BacteremiaPhase 2NCT00505258
Ceftobiprole in the Treatment of Hospitalized Patients With Staphylococcus Aureus Bacteremia
A Phase 2 study testing ceftobiprole medocaril in people with Bacteremia, run by Basilea Pharmaceutica.
Trial summary
The purpose of this study is to assess the safety and efficacy of ceftobiprole versus a comparator in hospitalized patients with bacteremia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacteremia
- What is being tested?
- ceftobiprole medocaril
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Apr 2009
- Phase
- Phase 2
- 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
- Hospitalized patients with signs and symptoms suggestive of systemic staphylococcal infection as defined in the protocol
- Female patients must be postmenopausal (for at least 1 year), surgically sterile or practicing an effective method of birth control, male partner sterilization or, at the discretion of the investigator, abstinence, before entry and throughout the study and have a negative urine pregnancy test (confirmed with a negative serum pregnancy test) at screening.
Who cannot join
- Female patients who are pregnant or lactating
- Known or suspected hypersensitivity to beta-lactam antibiotics or any other study medications
- Receipt of vancomycin or other antistaphylococcal drug for > 2 calendar days prior to initiation of study drug
- Diagnosis of a catheter-related GPC-cl bacteremia at the time of study enrollment
- Clinical findings of left-sided endocarditis prior to enrollment or any time during study participation
- Requirement for surgery during the seven days of study therapy administration with the exception of surgery required to manage a complication of S. aureus bacteremia
About this study
Official title: Randomized, Open-Label Study Evaluating the Safety and Rate of Bacterial Clearance of Ceftobiprole 500 Milligram Every 8 Hours Compared to Conventional Therapy in the Treatment of Hospitalized Subjects With Staphylococcus Aureus Bacteremia
The purpose of this study is to assess the safety and efficacy of ceftobiprole versus a comparator in hospitalized patients with bacteremia.
Read the detailed description
Ceftobiprole medocaril is a cephalosporin antibiotic with anti-MRSA (Methicillin-Resistant Staphylococcus aureus) activity. Ceftobiprole medocaril in not approved for the treatment of bacterial blood stream infections. S. aureus is a major human pathogen. It causes a wide range of serious infections, including skin and skin structure infections, infections of vascular devices and catheters, and infections of the heart and lungs, bones and joints, and deep tissues. Particularly challenging and difficult to treat are blood-borne infections (bacteremia). Bacteremic infections are prone to relapse and they are often complicated by metastatic seeding of sites throughout the body. MRSA strains are increasing in prevalence, incidence, and virulence. Moreover, the frequency of patients presenting with persistent MRSA bacteremia appears to be rising. The objective of the open label trial is to compare the effectiveness and safety of ceftobiprole versus a comparator in patients with MRSA and MSSA (methicillin-susceptible Staphylococcus aureus) in bacteremic patients. Patients who meet inclusion and exclusion criteria and consent to participate in the study will be randomly assigned to either ceftobiprole or comparator. The primary end point is time to bloodstream clearance of MRSA and MSSA in patients. Patients will be randomized to either ceftobiprole or comparator for 7 days.
- Conditions
- Bacteremia
- Being tested
- ceftobiprole medocaril
- Keywords
- Bacteremia, Bloodstream infection, Staphylococcus aureus, Staphylococcal Infections, MRSA, MSSA
- Medical subject headings
- Bacteremia, Sepsis, Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ceftobiprole medocarilDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the effect of ceftobiprole on the time to bloodstream clearance of methicillin-resistant Staphylococcus aureus and methicillin-susceptible Staphylococcus aureus (MSSA) in treated bacteremic patients.
Secondary outcomes (1)
To determine the effect of ceftobiprole versus comparator on the time to bloodstream clearance of MRSA and MSSA, respectively and bloodstream clearance of MRSA compared to MSSA in bacteremic patients.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2007 (estimated)
- Study completionApr 2009 (estimated)
Why it stopped: The study was withdrawn due to lack of an appropriate patient population.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BacteremiaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 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
- NCT00505258
- Sponsor's protocol ID
- CR013807
- Status last verified
- Feb 2013
- First submitted
- 19 Jul 2007
- Last updated
- 20 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open-Label Study Evaluating the Safety and Rate of Bacterial Clearance of Ceftobiprole 500 Milligram Every 8 Hours Compared to Conventional Therapy in the Treatment of Hospitalized Subjects With Staphylococcus Aureus Bacteremia
- ClinicalTrials.gov ID
- NCT00505258
- Acronym / sponsor ID
- CR013807
- Conditions
- Bacteremia
- Keywords
- Bacteremia, Bloodstream infection, Staphylococcus aureus, Staphylococcal Infections, MRSA, MSSA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was withdrawn due to lack of an appropriate patient population.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Basilea PharmaceuticaIndustry (pharma, biotech, devices)
- Study completion
- Apr 2009 (estimated)
- First posted
- 23 Jul 2007 (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.
The purpose of this study is to assess the safety and efficacy of ceftobiprole versus a comparator in hospitalized patients with bacteremia.
Detailed description
Ceftobiprole medocaril is a cephalosporin antibiotic with anti-MRSA (Methicillin-Resistant Staphylococcus aureus) activity. Ceftobiprole medocaril in not approved for the treatment of bacterial blood stream infections. S. aureus is a major human pathogen. It causes a wide range of serious infections, including skin and skin structure infections, infections of vascular devices and catheters, and infections of the heart and lungs, bones and joints, and deep tissues. Particularly challenging and difficult to treat are blood-borne infections (bacteremia). Bacteremic infections are prone to relapse and they are often complicated by metastatic seeding of sites throughout the body. MRSA strains are increasing in prevalence, incidence, and virulence. Moreover, the frequency of patients presenting with persistent MRSA bacteremia appears to be rising. The objective of the open label trial is to compare the effectiveness and safety of ceftobiprole versus a comparator in patients with MRSA and MSSA (methicillin-susceptible Staphylococcus aureus) in bacteremic patients. Patients who meet inclusion and exclusion criteria and consent to participate in the study will be randomly assigned to either ceftobiprole or comparator. The primary end point is time to bloodstream clearance of MRSA and MSSA in patients. Patients will be randomized to either ceftobiprole or comparator for 7 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Hospitalized patients with signs and symptoms suggestive of systemic staphylococcal infection as defined in the protocol
- Female patients must be postmenopausal (for at least 1 year), surgically sterile or practicing an effective method of birth control, male partner sterilization or, at the discretion of the investigator, abstinence, before entry and throughout the study and have a negative urine pregnancy test (confirmed with a negative serum pregnancy test) at screening.
Key exclusion criteria (6 listed)
- Female patients who are pregnant or lactating
- Known or suspected hypersensitivity to beta-lactam antibiotics or any other study medications
- Receipt of vancomycin or other antistaphylococcal drug for > 2 calendar days prior to initiation of study drug
- Diagnosis of a catheter-related GPC-cl bacteremia at the time of study enrollment
- Clinical findings of left-sided endocarditis prior to enrollment or any time during study participation
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 |
|---|---|---|
| ceftobiprole medocaril | Drug | – |
Primary outcome
To determine the effect of ceftobiprole on the time to bloodstream clearance of methicillin-resistant Staphylococcus aureus and methicillin-susceptible Staphylococcus aureus (MSSA) in treated bacteremic patients.
1 secondary outcome
To determine the effect of ceftobiprole versus comparator on the time to bloodstream clearance of MRSA and MSSA, respectively and bloodstream clearance of MRSA compared to MSSA in bacteremic patients.
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 20 Feb 2013.
Related trials for Bacteremia
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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 2 study testing ceftobiprole medocaril in people with Bacteremia, 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 2 inclusion and 6 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 20 Feb 2013. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
To determine the effect of ceftobiprole on the time to bloodstream clearance of methicillin-resistant Staphylococcus aureus and methicillin-susceptible Staphylococcus aureus (MSSA) in treated bacteremic patients.. 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 20 Feb 2013.