OsteomyelitisPhase 4NCT02005068
Ceftaroline in the Treatment of Bone and Joint Infections
A Phase 4 study testing Ceftaroline in people with Osteomyelitis and Joint Infections, run by Orlando Health, Inc. at 1 site in United States.
Trial summary
This is a study to evaluate the efficacy of Ceftaroline in the treatment of bone and joint infections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteomyelitis, Joint Infections
- What is being tested?
- Ceftaroline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Jul 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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)
- Intravenous drug use - lifetime exclusion
- Patients with a nail puncture wound to foot
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Orlando Regional Medical Center
Orlando, Florida, 32806
About this study
This is a study to evaluate the efficacy of Ceftaroline in the treatment of bone and joint infections.
Read the detailed description
Study evaluates the efficacy of Ceftaroline 600mg IV every 8 hours for the treatment of acute osteomyelitis and/or infected joints.
- Conditions
- Osteomyelitis, Joint Infections
- Being tested
- Ceftaroline
- Keywords
- Osteoarticular infections, Osteomyelitis, Joint infections, MRSA (Methicillin- Resistant Staphylococcus Aureus), MSSA (Methicillin- Susceptible Staphylococcus Aureus)
- Medical subject headings
- Osteomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CeftarolineDrug
Also called Teflaro, Ceftaroline fosamil, PPI-0903, TAK-599,
The duration of treatment will vary based on type of infection (acute osteomyelitis or joint infection) and if MRSA positive or negative.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Ceftaroline |
| Prosthetic joint infection | Experimental | For treatment of prosthetic joint infection Ceftaroline 600 mg IV every 8 hours for 6 weeks. Receives: Drug: Ceftaroline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year after study drug completion
Secondary outcomes (1)
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.
Measured: 30 days after conclusion of study antibiotic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startApr 2013
- Primary completionJul 2014
- Study completionJul 2014
Why it stopped: Failed to enroll any patients despite study modifications
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteomyelitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orlando Health, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Forest Laboratories
- Responsible party
- Principal investigator, Mark Wallace MD, Orlando Health, Inc.
- Investigators
- Mark R. Wallace, MD, Principal investigator, Orlando Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02005068
- Sponsor's protocol ID
- TEF-IT-17
- Status last verified
- Aug 2014
- First submitted
- 21 Nov 2013
- Last updated
- 7 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ceftaroline in the Treatment of Bone and Joint Infections
- ClinicalTrials.gov ID
- NCT02005068
- Acronym / sponsor ID
- TEF-IT-17
- Conditions
- Osteomyelitis, Joint Infections
- Keywords
- Osteoarticular infections, Osteomyelitis, Joint infections, MRSA (Methicillin- Resistant Staphylococcus Aureus), MSSA (Methicillin- Susceptible Staphylococcus Aureus)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Failed to enroll any patients despite study modifications
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Orlando Health, Inc.University, hospital or other
- Collaborators
- Forest Laboratories
- Study start
- Apr 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 9 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study to evaluate the efficacy of Ceftaroline in the treatment of bone and joint infections.
Detailed description
Study evaluates the efficacy of Ceftaroline 600mg IV every 8 hours for the treatment of acute osteomyelitis and/or infected joints.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acute Osteomyelitis - Non MRSA | Experimental | Drug: CeftarolineFor treatment of Acute osteomyelitis (< 6 months duration) Non MRSA isolate- Ceftaroline 600 MG (milligram) IV (intra-venous) every 8 hours for 6 weeks. |
| Acute osteomyelitis MRSA isolate | Experimental | Drug: CeftarolineFor treatment of Acute osteomyelitis (< 6 months duration) MRSA isolate- Ceftaroline 600 MG IV every 8 hours for 8 weeks. |
| Prosthetic joint infection | Experimental | Drug: CeftarolineFor treatment of prosthetic joint infection Ceftaroline 600 mg IV every 8 hours for 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Adults > 18 years of age with the following osteoarticular infections:
Key exclusion criteria (19 listed)
- Immunocompromised hosts:
- Diabetic foot infections
- Osteomyelitis in association with decubitus ulcers
- Vertebral osteomyelitis/spinal epidural abscess
- Septic bursitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CeftarolineAlso: Teflaro, Ceftaroline fosamil, PPI-0903, TAK-599,The duration of treatment will vary based on type of infection (acute osteomyelitis or joint infection) and if MRSA positive or negative. | Drug | Acute Osteomyelitis - Non MRSA, Acute osteomyelitis MRSA isolate, Prosthetic joint infection |
Primary outcome
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 secondary outcome
Initial clinical success from the treated osteoarticular infection
Time frame: 30 days after conclusion of study antibiotic
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark R. Wallace, MD principal investigator
Orlando Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ceftaroline in people with Osteomyelitis and Joint Infections, run by Orlando Health, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained clinical remission from the treated osteoarticular infection (time frame: 1 year after study drug completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2014.