Ceftaroline in the Treatment of Bone and Joint Infections

• Status: Withdrawn
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a study to evaluate the efficacy of Ceftaroline in the treatment of bone and joint infections.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Orlando Health, Inc.
• Collaborator: Forest Laboratories
• Treatments: Ceftaroline fosamil; Cephalosporins; Methicillin

Criteria

Inclusion Criteria:

• Adults > 18 years of age with the following osteoarticular infections:

1. Infected prosthetic knee or hip (first or second episode) with 2 stage procedure planned.

Criteria for infected joint:

1. Sinus tract which communicates with the joint

2. Preoperative diagnosis by diagnostic, culture positive arthrocentesis

3. 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

2. Acute osteomyelitis of an extremity Criteria for acute osteomyelitis (all 4 needed)

1. Onset less than 4 weeks prior to evaluation

2. Radiographic (plain, MRI, TC) evidence of osteomyelitis

3. Positive culture from bone or blood culture with organism known to cause osteomyelitis

4. 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:

1. Immunocompromised hosts:

1. AIDS/HIV patients

2. Cancer requiring ongoing chemotherapy or radiation therapy steroid on an ongoing basis.

3. Any condition requiring > 20 mg prednisone or equivalent

4. TNF (tumor necrosing factor) inhibitor use (ongoing)

5. Organ transplant list

2. Diabetic foot infections

3. Osteomyelitis in association with decubitus ulcers

4. Vertebral osteomyelitis/spinal epidural abscess

5. Septic bursitis

6. Gonococcal arthritis

7. Ceftaroline nonsusceptible organisms isolated from bone, joint or blood.

8. Infected external fixation devices

9. Calculated creatinine clearance < 50 mL/min at baseline

10. History of severe penicillin/B lactam allergy (ID to evaluate)

11. Intravenous drug use - lifetime exclusion

12. Patients with a nail puncture wound to foot

13. 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