Ceftaroline in the Treatment of Bone and Joint Infections

Phase 4

Withdrawn

• Conditions: Joint Infections; Osteomyelitis
• Interventions: Drug: Ceftaroline

• Registration Number: NCT02005068
• Lead Sponsor: Orlando Health, Inc.

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.

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-11-21
• Study First Submitted QC: 2013-12-03
• Study First Posted: 2013-12-09
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-06
• Last Update Posted: 2014-08-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acute Osteomyelitis - Non MRSA	Ceftaroline	For treatment of Acute osteomyelitis (\< 6 months duration) Non MRSA isolate- Ceftaroline 600 MG (milligram) IV (intra-venous) every 8 hours for 6 weeks.
Acute osteomyelitis MRSA isolate	Ceftaroline	For treatment of Acute osteomyelitis (\< 6 months duration) MRSA isolate- Ceftaroline 600 MG IV every 8 hours for 8 weeks.
Prosthetic joint infection	Ceftaroline	For treatment of prosthetic joint infection Ceftaroline 600 mg IV every 8 hours for 6 weeks.

Primary Outcome Measures

Name	Time	Method
Sustained clinical remission from the treated osteoarticular infection	1 year after study drug completion	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

Name	Time	Method
Initial clinical success from the treated osteoarticular infection	30 days after conclusion of study antibiotic	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.

Trial Locations

Locations (1)

Orlando Regional Medical Center; 🇺🇸 Orlando, Florida, United States