AzTrials
AzTrials

Staphylococcus Aureus BacteremiaPhase 4NCT01701219

Safety and Efficacy Study of Ceftaroline in Subjects With Staphylococcus Aureus Bacteremia or With Persistent Methicillin-Resistant Staphylococcus Aureus Bacteremia

A Phase 4 study testing Ceftaroline fosamil in people with Staphylococcus Aureus Bacteremia and Methicillin-resistant Staphylococcus Aureus (MRSA) Bacteremia, run by Forest Laboratories at 27 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a study of safety and efficacy of ceftaroline fosamil in Subjects with Staphylococcus aureus Bacteremia or with Methicillin-Resistant Staphylococcus aureus (MRSA) Bacteremia persisting after at least 72 hours of vancomycin and/or daptomycin treatment. Read more about this study

Who is it for?
Ages 18 years and older
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
56 participants
Where
27 sitesUnited States
Study dates
Jan 2013to Jul 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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Presence of bacteremia due solely to:
  • S. aureus on at least 1 blood culture within 72 hours of beginning study drug (Cohort A) OR
  • MRSA on a baseline blood culture and on at least 1 additional blood culture after at least 72 hours of vancomycin and/or daptomycin treatment (Cohort B).
  • Male or female ≥ 18 years of age.
  • If female of childbearing potential must be willing to practice sexual abstinence or dual methods of contraception during treatment and for at least 30 days after the last dose of study drug.
  • Expectation of survival for at least 2 months.

Who cannot join

  • For subjects in Cohort A: previous therapy for more than 48 hours with any parenteral antibiotic with activity against S. aureus within 72 hours of positive blood culture results.
  • For subjects in Cohort B: previous therapy for more than 48 hours with any parenteral antibiotic with activity against MRSA, except vancomycin and/or daptomycin, within 72 hours of positive blood culture results confirming persistence.
  • Previous episode of S. aureus bacteremia within 3 months.
  • Known left-sided endocarditis or prosthetic heart valve.
  • Osteomyelitis or prosthetic joint infection except new onset nonhardware-associated vertebral osteomyelitis.
  • History of any hypersensitivity or allergic reaction to any β-lactam antibacterial agent.
  • Evidence of significant hepatic, hematologic, or immunologic impairment.
  • Pregnant or nursing females.

Trial locations and contacts

27 sites in 1 country.

27 sites in 1 country

United States27 sites

  • Investigational Site

    Annandale, Virginia, 22003

  • Investigational Site

    Birmingham, Alabama, 35294

  • Investigational Site

    Boston, Massachusetts, 02111

  • Investigational Site

    Chicago, Illinois, 60612

  • Investigational Site

    Decatur, Georgia, 30030

  • Investigational Site

    Detroit, Michigan, 48201

  • Investigational Site

    Detroit, Michigan, 48202

  • Investigational Site

    Fort Wayne, Indiana, 46845

  • Investigational Site

    Greenville, South Carolina, 29605

  • Investigational Site

    Grosse Pointe Woods, Michigan, 48236

  • Investigational Site

    Hartford, Connecticut, 06102

  • Investigational Site

    Houston, Texas, 77030

  • Investigational Site

    Jamaica, New York, 11418

  • Investigational Site

    Laconia, New Hampshire, 03246

  • Investigational Site

    Louisville, Kentucky, 40202

  • Investigational Site

    Macon, Georgia, 31201

  • Investigational Site

    Neptune City, New Jersey, 07753

  • Investigational Site

    Newark, New Jersey, 07102

  • Investigational Site

    Pensacola, Florida, 32504

  • Investigational Site

    Roanoke, Virginia, 24014

  • Investigational Site

    Royal Oak, Michigan, 48073

  • Investigational Site

    Sacramento, California, 95817

  • Investigational Site

    San Francisco, California, 94110

  • Investigational Site

    Stuart, Florida, 34994

  • Investigational Site

    Sylmar, California, 91342

  • Investigational Site

    Toledo, Ohio, 43620

  • Investigational Site

    Torrance, California, 90502

Other trials in United States

About this study

Official title: A Multicenter, 2-Cohort Study to Describe the Safety and Efficacy of Ceftaroline Fosamil in Subjects With Staphylococcus Aureus Bacteremia or With Persistent Methicillin-Resistant Staphylococcus Aureus Bacteremia

This is a study of safety and efficacy of ceftaroline fosamil in Subjects with Staphylococcus aureus Bacteremia or with Methicillin-Resistant Staphylococcus aureus (MRSA) Bacteremia persisting after at least 72 hours of vancomycin and/or daptomycin treatment.

Read the detailed description

Subjects with either S. aureus bacteremia or persistent MRSA bacteremia will be treated with open label ceftaroline fosamil, safety will be monitored and clearance of bacteremia will be evaluated.

Being tested
Ceftaroline fosamil
Keywords
Staphylococcus aureus bacteremia, Methicillin-resistant Staphylococcus aureus bacteremia, MRSA bacteremia, Blood, Adult, Infections, Blood Culture
Medical subject headings
Bacteremia, 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

    Ceftaroline fosamil 600 mg intravenous (IV) infused over 60 (± 10) minutes every 8 hours (q8h) (± 1 hour) (dosing may be adjusted for renal function)

Study groups in NCT01701219
Study groupRoleWhat they receive
Cohort AOtherS. aureus on at least 1 blood culture within 72 hours of beginning study drug
Receives: Drug: Ceftaroline fosamil
Cohort BOtherMRSA on a baseline blood culture and on at least 1 additional blood culture after at least 72 hours of vancomycin and/or daptomycin treatment
Receives: Drug: Ceftaroline fosamil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate the safety of ceftaroline fosamil in adult Subjects (≥ 18 years of age) with Staphylococcus aureus Bacteremia or with MRSA Bacteremia persisting after at least 72 hours of vancomycin and/or daptomycin treatment

    Efficacy outcome measures:

    • Time to clearance of bacteremia
    • Time to defervescence
    • Clinical outcome
    • Mortality
    • Readmission

    Measured: 60 days following completion of antibacterial therapy and discharge from the hospital, anticipated between 74 to 119 days

Secondary outcomes (1)

  1. Evaluate the efficacy of ceftaroline fosamil in adult Subjects (≥ 18 years of age) with Staphylococcus aureus Bacteremia or with MRSA Bacteremia persisting after at least 72 hours of vancomycin and/or daptomycin treatment

    Safety evaluations will be conducted and assessments will include:

    • Adverse events including deaths will be evaluated
    • Laboratory: complete blood count (CBC) with differential and chemistry panel

    Measured: Between 3 and 119 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2012 (estimated)
  2. Study startJan 2013
  3. Primary completionMay 2014
  4. Study completionJul 2014

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01701219
Sponsor's protocol ID
CPT-MD-32
Status last verified
Jul 2014
First submitted
3 Oct 2012
Last updated
31 Jul 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ceftaroline fosamil in people with Staphylococcus Aureus Bacteremia and Methicillin-resistant Staphylococcus Aureus (MRSA) Bacteremia, run by Forest Laboratories at 27 sites in United States.

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 6 inclusion and 8 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 31 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States. 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 of ceftaroline fosamil in adult Subjects (≥ 18 years of age) with Staphylococcus aureus Bacteremia or with MRSA Bacteremia persisting after at least 72 hours of vancomycin and/or daptomycin treatment (time frame: 60 days following completion of antibacterial therapy and discharge from the hospital, anticipated between 74 to 119 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 NCT01701219.

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 31 Jul 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in