Trial record 9 of 12 for:    Open Studies | "Arthritis, Infectious"

Ceftaroline in the Treatment of Bone and Joint Infections

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Orlando Health, Inc.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Mark Wallace MD, Orlando Health, Inc.
ClinicalTrials.gov Identifier:
NCT02005068
First received: November 21, 2013
Last updated: December 3, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention Phase
Osteomyelitis
Joint Infections
Drug: Ceftaroline
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ceftaroline in the Treatment of Bone and Joint Infections

Resource links provided by NLM:


Further study details as provided by Orlando Health, Inc.:

Primary Outcome Measures:
  • Sustained clinical remission from the treated osteoarticular infection [ Time Frame: 1 year after study drug completion ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Initial clinical success from the treated osteoarticular infection [ Time Frame: 30 days after conclusion of study antibiotic ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 30
Study Start Date: April 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Ceftaroline
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
  • Ceftaroline fosamil
  • PPI-0903
  • 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.
Drug: Ceftaroline
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
  • Ceftaroline fosamil
  • PPI-0903
  • 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.
Drug: Ceftaroline
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
  • Ceftaroline fosamil
  • PPI-0903
  • 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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02005068

Contacts
Contact: Mark R Wallace, MD 407.423.1039 Mark.Wallace@orlandohealth.com
Contact: Mary C Bowman, MD 407.423.1039 Mary.Bowman@orlandohealth.com

Locations
United States, Florida
Orlando Regional Medical Center Recruiting
Orlando, Florida, United States, 32806
Contact: Mark R. Wallace, MD    407-423-1039    Mark.Wallace@orlandohealth.com   
Contact: Paula H. Willett, RN    321.841.9623    Paula.Willett@orlandohealth.com   
Sponsors and Collaborators
Orlando Health, Inc.
Forest Laboratories
Investigators
Principal Investigator: Mark R. Wallace, MD Orlando Health
  More Information

No publications provided

Responsible Party: Mark Wallace MD, Infectious Disease Faculty Practice, Orlando Health, Inc.
ClinicalTrials.gov Identifier: NCT02005068     History of Changes
Other Study ID Numbers: TEF-IT-17
Study First Received: November 21, 2013
Last Updated: December 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Orlando Health, Inc.:
Osteoarticular infections
Osteomyelitis
Joint infections
MRSA (Methicillin- Resistant Staphylococcus Aureus)
MSSA (Methicillin- Susceptible Staphylococcus Aureus)

Additional relevant MeSH terms:
Osteomyelitis
Arthritis, Infectious
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Arthritis
Joint Diseases

ClinicalTrials.gov processed this record on July 23, 2014