Total Hip Replacement SurgeryPhase 1NCT00771524
Pharmacokinetic Study of the Penetration of Ceftobiprole in the Bone
A Phase 1 study testing Ceftobiprole in people with Total Hip Replacement Surgery, run by Basilea Pharmaceutica.
Trial summary
This study is being performed to measure the amount of the antibiotic ceftobiprole (study drug) found in the bone and blood after receiving one dose prior to your elective hip replacement surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Hip Replacement Surgery
- What is being tested?
- Ceftobiprole
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Apr 2009to Feb 2010
- Phase
- Phase 1
- 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
- Healthy men and women at least 18 years of age who have elected to undergo hip replacement surgery. Subjects must be in overall good health with normal renal function (a creatinine clearance of >50 mL/min).
Who cannot join
- Subjects must not have a history of repeated severe nausea with anesthesia, gastric or duodenal ulcer, allergy to b lactam antibiotics, urinary obstruction or difficulty in voiding.
About this study
Official title: Open-Label, Pharmacokinetic Study of the Penetration of Ceftobiprole Into Bone
This study is being performed to measure the amount of the antibiotic ceftobiprole (study drug) found in the bone and blood after receiving one dose prior to your elective hip replacement surgery. A piece of your hip bone which will be removed as part of your surgery will be analyzed to determine how much ceftobiprole gets into the bone.
Read the detailed description
About 20 patients will take part in the study. Two patients will not receive ceftobiprole, but will receive an antibiotic that is normally given prior to elective hip replacement surgery. The remaining 18 patients will receive ceftobiprole 500 mg dripped into the vein over 2 hours. All patients will have a sample of bone taken during the surgery and blood samples taken at specific timepoints. The samples taken from the 2 patients who did not receive study drug will assist in the development of a test used to measure the study drug in the bone sample. This is an open-label, parallel group, pharmacokinetic study in healthy men and women who have been cleared medically for elective total hip replacement surgery. Healthy is defined as patients who are medically stable and cleared for elective surgery. The study has 4 phases: a screening phase of up to 21 days before the day of surgery; a pretreatment phase of up to 7 days before the day of surgery; a 1-day open-label treatment phase; an end-of-study phase (end-of-study procedures or at the time of early withdrawal); and a follow-up telephone contact approximately 1 week after the surgery to assess new and ongoing adverse events. Two control subjects will be enrolled; these patients will not receive ceftobiprole, but will undergo surgery and a bone sample, which will serve as a control for qualifying the bioanalytical assay. The remaining 36 patients will be randomized to 1 of 2 ceftobiprole treatments. The primary objective is to estimate the penetration of ceftobiprole into bone of otherwise healthy patients who are undergoing total hip replacement surgery. Safety and tolerability will also be assessed. Venous blood samples will be collected and analyzed for ceftobiprole concentrations using validated liquid-chromatography methodology, with tandem mass spectrometric detection. Bone samples will be analyzed for ceftobiprole by qualified liquid-chromatography methodology, with tandem mass spectrometric detection. Safety and tolerability will be evaluated throughout the study. Blood will be drawn for clinical laboratory tests and PK evaluations. A single dose of ceftobiprole 500 mg dripped into the vein over 2 hours, administered prior to elective hip replacement surgery.
- Conditions
- Total Hip Replacement Surgery
- Being tested
- Ceftobiprole
- Keywords
- Pharmacokinetics, Hip replacement, Ceftobiprole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CeftobiproleDrug
Ceftobiprole, 500 mg single 2 hour infusion prior to hip replacement surgery
| Study group | Role | What they receive |
|---|---|---|
| Ceftobiprole | Experimental | Ceftobiprole, 500 mg single 2 hour infusion prior to hip replacement surgery Receives: Drug: Ceftobiprole |
| Control | No intervention | Standard of care antibiotics prior to hip replacement surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to estimate the penetration of ceftobiprole into bone in otherwise healthy patients who are undergoing total hip replacement surgery.
Measured: 1 week
Secondary outcomes (1)
Safety and tolerability will also be assessed.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2008 (estimated)
- Study startApr 2009
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip Replacement SurgeryStudies 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 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Basilea Pharmaceutica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial, Study director, Ortho-McNeil Janssen Scientific Affairs, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00771524
- Sponsor's protocol ID
- CR014227
- Other IDs
- PED-1001
- Status last verified
- Jul 2012
- First submitted
- 10 Oct 2008
- Last updated
- 30 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Pharmacokinetic Study of the Penetration of Ceftobiprole Into Bone
- ClinicalTrials.gov ID
- NCT00771524
- Acronym / sponsor ID
- CR014227
- Conditions
- Total Hip Replacement Surgery
- Keywords
- Pharmacokinetics, Hip replacement, Ceftobiprole
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Basilea PharmaceuticaIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 13 Oct 2008 (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 study is being performed to measure the amount of the antibiotic ceftobiprole (study drug) found in the bone and blood after receiving one dose prior to your elective hip replacement surgery. A piece of your hip bone which will be removed as part of your surgery will be analyzed to determine how much ceftobiprole gets into the bone.
Detailed description
About 20 patients will take part in the study. Two patients will not receive ceftobiprole, but will receive an antibiotic that is normally given prior to elective hip replacement surgery. The remaining 18 patients will receive ceftobiprole 500 mg dripped into the vein over 2 hours. All patients will have a sample of bone taken during the surgery and blood samples taken at specific timepoints. The samples taken from the 2 patients who did not receive study drug will assist in the development of a test used to measure the study drug in the bone sample. This is an open-label, parallel group, pharmacokinetic study in healthy men and women who have been cleared medically for elective total hip replacement surgery. Healthy is defined as patients who are medically stable and cleared for elective surgery. The study has 4 phases: a screening phase of up to 21 days before the day of surgery; a pretreatment phase of up to 7 days before the day of surgery; a 1-day open-label treatment phase; an end-of-study phase (end-of-study procedures or at the time of early withdrawal); and a follow-up telephone contact approximately 1 week after the surgery to assess new and ongoing adverse events. Two control subjects will be enrolled; these patients will not receive ceftobiprole, but will undergo surgery and a bone sample, which will serve as a control for qualifying the bioanalytical assay. The remaining 36 patients will be randomized to 1 of 2 ceftobiprole treatments. The primary objective is to estimate the penetration of ceftobiprole into bone of otherwise healthy patients who are undergoing total hip replacement surgery. Safety and tolerability will also be assessed. Venous blood samples will be collected and analyzed for ceftobiprole concentrations using validated liquid-chromatography methodology, with tandem mass spectrometric detection. Bone samples will be analyzed for ceftobiprole by qualified liquid-chromatography methodology, with tandem mass spectrometric detection. Safety and tolerability will be evaluated throughout the study. Blood will be drawn for clinical laboratory tests and PK evaluations. A single dose of ceftobiprole 500 mg dripped into the vein over 2 hours, administered prior to elective hip replacement surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ceftobiprole | Experimental | Drug: CeftobiproleCeftobiprole, 500 mg single 2 hour infusion prior to hip replacement surgery |
| Control | No intervention | –Standard of care antibiotics prior to hip replacement surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy men and women at least 18 years of age who have elected to undergo hip replacement surgery. Subjects must be in overall good health with normal renal function (a creatinine clearance of >50 mL/min).
Key exclusion criteria (1 listed)
- Subjects must not have a history of repeated severe nausea with anesthesia, gastric or duodenal ulcer, allergy to b lactam antibiotics, urinary obstruction or difficulty in voiding.
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 |
|---|---|---|
| CeftobiproleCeftobiprole, 500 mg single 2 hour infusion prior to hip replacement surgery | Drug | Ceftobiprole |
Primary outcome
The primary objective is to estimate the penetration of ceftobiprole into bone in otherwise healthy patients who are undergoing total hip replacement surgery.
Time frame: 1 week
1 secondary outcome
Safety and tolerability will also be assessed.
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2012.
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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.
Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial study director
Ortho-McNeil Janssen Scientific Affairs, LLC
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ceftobiprole in people with Total Hip Replacement Surgery, run by Basilea Pharmaceutica.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 30 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary objective is to estimate the penetration of ceftobiprole into bone in otherwise healthy patients who are undergoing total hip replacement surgery. (time frame: 1 week). 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 30 Jul 2012.