Clinical trial NCT02005068: Ceftaroline in the Treatment of Bone and Joint Infections
Official title: Ceftaroline in the Treatment of Bone and Joint Infections
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Osteomyelitis
Joint Infections
Keywords: Osteoarticular infections
Osteomyelitis
Joint infections
MRSA (Methicillin- Resistant Staphylococcus Aureus)
MSSA (Methicillin- Susceptible Staphylococcus Aureus)
Lead sponsor: Orlando Health, Inc.
Sponsor class: OTHER
Collaborators: name: Forest Laboratories
First posted: 2013-12-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Sustained clinical remission from the treated osteoarticular infection
timeFrame: 1 year after study drug completion
Secondary outcomes:
measure: Initial clinical success from the treated osteoarticular infection
timeFrame: 30 days after conclusion of study antibiotic
Other outcomes:
measure: Number of participants with defined symptoms, signs and lab values as markers of safety and tolerance.
timeFrame: Day one through one year after completion of study drug.
Locations:
city: Orlando
country: United States
facility: Orlando Regional Medical Center
state: Florida
Study officials:
affiliation: Orlando Health
name: Mark R. Wallace, MD
role: PRINCIPAL_INVESTIGATOR
References: