Ceftaroline in the Treatment of Bone and Joint Infections

Osteomyelitis Clinical Trial

Official title:

Ceftaroline in the Treatment of Bone and Joint Infections

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02005068
• Other study ID #: TEF-IT-17
• Status: Withdrawn
• Phase: Phase 4
• First received: November 21, 2013
• Last updated: August 6, 2014
• Start date: April 2013
• Est. completion date: July 2014

Study information

• Verified date: August 2014
• Source: Orlando Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis, Infectious
• Communicable Diseases
• Infection
• Joint Infections
• Osteomyelitis

Intervention

Drug:
• Ceftaroline
The duration of treatment will vary based on type of infection (acute osteomyelitis or joint infection) and if MRSA positive or negative.

Locations

Country	Name	City	State
United States	Orlando Regional Medical Center	Orlando	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Orlando Health, Inc.	Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants with defined symptoms, signs and lab values as markers of safety and tolerance.	Symptoms will be assessed daily by study team while patient is hospitalized and reviewed weekly by investigator while the patient is receiving study drug. Specific symptoms will include fever, chills, rash, nausea. diarrhea, abdominal pain, pain at the surgical/infection site, vertigo, shortness of breath, hives or other rash. A baseline physical will be performed on enrollment and repeated each week at follow up visits. Labs will checked at baseline, then daily through hospitalization and then weekly. If patient develops persistent diarrhea a stool test for C. Diff PCR (polymerase chain reaction) will be performed.	Day one through one year after completion of study drug.	Yes
Primary	Sustained clinical remission from the treated osteoarticular infection	Sustained clinical remission is defined by the absence of either clinical or microbiological evidence of failure at 1 year after study drug completion, in patients who complete the protocol's antibiotic regimen(s) and did not require subsequent antibiotics for their osteoarticular infection beyond the protocol prescribed regimen.	1 year after study drug completion	No
Secondary	Initial clinical success from the treated osteoarticular infection	Initial clinical success will be measured by the agreement of the Infectious disease consultant and Orthopedic surgeon that the patient has had a positive response to therapy. Success will be measured by decrease of CRP (C reactive protein) by 50% from baseline if initially elevated, no evidence of drainage, sinus tract formation or infection related bone instability. Follow up cultures, if available are negative for originally isolated organism. In patients with prothetic joints no new warmth, tenderness or inflammation.	30 days after conclusion of study antibiotic	No