Open FracturesPhase 4NCT02937181
Antibiotic Prophylaxis in Open Fractures
A Phase 4 study testing Ceftaroline in people with Open Fractures, run by Olayemi Osiyemi MD at 1 site in United States.
Trial summary
Prospective look at antibiotic prophylaxis with Ceftaroline in patients with type II and III open fractures Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Open Fractures
- 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
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to Mar 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male or female >= 18 years old
- complete an informed consent
- patients are diagnosed with a type II or III open fracture
Who cannot join
- allergy to beta-lactam antibiotics prior to screening
- prior to enrollment: patients received 3 or more doses of antibiotic prophylaxis
- pregnant female
- inability to provide consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Triple O Research Institute PA
West Palm Beach, Florida, 33401
About this study
Official title: Antibiotic Prophylaxis With Ceftaroline for Type II and II Open Fractures: a Phase 4, Open-label, Prospective Clinical Trial
Prospective look at antibiotic prophylaxis with Ceftaroline in patients with type II and III open fractures
Read the detailed description
Determine if antibiotic prophylaxis with Ceftaroline in patients with type II and III open fractures is a safe and effective alternative to standard combination therapy
- Conditions
- Open Fractures
- Being tested
- Ceftaroline
- Medical subject headings
- Fractures, Open
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CeftarolineDrug
Also called Teflaro
IV Ceftaroline will be given for 72 hours
| Study group | Role | What they receive |
|---|---|---|
| open fractures type II and III | Experimental | Every patients will receive Ceftaroline in an open label, single arm Receives: Drug: Ceftaroline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of fracture site infection at 30 days between ceftaroline and historical hospital rate
Measured: 30 days
Secondary outcomes (1)
Incidence of acute kidney injury
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study startDec 2016
- Primary completionOct 2018 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open FracturesStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Olayemi Osiyemi MD
- Sponsor type
- University, hospital or other
- Collaborators
- Forest Laboratories
- Responsible party
- Sponsor-investigator, Olayemi Osiyemi MD, Triple O Research Institute PA
- Investigators
- Olayemi Osiyemi, MD, Principal investigator, Triple O Research Institute PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02937181
- Sponsor's protocol ID
- TEF-IT-40B
- Status last verified
- Oct 2016
- First submitted
- 14 Oct 2016
- Last updated
- 28 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: no personal data, identifier and the data are made available
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Prophylaxis With Ceftaroline for Type II and II Open Fractures: a Phase 4, Open-label, Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT02937181
- Acronym / sponsor ID
- TEF-IT-40B
- Conditions
- Open Fractures
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Olayemi Osiyemi MDUniversity, hospital or other
- Collaborators
- Forest Laboratories
- Study start
- Dec 2016
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 18 Oct 2016 (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.
Prospective look at antibiotic prophylaxis with Ceftaroline in patients with type II and III open fractures
Detailed description
Determine if antibiotic prophylaxis with Ceftaroline in patients with type II and III open fractures is a safe and effective alternative to standard combination therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| open fractures type II and III | Experimental | Drug: CeftarolineEvery patients will receive Ceftaroline in an open label, single arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- male or female >= 18 years old
- complete an informed consent
- patients are diagnosed with a type II or III open fracture
Key exclusion criteria (4 listed)
- allergy to beta-lactam antibiotics prior to screening
- prior to enrollment: patients received 3 or more doses of antibiotic prophylaxis
- pregnant female
- inability to provide consent
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: TeflaroIV Ceftaroline will be given for 72 hours | Drug | open fractures type II and III |
Primary outcome
Rate of fracture site infection at 30 days between ceftaroline and historical hospital rate
Time frame: 30 days
1 secondary outcome
Incidence of acute kidney injury
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2016.
- Individual participant dataSharing planned: Yes. no personal data, identifier and the data are made available
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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.
Olayemi Osiyemi, MD principal investigator
Triple O Research Institute PA
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 Open Fractures, run by Olayemi Osiyemi MD 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 28 Oct 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paul Glickman (561-855-7871, pglickman@tripleoresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of fracture site infection at 30 days between ceftaroline and historical hospital rate (time frame: 30 days). 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 28 Oct 2016.