Ceftaroline in the Treatment of Bone and Joint Infections

Withdrawn before enrolling · Phase 4

Conditions studied: Osteomyelitis, Joint Infections

In brief

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

Key facts

Study ID

NCT02005068

Run by

Orlando Health, Inc.

People needed

0

Starts

2013-04-01

Expected to finish

2014-07-01

Last updated by the study team

2014-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Orlando Regional Medical Center — Orlando, Florida, United States

Full record on ClinicalTrials.gov

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