Ceftaroline in the Treatment of Bone and Joint Infections

August 6, 2014 updated by: Mark Wallace MD, Orlando Health, Inc.
This is a study to evaluate the efficacy of Ceftaroline in the treatment of bone and joint infections.

Study Overview

Status

Withdrawn

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Florida
      • Orlando, Florida, United States, 32806
        • Orlando Regional Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acute Osteomyelitis - Non MRSA
For treatment of Acute osteomyelitis (< 6 months duration) Non MRSA isolate- Ceftaroline 600 MG (milligram) IV (intra-venous) every 8 hours for 6 weeks.
The duration of treatment will vary based on type of infection (acute osteomyelitis or joint infection) and if MRSA positive or negative.
Other Names:
  • Teflaro
  • PPI-0903
  • Ceftaroline fosamil
  • TAK-599,
  • ceftaroline acetate
  • ceftaroline prodrug
  • ceftaroline fosamil for injection
  • Ceftaroline: PPI-0903M
  • T 91825
  • Chemical Name (6R,7R)-7-{(2Z)-2-(ethoxyimino)-2-[5-
  • (phosphonoamino)-1,2,4-thiadiazol-3-
  • yl]acetamino}-3-[(4-(1-methylpyridin-1-ium-4-yl)-
  • 1,3-thiazol-2-yl]sulfanyl}-8-oxo-5-thia-1-
  • azabicyclo[4.2.0]oct-2-ene-2-carboxylate
Experimental: Acute osteomyelitis MRSA isolate
For treatment of Acute osteomyelitis (< 6 months duration) MRSA isolate- Ceftaroline 600 MG IV every 8 hours for 8 weeks.
The duration of treatment will vary based on type of infection (acute osteomyelitis or joint infection) and if MRSA positive or negative.
Other Names:
  • Teflaro
  • PPI-0903
  • Ceftaroline fosamil
  • TAK-599,
  • ceftaroline acetate
  • ceftaroline prodrug
  • ceftaroline fosamil for injection
  • Ceftaroline: PPI-0903M
  • T 91825
  • Chemical Name (6R,7R)-7-{(2Z)-2-(ethoxyimino)-2-[5-
  • (phosphonoamino)-1,2,4-thiadiazol-3-
  • yl]acetamino}-3-[(4-(1-methylpyridin-1-ium-4-yl)-
  • 1,3-thiazol-2-yl]sulfanyl}-8-oxo-5-thia-1-
  • azabicyclo[4.2.0]oct-2-ene-2-carboxylate
Experimental: Prosthetic joint infection
For treatment of prosthetic joint infection Ceftaroline 600 mg IV every 8 hours for 6 weeks.
The duration of treatment will vary based on type of infection (acute osteomyelitis or joint infection) and if MRSA positive or negative.
Other Names:
  • Teflaro
  • PPI-0903
  • Ceftaroline fosamil
  • TAK-599,
  • ceftaroline acetate
  • ceftaroline prodrug
  • ceftaroline fosamil for injection
  • Ceftaroline: PPI-0903M
  • T 91825
  • Chemical Name (6R,7R)-7-{(2Z)-2-(ethoxyimino)-2-[5-
  • (phosphonoamino)-1,2,4-thiadiazol-3-
  • yl]acetamino}-3-[(4-(1-methylpyridin-1-ium-4-yl)-
  • 1,3-thiazol-2-yl]sulfanyl}-8-oxo-5-thia-1-
  • azabicyclo[4.2.0]oct-2-ene-2-carboxylate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sustained clinical remission from the treated osteoarticular infection
Time Frame: 1 year after study drug completion
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Initial clinical success from the treated osteoarticular infection
Time Frame: 30 days after conclusion of study antibiotic
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with defined symptoms, signs and lab values as markers of safety and tolerance.
Time Frame: Day one through one year after completion of study drug.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Mark R. Wallace, MD, Orlando Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

November 21, 2013

First Submitted That Met QC Criteria

December 3, 2013

First Posted (Estimate)

December 9, 2013

Study Record Updates

Last Update Posted (Estimate)

August 7, 2014

Last Update Submitted That Met QC Criteria

August 6, 2014

Last Verified

August 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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