-153
Investigational Site
Lublin, 20-954
Investigational Site
Wilkowice-Bystra, 43-365
Romania3 sites
Investigational Site
Bucharest, 030303
Investigational Site
Craiova, Dolj, 200515
Investigational Site
Iași, 700115
Russia3 sites
Investigational Site
Moscow, 109240
Investigational Site
Saint Petersburg, 196247
Investigational Site
Yaroslavl, 150003
Spain2 sites
Investigational Site
Alicante, 03010
Investigational Site
Barcelona, 08304
About this study
Official title: A Multicenter, Multinational, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Ceftaroline Fosamil Versus Ceftriaxone Plus Vancomycin in Adult Subjects With Community-acquired Bacterial Pneumonia at Risk for Infection Due to Methicillin-resistant Staphylococcus Aureus
The purpose of this study is to determine whether ceftaroline is effective and safe for the treatment of patients with Community-acquired Bacterial Pneumonia (CABP) at risk for infection due to Methicillin-resistant Staphylococcus aureus (MRSA).
Read the detailed description
A Multicenter, Multinational, Randomized, Double-blind Study to Evaluate the Efficacy and safety of Ceftaroline fosamil Versus Ceftriaxone Plus Vancomycin in Adult Subjects with Community-acquired Bacterial Pneumonia at Risk for Infection Due to Methicillin-resistant Staphylococcus aureus.
- Conditions
- Infections
- Being tested
- Ceftaroline fosamil, Ceftriaxone plus vancomycin
- Keywords
- Infections, Teflaro, cephalosporin, Ceftaroline, antibiotics, 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
Ceftaroline fosamil 600 mg IV over 60 minutes q8h; treatment duration 5 to 14 days
Ceftriaxone plus vancomycinDrug
Ceftriaxone 2g IV over 30 minutes q24h plus vancomycin 15 mg/kg IV q12h initially and then dose adjusted based on trough concentrations; treatment duration 5 to 14 days
| Study group | Role | What they receive |
|---|---|---|
| Ceftaroline | Experimental | Ceftaroline fosamil 600 mg Intravenous (IV) administration over 60 minutes, every 8 hours (q8h); dosing to be adjusted for renal function; treatment duration 5 to 14 days Receives: Drug: Ceftaroline fosamil |
| Ceftriaxone plus vancomycin | Active comparator | Ceftriaxone 2 g IV over 30 minutes once per day (q24h) plus vancomycin 15 mg/kg IV every 12 hours (q12h) initially and then dose adjusted based on trough concentrations; treatment duration 5 to 14 days Receives: Drug: Ceftriaxone plus vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Response at Study Day 4 in the Modified Intent-to-Treat (MITT) Population
Clinical response was defined as meeting all of the following criteria:
- Symptom Improvement - Improvement in at least 2 and no worsening of any of the following symptoms compared to baseline:
- Cough
- Dyspnea
- Sputum production
- Chest pain
- Clinical Stability (per Infectious Diseases Society of America/American Thoracic Society (IDSA/ATS) guidelines; Mandell et al, 2007):
- Temperature ≤ 37.8°C
- Heart rate ≤ 100 beats/min
- Respiratory rate ≤ 24 breaths/min
- Systolic blood pressure ≥ 90 mmHg
- Oxygen saturation ≥ 90%
- Confusion/disorientation absent
Measured: Study Day 4
Clinical Outcome at Test of Cure (TOC) in the MITT Population
An assessment of clinical outcome was made by the Investigator at TOC. The clinical outcome categories were:
Cure: Resolution of all acute signs and symptoms of CABP or improvement to such an extent that no further antimicrobial therapy was required
Failure: Subjects who meet either of the following criteria:
- Incomplete resolution or worsening of CABP signs and symptoms or development of new CABP signs or symptoms requiring alternative nonstudy antimicrobial therapy
- Death in which CABP is contributory
Indeterminate: Study data are not available for evaluation of efficacy for any reason, including:
- Death in which CABP is clearly noncontributory
- Lost to follow-up
- Extenuating circumstances precluding classification as a cure or failure
A favorable clinical outcome at Test-of Cure (TOC) was clinical cure.
Measured: Test of Cure, an average of 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2012 (estimated)
- Study startOct 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forest Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Forest Laboratories Inc, an affiliate of Allergan plc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01645735
- Sponsor's protocol ID
- P903-25
- Status last verified
- Dec 2015
- First submitted
- 9 Jul 2012
- Last updated
- 1 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Multinational, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Ceftaroline Fosamil Versus Ceftriaxone Plus Vancomycin in Adult Subjects With Community-acquired Bacterial Pneumonia at Risk for Infection Due to Methicillin-resistant Staphylococcus Aureus
- ClinicalTrials.gov ID
- NCT01645735
- Acronym / sponsor ID
- P903-25
- Conditions
- Infections
- Keywords
- Infections, Teflaro, cephalosporin, Ceftaroline, antibiotics, pneumonia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Forest LaboratoriesIndustry (pharma, biotech, devices)
- Collaborators
- AstraZeneca
- Study start
- Oct 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 20 Jul 2012 (estimated)
- Results
- Posted 1 Feb 2016
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 determine whether ceftaroline is effective and safe for the treatment of patients with Community-acquired Bacterial Pneumonia (CABP) at risk for infection due to Methicillin-resistant Staphylococcus aureus (MRSA).
Detailed description
A Multicenter, Multinational, Randomized, Double-blind Study to Evaluate the Efficacy and safety of Ceftaroline fosamil Versus Ceftriaxone Plus Vancomycin in Adult Subjects with Community-acquired Bacterial Pneumonia at Risk for Infection Due to Methicillin-resistant Staphylococcus aureus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ceftaroline | Experimental | Drug: Ceftaroline fosamilCeftaroline fosamil 600 mg Intravenous (IV) administration over 60 minutes, every 8 hours (q8h); dosing to be adjusted for renal function; treatment duration 5 to 14 days |
| Ceftriaxone plus vancomycin | Active comparator | Drug: Ceftriaxone plus vancomycinCeftriaxone 2 g IV over 30 minutes once per day (q24h) plus vancomycin 15 mg/kg IV every 12 hours (q12h) initially and then dose adjusted based on trough concentrations; treatment duration 5 to 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects are required to meet All of the following inclusion criteria:
- confirmed pneumonia (new or progressive pulmonary) II. Acute illness (≤ 7 days' duration) with at least 3 clinical signs or symptoms consistent with a lower respiratory tract infection
- MRSA Risk Factors
- MRSA-positive blood culture or respiratory specimen or a risk factor for MRSA such as a history of colonization with MRSA
Key exclusion criteria (7 listed)
- Subjects must Not meet any of the following exclusion criteria at baseline:
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, TAK599Ceftaroline fosamil 600 mg IV over 60 minutes q8h; treatment duration 5 to 14 days | Drug | Ceftaroline |
| Ceftriaxone plus vancomycinCeftriaxone 2g IV over 30 minutes q24h plus vancomycin 15 mg/kg IV q12h initially and then dose adjusted based on trough concentrations; treatment duration 5 to 14 days | Drug | Ceftriaxone plus vancomycin |
Primary outcome
Clinical Response at Study Day 4 in the Modified Intent-to-Treat (MITT) Population
Time frame: Study Day 4
Clinical response was defined as meeting all of the following criteria: * Symptom Improvement - Improvement in at least 2 and no worsening of any of the following symptoms compared to baseline: * Cough * Dyspnea * Sputum production * Chest pain * Clinical Stability (per Infectious Diseases Society of America/American Thoracic Society (IDSA/ATS) guidelines; Mandell et al, 2007): * Temperature ≤ 37.8°C * Heart rate ≤ 100 beats/min * Respiratory rate ≤ 24 breaths/min * Systolic blood pressure ≥ 90 mmHg * Oxygen saturation ≥ 90% * Confusion/disorientation absent
Clinical Outcome at Test of Cure (TOC) in the MITT Population
Time frame: Test of Cure, an average of 3 weeks
An assessment of clinical outcome was made by the Investigator at TOC. The clinical outcome categories were: Cure: Resolution of all acute signs and symptoms of CABP or improvement to such an extent that no further antimicrobial therapy was required Failure: Subjects who meet either of the following criteria: * Incomplete resolution or worsening of CABP signs and symptoms or development of new CABP signs or symptoms requiring alternative nonstudy antimicrobial therapy * Death in which CABP is contributory Indeterminate: Study data are not available for evaluation of efficacy for any reason, including: * Death in which CABP is clearly noncontributory * Lost to follow-up * Extenuating circumstances precluding classification as a cure or failure A favorable clinical outcome at Test-of Cure (TOC) was clinical cure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Infections
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
RecruitingObservational study
VIRal Pulmonary Infections in Older AGE
Viral Pulmonary Infections
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
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.
Medical Monitor study director
Forest Laboratories Inc, an affiliate of Allergan plc
31 sites in 8 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 Ceftriaxone plus vancomycin in people with Infections, run by Forest Laboratories at 31 sites in 8 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 7 inclusion and 7 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 1 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, Ukraine, Poland, Romania, Russia and 3 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 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?
Yes. Results are posted in the registry (first posted 1 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Clinical Response at Study Day 4 in the Modified Intent-to-Treat (MITT) Population (time frame: Study Day 4). The study lists 2 primary outcomes in all. 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 1 Feb 2016.