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

Phase 4

Completed

• Conditions: Methicillin-resistant Staphylococcus Aureus (MRSA) Bacteremia; Staphylococcus Aureus Bacteremia
• Interventions: Drug: Ceftaroline fosamil

• Registration Number: NCT01701219
• Lead Sponsor: Forest Laboratories

Brief 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.

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.

Study Timeline

• Study First Submitted: 2012-10-03
• Study First Submitted QC: 2012-10-03
• Study First Posted: 2012-10-05
• Study Start: 2013-01
• Primary Completion: 2014-05
• Status Verified: 2014-07
• Study Completion: 2014-07
• Last Update Submitted: 2014-07-30
• Last Update Posted: 2014-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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 β-lactam antibacterial agent.
7. Evidence of significant hepatic, hematologic, or immunologic impairment.
8. Pregnant or nursing females.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort A	Ceftaroline fosamil	S. aureus on at least 1 blood culture within 72 hours of beginning study drug
Cohort B	Ceftaroline fosamil	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

Primary Outcome Measures

Name	Time	Method
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	60 days following completion of antibacterial therapy and discharge from the hospital, anticipated between 74 to 119 days	Efficacy outcome measures: * Time to clearance of bacteremia; * Time to defervescence; * Clinical outcome; * Mortality; * Readmission

Secondary Outcome Measures

Name	Time	Method
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	Between 3 and 119 days	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

Trial Locations

Locations (1)

Investigational Site; 🇺🇸 Roanoke, Virginia, United States