Back to resultsCeftaroline in the Treatment of Bone and Joint Infections
Primary Purpose
Osteomyelitis, Joint Infections
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ceftaroline
Sponsored by
About this trial
This is an interventional treatment trial for Osteomyelitis focused on measuring Osteoarticular infections, Osteomyelitis, Joint infections, MRSA (Methicillin- Resistant Staphylococcus Aureus), MSSA (Methicillin- Susceptible Staphylococcus Aureus)
Eligibility Criteria
Inclusion Criteria:
Adults > 18 years of age with the following osteoarticular infections:
Infected prosthetic knee or hip (first or second episode) with 2 stage procedure planned.
Criteria for infected joint:
- Sinus tract which communicates with the joint
- Preoperative diagnosis by diagnostic, culture positive arthrocentesis
- Intraoperative diagnosis-evidence of purulence/inflammation is seen by the surgeon and/or the pathologist, and at least 2 intraoperative samples grow the same organism (only 1 needed if S. aureus) OR
Acute osteomyelitis of an extremity Criteria for acute osteomyelitis (all 4 needed)
- Onset less than 4 weeks prior to evaluation
- Radiographic (plain, MRI, TC) evidence of osteomyelitis
- Positive culture from bone or blood culture with organism known to cause osteomyelitis
- Orthopedic consultant must concur with diagnosis. PLUS: Positive bone/joint or blood culture for an organism known to cause osteomyelitis which is Ceftaroline susceptible
Exclusion criteria:
Immunocompromised hosts:
- AIDS/HIV patients
- Cancer requiring ongoing chemotherapy or radiation therapy steroid on an ongoing basis.
- Any condition requiring > 20 mg prednisone or equivalent
- TNF (tumor necrosing factor) inhibitor use (ongoing)
- Organ transplant list
- Diabetic foot infections
- Osteomyelitis in association with decubitus ulcers
- Vertebral osteomyelitis/spinal epidural abscess
- Septic bursitis
- Gonococcal arthritis
- Ceftaroline nonsusceptible organisms isolated from bone, joint or blood.
- Infected external fixation devices
- Calculated creatinine clearance < 50 mL/min at baseline
- History of severe penicillin/B lactam allergy (ID to evaluate)
- Intravenous drug use - lifetime exclusion
- Patients with a nail puncture wound to foot
- Patients at high risk for MDR (multidrug resistant) Gram negative organisms
Please note the use of antibiotic containing cement is not exclusion, as it represents standard of care in some of the infections to be studied
Sites / Locations
- Orlando Regional Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Acute Osteomyelitis - Non MRSA
Acute osteomyelitis MRSA isolate
Prosthetic joint infection
Arm Description
For treatment of Acute osteomyelitis (< 6 months duration) Non MRSA isolate- Ceftaroline 600 MG (milligram) IV (intra-venous) every 8 hours for 6 weeks.
For treatment of Acute osteomyelitis (< 6 months duration) MRSA isolate- Ceftaroline 600 MG IV every 8 hours for 8 weeks.
For treatment of prosthetic joint infection Ceftaroline 600 mg IV every 8 hours for 6 weeks.
Outcomes
Primary Outcome Measures
Sustained clinical remission from the treated osteoarticular infection
Sustained clinical remission is defined by the absence of either clinical or microbiological evidence of failure at 1 year after study drug completion, in patients who complete the protocol's antibiotic regimen(s) and did not require subsequent antibiotics for their osteoarticular infection beyond the protocol prescribed regimen.
Secondary Outcome Measures
Initial clinical success from the treated osteoarticular infection
Initial clinical success will be measured by the agreement of the Infectious disease consultant and Orthopedic surgeon that the patient has had a positive response to therapy. Success will be measured by decrease of CRP (C reactive protein) by 50% from baseline if initially elevated, no evidence of drainage, sinus tract formation or infection related bone instability. Follow up cultures, if available are negative for originally isolated organism. In patients with prothetic joints no new warmth, tenderness or inflammation.
Full Information
NCT ID
NCT02005068
First Posted
November 21, 2013
Last Updated
August 6, 2014
Sponsor
Orlando Health, Inc.
Collaborators
Forest Laboratories
1. Study Identification
Unique Protocol Identification Number
NCT02005068
Brief Title
Ceftaroline in the Treatment of Bone and Joint Infections
Official Title
Ceftaroline in the Treatment of Bone and Joint Infections
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Withdrawn
Why Stopped
Failed to enroll any patients despite study modifications
Study Start Date
April 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Orlando Health, Inc.
Collaborators
Forest Laboratories
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a study to evaluate the efficacy of Ceftaroline in the treatment of bone and joint infections.
Detailed Description
Study evaluates the efficacy of Ceftaroline 600mg IV every 8 hours for the treatment of acute osteomyelitis and/or infected joints.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteomyelitis, Joint Infections
Keywords
Osteoarticular infections, Osteomyelitis, Joint infections, MRSA (Methicillin- Resistant Staphylococcus Aureus), MSSA (Methicillin- Susceptible Staphylococcus Aureus)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acute Osteomyelitis - Non MRSA
Arm Type
Experimental
Arm Description
For treatment of Acute osteomyelitis (< 6 months duration) Non MRSA isolate- Ceftaroline 600 MG (milligram) IV (intra-venous) every 8 hours for 6 weeks.
Arm Title
Acute osteomyelitis MRSA isolate
Arm Type
Experimental
Arm Description
For treatment of Acute osteomyelitis (< 6 months duration) MRSA isolate- Ceftaroline 600 MG IV every 8 hours for 8 weeks.
Arm Title
Prosthetic joint infection
Arm Type
Experimental
Arm Description
For treatment of prosthetic joint infection Ceftaroline 600 mg IV every 8 hours for 6 weeks.
Intervention Type
Drug
Intervention Name(s)
Ceftaroline
Other Intervention Name(s)
Teflaro, Ceftaroline fosamil, PPI-0903, TAK-599,, ceftaroline acetate, ceftaroline prodrug, ceftaroline fosamil for injection, Ceftaroline: PPI-0903M, T 91825, Chemical Name (6R,7R)-7-{(2Z)-2-(ethoxyimino)-2-[5-, (phosphonoamino)-1,2,4-thiadiazol-3-, yl]acetamino}-3-[(4-(1-methylpyridin-1-ium-4-yl)-, 1,3-thiazol-2-yl]sulfanyl}-8-oxo-5-thia-1-, azabicyclo[4.2.0]oct-2-ene-2-carboxylate
Intervention Description
The duration of treatment will vary based on type of infection (acute osteomyelitis or joint infection) and if MRSA positive or negative.
Primary Outcome Measure Information:
Title
Sustained clinical remission from the treated osteoarticular infection
Description
Sustained clinical remission is defined by the absence of either clinical or microbiological evidence of failure at 1 year after study drug completion, in patients who complete the protocol's antibiotic regimen(s) and did not require subsequent antibiotics for their osteoarticular infection beyond the protocol prescribed regimen.
Time Frame
1 year after study drug completion
Secondary Outcome Measure Information:
Title
Initial clinical success from the treated osteoarticular infection
Description
Initial clinical success will be measured by the agreement of the Infectious disease consultant and Orthopedic surgeon that the patient has had a positive response to therapy. Success will be measured by decrease of CRP (C reactive protein) by 50% from baseline if initially elevated, no evidence of drainage, sinus tract formation or infection related bone instability. Follow up cultures, if available are negative for originally isolated organism. In patients with prothetic joints no new warmth, tenderness or inflammation.
Time Frame
30 days after conclusion of study antibiotic
Other Pre-specified Outcome Measures:
Title
Number of participants with defined symptoms, signs and lab values as markers of safety and tolerance.
Description
Symptoms will be assessed daily by study team while patient is hospitalized and reviewed weekly by investigator while the patient is receiving study drug. Specific symptoms will include fever, chills, rash, nausea. diarrhea, abdominal pain, pain at the surgical/infection site, vertigo, shortness of breath, hives or other rash. A baseline physical will be performed on enrollment and repeated each week at follow up visits. Labs will checked at baseline, then daily through hospitalization and then weekly. If patient develops persistent diarrhea a stool test for C. Diff PCR (polymerase chain reaction) will be performed.
Time Frame
Day one through one year after completion of study drug.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults > 18 years of age with the following osteoarticular infections:
Infected prosthetic knee or hip (first or second episode) with 2 stage procedure planned.
Criteria for infected joint:
Sinus tract which communicates with the joint
Preoperative diagnosis by diagnostic, culture positive arthrocentesis
Intraoperative diagnosis-evidence of purulence/inflammation is seen by the surgeon and/or the pathologist, and at least 2 intraoperative samples grow the same organism (only 1 needed if S. aureus) OR
Acute osteomyelitis of an extremity Criteria for acute osteomyelitis (all 4 needed)
Onset less than 4 weeks prior to evaluation
Radiographic (plain, MRI, TC) evidence of osteomyelitis
Positive culture from bone or blood culture with organism known to cause osteomyelitis
Orthopedic consultant must concur with diagnosis. PLUS: Positive bone/joint or blood culture for an organism known to cause osteomyelitis which is Ceftaroline susceptible
Exclusion criteria:
Immunocompromised hosts:
AIDS/HIV patients
Cancer requiring ongoing chemotherapy or radiation therapy steroid on an ongoing basis.
Any condition requiring > 20 mg prednisone or equivalent
TNF (tumor necrosing factor) inhibitor use (ongoing)
Organ transplant list
Diabetic foot infections
Osteomyelitis in association with decubitus ulcers
Vertebral osteomyelitis/spinal epidural abscess
Septic bursitis
Gonococcal arthritis
Ceftaroline nonsusceptible organisms isolated from bone, joint or blood.
Infected external fixation devices
Calculated creatinine clearance < 50 mL/min at baseline
History of severe penicillin/B lactam allergy (ID to evaluate)
Intravenous drug use - lifetime exclusion
Patients with a nail puncture wound to foot
Patients at high risk for MDR (multidrug resistant) Gram negative organisms
Please note the use of antibiotic containing cement is not exclusion, as it represents standard of care in some of the infections to be studied
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark R. Wallace, MD
Organizational Affiliation
Orlando Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orlando Regional Medical Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
12. IPD Sharing Statement
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Ceftaroline in the Treatment of Bone and Joint Infections
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