Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2025-12-24 @ 5:32 PM
NCT ID:
NCT02005068
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02005068
Study Brief:
Protocol Section:
NCT02005068