Ceftaroline in the Treatment of Bone and Joint Infections

NCT02005068 | Withdrawn Phase 4

• 1 other identifier: TEF-IT-17
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Osteomyelitis; Joint Infections

Keywords

Osteoarticular infections; Osteomyelitis; Joint infections; MRSA (Methicillin- Resistant Staphylococcus Aureus); MSSA (Methicillin- Susceptible Staphylococcus Aureus)

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Initial clinical success from the treated osteoarticular infection

  30 days after conclusion of study antibiotic

Other Outcomes (1)

• Number of participants with defined symptoms, signs and lab values as markers of safety and tolerance.

  Day one through one year after completion of study drug.

Study Arms (3)

Acute Osteomyelitis - Non MRSA

EXPERIMENTAL

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

Acute osteomyelitis MRSA isolate

EXPERIMENTAL

For treatment of Acute osteomyelitis (\< 6 months duration) MRSA isolate- Ceftaroline 600 MG IV every 8 hours for 8 weeks.

Drug: Ceftaroline

Prosthetic joint infection

EXPERIMENTAL

For treatment of prosthetic joint infection Ceftaroline 600 mg IV every 8 hours for 6 weeks.

Drug: Ceftaroline

Interventions

Ceftaroline DRUG

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

Also known as: 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

Acute Osteomyelitis - Non MRSA; Acute osteomyelitis MRSA isolate; Prosthetic joint infection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults \> 18 years of age with the following osteoarticular infections:
• Infected prosthetic knee or hip (first or second episode) with 2 stage procedure planned.
• Criteria for infected joint:
• Sinus tract which communicates with the joint
• Preoperative diagnosis by diagnostic, culture positive arthrocentesis
• 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
• Acute osteomyelitis of an extremity Criteria for acute osteomyelitis (all 4 needed)
• Onset less than 4 weeks prior to evaluation
• Radiographic (plain, MRI, TC) evidence of osteomyelitis
• Positive culture from bone or blood culture with organism known to cause osteomyelitis
• Orthopedic consultant must concur with diagnosis. PLUS: Positive bone/joint or blood culture for an organism known to cause osteomyelitis which is Ceftaroline susceptible

You may not qualify if:

• Immunocompromised hosts:
• AIDS/HIV patients
• Cancer requiring ongoing chemotherapy or radiation therapy steroid on an ongoing basis.
• Any condition requiring \> 20 mg prednisone or equivalent
• TNF (tumor necrosing factor) inhibitor use (ongoing)
• Organ transplant list
• Diabetic foot infections
• Osteomyelitis in association with decubitus ulcers
• Vertebral osteomyelitis/spinal epidural abscess
• Septic bursitis
• Gonococcal arthritis
• Ceftaroline nonsusceptible organisms isolated from bone, joint or blood.
• Infected external fixation devices
• Calculated creatinine clearance \< 50 mL/min at baseline
• History of severe penicillin/B lactam allergy (ID to evaluate)

Sponsors & Collaborators

• Orlando Health, Inc.: lead
• Forest Laboratories: collaborator

Study Sites (1)

Orlando Regional Medical Center

Orlando, Florida, 32806, United States

Location

MeSH Terms

Conditions

Osteomyelitis

Interventions

Ceftaroline; Injections

Condition Hierarchy (Ancestors)

Bone Diseases, Infectious; Infections; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Mark R. Wallace, MD

  Orlando Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Infectious Disease Faculty Practice

Study Record Dates

• First Submitted: November 21, 2013
• First Posted: December 9, 2013
• Study Start: April 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: August 7, 2014

Record last verified: 2014-08

Locations

US (1)