Trial record 2 of 49 for:
Open Studies | MRSA
Safety and Efficacy Study of Ceftaroline in Subjects With Staphylococcus Aureus Bacteremia or With Persistent Methicillin-Resistant Staphylococcus Aureus Bacteremia
This study is currently recruiting participants.
Verified May 2013 by Cerexa, Inc.
Sponsor:
Cerexa, Inc.
Information provided by (Responsible Party):
Cerexa, Inc.
ClinicalTrials.gov Identifier:
NCT01701219
First received: October 3, 2012
Last updated: May 9, 2013
Last verified: May 2013
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Purpose
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 or daptomycin treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Staphylococcus Aureus Bacteremia Methicillin-resistant Staphylococcus Aureus (MRSA) Bacteremia |
Drug: Ceftaroline fosamil |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Cerexa, Inc.:
Primary Outcome Measures:
- 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 or daptomycin treatment [ Time Frame: Between 3 and 119 days ] [ Designated as safety issue: Yes ]
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
Secondary Outcome Measures:
- 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 or daptomycin treatment [ Time Frame: 60 days following completion of antibacterial therapy and discharge from the hospital, anticipated between 74 to 119 days ] [ Designated as safety issue: No ]
Efficacy outcome measures:
- Time to clearance of bacteremia
- Time to defervescence
- Clinical outcome
- Mortality
- Readmission
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Cohort A
S. aureus on at least 1 blood culture within 72 hours of beginning study drug
|
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)
Other Names:
|
|
Cohort B
MRSA on a baseline blood culture and on at least 1 additional blood culture after at least 72 hours of vancomycin or daptomycin treatment
|
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)
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
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 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.
Exclusion Criteria:
- 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 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01701219
Contacts
| Contact: Cerexa Trial Coordinator | 510-285-9200 | clinicaltrials@cerexa.com |
Locations
| United States, California | |
| Investigational Site | Recruiting |
| Sylmar, California, United States, 91342 | |
| Investigational Site | Recruiting |
| Torrance, California, United States, 90502 | |
| United States, Connecticut | |
| Investigational Site | Recruiting |
| Hartford, Connecticut, United States, 06102 | |
| United States, Georgia | |
| Investigational Site | Recruiting |
| Decatur, Georgia, United States, 30030 | |
| United States, Indiana | |
| Investigational Site | Recruiting |
| Fort Wayne, Indiana, United States, 46845 | |
| United States, Michigan | |
| Investigational Site | Recruiting |
| Detroit, Michigan, United States, 48202 | |
| Investigational Site | Recruiting |
| Grosse Pointe Woods, Michigan, United States, 48236 | |
| Investigational Site | Recruiting |
| Royal Oak, Michigan, United States, 48073 | |
| United States, New Jersey | |
| Investigational Site | Recruiting |
| Newark, New Jersey, United States, 07102 | |
| United States, South Carolina | |
| Investigational Site | Recruiting |
| Greenville, South Carolina, United States, 29605 | |
| United States, Virginia | |
| Investigational Site | Recruiting |
| Roanoke, Virginia, United States, 24014 | |
Sponsors and Collaborators
Cerexa, Inc.
More Information
Additional Information:
No publications provided
| Responsible Party: | Cerexa, Inc. |
| ClinicalTrials.gov Identifier: | NCT01701219 History of Changes |
| Other Study ID Numbers: | CPT-MD-32 |
| Study First Received: | October 3, 2012 |
| Last Updated: | May 9, 2013 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Cerexa, Inc.:
|
Staphylococcus aureus bacteremia Methicillin-resistant Staphylococcus aureus bacteremia MRSA bacteremia Blood |
Adult Infections Blood Culture |
Additional relevant MeSH terms:
|
Bacteremia Staphylococcal Infections Bacterial Infections Sepsis Infection Systemic Inflammatory Response Syndrome Inflammation |
Pathologic Processes Gram-Positive Bacterial Infections Methicillin Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013