Community-Acquired Bacterial Pneumonia (CABP)Phase 4NCT01666743
Safety and Efficacy Study of Ceftaroline in Elderly Subjects With Community-Acquired Bacterial Pneumonia
A Phase 4 study testing Ceftaroline fosamil in people with Community-Acquired Bacterial Pneumonia (CABP), run by Forest Laboratories.
Trial summary
The purpose of this study is to determine the safety and efficacy of ceftaroline fosamil in elderly subjects with community-acquired bacterial pneumonia (CABP) receiving antibiotic therapy in the hospital. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Community-Acquired Bacterial Pneumonia (CABP)
- What is being tested?
- Ceftaroline fosamil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2012to Mar 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Male or female ≥ 65 years of age.
- Presence of CABP warranting hospitalization.
- Acute illness with ≥ 2 clinical signs or symptoms of lower respiratory tract infection.
- Radiographically confirmed pneumonia.
Who cannot join
- History of any hypersensitivity or allergic reaction to any β-lactam or macrolide antibacterial agent.
- Confirmed or suspected respiratory tract infection due solely to an atypical bacterial, mycobacterial, viral, or fungal pathogen.
- More than 24 hours of potentially effective antibacterial therapy within 96 hours prior to enrollment.
- Life expectancy of < 30 days or presence of an order of Do Not Resuscitate (DNR).
- Evidence of significant hematologic, hepatic, or immunologic impairment.
About this study
Official title: A Multicenter Study to Describe the Safety and Efficacy of Ceftaroline Fosamil in Elderly Subjects With Community-Acquired Bacterial Pneumonia
The purpose of this study is to determine the safety and efficacy of ceftaroline fosamil in elderly subjects with community-acquired bacterial pneumonia (CABP) receiving antibiotic therapy in the hospital.
Read the detailed description
This is a multicenter study of ceftaroline fosamil in elderly subjects (≥ 65 years of age) with CABP. Adjunctive macrolide therapy is to be used at the Investigator's discretion. A switch to oral treatment may be allowed at the discretion of the Investigator. The total duration of therapy is 5 to 7 days; a minimum of 48 hours of study drug is required.
- Being tested
- Ceftaroline fosamil
- Keywords
- Community-Acquired Pneumonia, Lung, Adult, Infections
- Medical subject headings
- Community-Acquired Pneumonia, 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
IV ceftaroline fosamil 600 mg infused over 60 (± 10) minutes every 12 hours (dosing may be adjusted for renal impairment)
| Study group | Role | What they receive |
|---|---|---|
| Ceftaroline fosamil | Experimental | IV ceftaroline fosamil 600 mg infused over 60 (± 10) minutes every 12 hours (dosing may be adjusted for renal impairment) Receives: Drug: Ceftaroline fosamil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety of ceftaroline fosamil in elderly subjects (≥ 65 years) with community-acquired bacterial pneumonia (CABP)
Safety evaluations will be conducted and assessments will include:
- Adverse events including deaths will be evaluated.
- Laboratory: complete blood count with differential, and chemistry panel.
Measured: Between 3 and 33-37 days
Secondary outcomes (1)
Evaluate the efficacy of ceftaroline fosamil in elderly subjects (≥ 65 years) with community-acquired bacterial pneumonia (CABP)
Efficacy outcome measures:
- Time to clinical stability
- Length of stay
- Clinical outcome at End-of-Intravenous Study Drug, End-of-Therapy, and Test-of-Cure
- Mortality
- 30-day readmission
Measured: 30 days following discharge from the hospital, anticipated between 33 to 37 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2012 (estimated)
- Study startNov 2012
- Primary completionSep 2013 (estimated)
- Study completionMar 2014 (estimated)
Why it stopped: Change in strategy.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community-Acquired Bacterial Pneumonia (CABP)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 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
- NCT01666743
- Sponsor's protocol ID
- CPT-MD-34
- Status last verified
- Feb 2013
- First submitted
- 14 Aug 2012
- Last updated
- 11 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study to Describe the Safety and Efficacy of Ceftaroline Fosamil in Elderly Subjects With Community-Acquired Bacterial Pneumonia
- ClinicalTrials.gov ID
- NCT01666743
- Acronym / sponsor ID
- CPT-MD-34
- Keywords
- Community-Acquired Pneumonia, Lung, Adult, Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change in strategy.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Forest LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 16 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.
The purpose of this study is to determine the safety and efficacy of ceftaroline fosamil in elderly subjects with community-acquired bacterial pneumonia (CABP) receiving antibiotic therapy in the hospital.
Detailed description
This is a multicenter study of ceftaroline fosamil in elderly subjects (≥ 65 years of age) with CABP. Adjunctive macrolide therapy is to be used at the Investigator's discretion. A switch to oral treatment may be allowed at the discretion of the Investigator. The total duration of therapy is 5 to 7 days; a minimum of 48 hours of study drug is required.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ceftaroline fosamil | Experimental | Drug: Ceftaroline fosamilIV ceftaroline fosamil 600 mg infused over 60 (± 10) minutes every 12 hours (dosing may be adjusted for renal impairment) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Male or female ≥ 65 years of age.
- Presence of CABP warranting hospitalization.
- Acute illness with ≥ 2 clinical signs or symptoms of lower respiratory tract infection.
- Radiographically confirmed pneumonia.
Key exclusion criteria (5 listed)
- History of any hypersensitivity or allergic reaction to any β-lactam or macrolide antibacterial agent.
- Confirmed or suspected respiratory tract infection due solely to an atypical bacterial, mycobacterial, viral, or fungal pathogen.
- More than 24 hours of potentially effective antibacterial therapy within 96 hours prior to enrollment.
- Life expectancy of < 30 days or presence of an order of Do Not Resuscitate (DNR).
- Evidence of significant hematologic, hepatic, or immunologic impairment.
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, TAK599IV ceftaroline fosamil 600 mg infused over 60 (± 10) minutes every 12 hours (dosing may be adjusted for renal impairment) | Drug | Ceftaroline fosamil |
Primary outcome
Evaluate the safety of ceftaroline fosamil in elderly subjects (≥ 65 years) with community-acquired bacterial pneumonia (CABP)
Time frame: Between 3 and 33-37 days
Safety evaluations will be conducted and assessments will include: * Adverse events including deaths will be evaluated. * Laboratory: complete blood count with differential, and chemistry panel.
1 secondary outcome
Evaluate the efficacy of ceftaroline fosamil in elderly subjects (≥ 65 years) with community-acquired bacterial pneumonia (CABP)
Time frame: 30 days following discharge from the hospital, anticipated between 33 to 37 days.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2013.
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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ceftaroline fosamil in people with Community-Acquired Bacterial Pneumonia (CABP), run by Forest Laboratories.
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 4 inclusion and 5 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: withdrawn, as of the sponsor's last update on 11 Feb 2013. 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 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 was withdrawn before enrolling participants, so there are no results.
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 of ceftaroline fosamil in elderly subjects (≥ 65 years) with community-acquired bacterial pneumonia (CABP) (time frame: Between 3 and 33-37 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 11 Feb 2013.