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

Staphylococcus Aureus Bacteremia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01701219
• Other study ID #: CPT-MD-32
• Status: Completed
• Phase: Phase 4
• First received: October 3, 2012
• Last updated: July 30, 2014
• Start date: January 2013
• Est. completion date: July 2014

Study information

• Verified date: July 2014
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: July 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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).

2. Male or female = 18 years of age.

3. 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.

4. Expectation of survival for at least 2 months.

Exclusion Criteria:

1. 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.

2. 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.

3. Previous episode of S. aureus bacteremia within 3 months.

4. Known left-sided endocarditis or prosthetic heart valve.

5. Osteomyelitis or prosthetic joint infection except new onset nonhardware-associated vertebral osteomyelitis.

6. History of any hypersensitivity or allergic reaction to any ß-lactam antibacterial agent.

7. Evidence of significant hepatic, hematologic, or immunologic impairment.

8. Pregnant or nursing females.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bacteremia
• Methicillin-resistant Staphylococcus Aureus (MRSA) Bacteremia
• Staphylococcal Infections
• Staphylococcus Aureus Bacteremia

Intervention

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

Locations

Country	Name	City	State
United States	Investigational Site	Annandale	Virginia
United States	Investigational Site	Birmingham	Alabama
United States	Investigational Site	Boston	Massachusetts
United States	Investigational Site	Chicago	Illinois
United States	Investigational Site	Decatur	Georgia
United States	Investigational Site	Detroit	Michigan
United States	Investigational Site	Detroit	Michigan
United States	Investigational Site	Fort Wayne	Indiana
United States	Investigational Site	Greenville	South Carolina
United States	Investigational Site	Grosse Pointe Woods	Michigan
United States	Investigational Site	Hartford	Connecticut
United States	Investigational Site	Houston	Texas
United States	Investigational Site	Jamaica	New York
United States	Investigational Site	Laconia	New Hampshire
United States	Investigational Site	Louisville	Kentucky
United States	Investigational Site	Macon	Georgia
United States	Investigational Site	Neptune	New Jersey
United States	Investigational Site	Newark	New Jersey
United States	Investigational Site	Pensacola	Florida
United States	Investigational Site	Roanoke	Virginia
United States	Investigational Site	Royal Oak	Michigan
United States	Investigational Site	Sacramento	California
United States	Investigational Site	San Francisco	California
United States	Investigational Site	Stuart	Florida
United States	Investigational Site	Sylmar	California
United States	Investigational Site	Toledo	Ohio
United States	Investigational Site	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	60 days following completion of antibacterial therapy and discharge from the hospital, anticipated between 74 to 119 days	No
Secondary	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	Between 3 and 119 days	Yes

External Links

•   Sponsor Website