Ceftaroline in the Treatment of Bone and Joint Infections

Orlando Health, Inc.

Status and phase: Withdrawn; Phase 4

Conditions: Joint Infections; Osteomyelitis

Treatments: Drug: Ceftaroline

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02005068

TEF-IT-17

Details and patient eligibility

About

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

Full description

Study evaluates the efficacy of Ceftaroline 600mg IV every 8 hours for the treatment of acute osteomyelitis and/or infected joints.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

Acute Osteomyelitis - Non MRSA

Experimental group

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.

Treatment:

Drug: Ceftaroline

Acute osteomyelitis MRSA isolate

Experimental group

Description:

For treatment of Acute osteomyelitis (\< 6 months duration) MRSA isolate- Ceftaroline 600 MG IV every 8 hours for 8 weeks.

Treatment:

Drug: Ceftaroline

Prosthetic joint infection

Experimental group

Description:

For treatment of prosthetic joint infection Ceftaroline 600 mg IV every 8 hours for 6 weeks.

Treatment:

Drug: Ceftaroline