WithdrawnPhase 4

Ceftaroline in the Treatment of Bone and Joint Infections

Stopped: Failed to enroll any patients despite study modifications

United States0Started 2013-04

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

✕. 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

Sustained clinical remission from the treated osteoarticular infection

Timeframe: 1 year after study drug completion

NCT IDNCT02005068

SponsorOrlando Health, Inc.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-07