PneumoniaPhase 3NCT00210964
Ceftobiprole in Hospital Acquired Pneumonia
A Phase 3 study testing linezolid plus ceftazidime in people with Pneumonia, run by Basilea Pharmaceutica.
Trial summary
The purpose of this study is to compare the clinical cure rate of ceftobiprole medocaril (the water-soluble prodrug [form] of ceftobiprole) referred to as ceftobiprole versus a comparator in the treatment of patients with nosocomial pneumonia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia
- What is being tested?
- linezolid plus ceftazidime
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 781 participants
- Where
- No sites listed yet
- Study dates
- Apr 2005to May 2007
- Phase
- Phase 3
- 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
- Patients suffering from nosocomial pneumonia or ventilator-associated pneumonia
- Female patients must be postmenopausal for at least 1 year, surgically sterile, or practicing an effective method of birth control, before entry and throughout the study, and have a negative serum or urine pregnancy test at the screening
Who cannot join
- Known or suspected hypersensitivity to any related antibiotic medications
- Any known or suspected condition or concurrent treatment that would be contraindicated by the prescribing information
- Treatment with any investigational drug within 30 days before enrollment
- Prior enrollment to this study
About this study
Official title: A Phase III Randomized Double-Blind Study Of Ceftobiprole Versus Linezolid Plus Ceftazidime In The Treatment Of Nosocomial Pneumonia
The purpose of this study is to compare the clinical cure rate of ceftobiprole medocaril (the water-soluble prodrug [form] of ceftobiprole) referred to as ceftobiprole versus a comparator in the treatment of patients with nosocomial pneumonia.
Read the detailed description
Ceftobiprole medocaril (the water-soluble prodrug [form] of ceftobiprole), referred to as ceftobiprole is a cephalosporin antibiotic with anti-MRSA (Methicillin-Resistant Staphylococcus Aureus) activity. Ceftobiprole is not yet approved for the treatment of nosocomial (hospital-acquired) pneumonia. This is a randomized, double-blind, multicenter study of ceftobiprole versus a comparator (linezolid plus ceftazidime) to assess the effectiveness and safety of ceftobiprole in patients with nosocomial pneumonia. The patients will be randomized to receive ceftobiprole plus placebo or the comparator. The primary endpoint is the clinical cure rate of ceftobiprole at the test-of-cure visit. The patients will receive either ceftobiprole plus placebo or the comparator for 7 to 14 days (unless extended at discretion of medical monitor). Patient safety will be monitored throughout the study. In December 2006, this study (BAP00307) and another similar study (BAP00248, see NCT00229008) were amended (changed) to create 1 study (BAP00248/307).Therefore, the results reported for this study will be combined with the results reported for study BAP00248. Patients will receive either ceftobiprole plus placebo or a comparator by intravenous infusion for 7 to 14 days (unless extended at discretion of medical monitor).
- Conditions
- Pneumonia
- Being tested
- ceftobiprole plus placebo, linezolid plus ceftazidime
- Keywords
- Ceftobiprole medocaril, Nosocominal Pneumonia, Ventilator-Associated Pneumonia, Cephalosporins, Methicillin-Resistant Staphylococcus Aureus
- Medical subject headings
- Pneumonia, Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ceftobiprole plus placeboDrug
ceftobiprole 500 mg every 8 hours as a 120 minute intravenous infusion and placebo administered every 12 hours as a 60-minute intravenous infusion for 7 to 14 days
linezolid plus ceftazidimeDrug
linezolid 600 mg every 12 hours as a 60-minute intravenous infusion plus ceftazidime 2 g every 8 hours as a 120-minute intravenous infusion for 7 to 14 days
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | ceftobiprole plus placebo ceftobiprole 500 mg every 8 hours as a 120 minute intravenous infusion and placebo administered every 12 hours as a 60-minute intravenous infusion for 7 to 14 days Receives: Drug: ceftobiprole plus placebo |
| 002 | Active comparator | linezolid plus ceftazidime linezolid 600 mg every 12 hours as a 60-minute intravenous infusion plus ceftazidime 2 g every 8 hours as a 120-minute intravenous infusion for 7 to 14 days Receives: Drug: linezolid plus ceftazidime |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical cure rate (the ratio of the number of clinically cured patients to the total number of patients in the population)
Measured: 7 to 14 days after the end-of-therapy (EOT)
Secondary outcomes (4)
Microbiological eradication rate
Measured: At the TOC visit defined as 7-14 days after the EOT
Clinical cure rate
Measured: At the late follow-up (LFU) visit defined as 28 to 35 days after the EOT
Microbiological eradication rates
Measured: At the LFU visit defined as 28 to 35 days after the EOT
Pneumonia-specific mortality rates
Measured: Within 30 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startApr 2005
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 781 participants (actual)
Sponsor and investigators
- Lead sponsor
- Basilea Pharmaceutica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00210964
- Sponsor's protocol ID
- CR005032
- Other IDs
- BAP00307
- Status last verified
- Aug 2012
- First submitted
- 13 Sep 2005
- Last updated
- 3 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hahn MM, Anderson MS, Snyder M, Du W, Chou Y-L, McCracken B, Smart JI, Litherland K, Keech S, von Siebenthal F, Jones M, Henning LN. Pharmacokinetic modeling and efficacy of ceftobiprole medocaril against pneumonic tularemia in cynomolgus macaques. Antimicrob Agents Chemother. 2025 Dec 10;69(12):e0127825. doi: 10.1128/aac.01278-25. Epub 2025 Nov 18.
PubMed 41251370Huang H, Gao L, Engelhardt M, Saulay M, Hamed K. A post hoc analysis of two Phase III trials showing the efficacy and tolerability of ceftobiprole in East Asian patients. Future Microbiol. 2021 Jul;16:783-796. doi: 10.2217/fmb-2021-0121. Epub 2021 Jun 22.
PubMed 34155899Welte T, Scheeren TW, Overcash JS, Saulay M, Engelhardt M, Hamed K. Efficacy and safety of ceftobiprole in patients aged 65 years or older: a post hoc analysis of three Phase III studies. Future Microbiol. 2021 May;16:543-555. doi: 10.2217/fmb-2021-0042. Epub 2021 May 7.
PubMed 33960817Scheeren TWL, Welte T, Saulay M, Engelhardt M, Santerre-Henriksen A, Hamed K. Early improvement in severely ill patients with pneumonia treated with ceftobiprole: a retrospective analysis of two major trials. BMC Infect Dis. 2019 Feb 26;19(1):195. doi: 10.1186/s12879-019-3820-y.
PubMed 30808293Awad SS, Rodriguez AH, Chuang YC, Marjanek Z, Pareigis AJ, Reis G, Scheeren TW, Sanchez AS, Zhou X, Saulay M, Engelhardt M. A phase 3 randomized double-blind comparison of ceftobiprole medocaril versus ceftazidime plus linezolid for the treatment of hospital-acquired pneumonia. Clin Infect Dis. 2014 Jul 1;59(1):51-61. doi: 10.1093/cid/ciu219. Epub 2014 Apr 9.
PubMed 24723282
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized Double-Blind Study Of Ceftobiprole Versus Linezolid Plus Ceftazidime In The Treatment Of Nosocomial Pneumonia
- ClinicalTrials.gov ID
- NCT00210964
- Acronym / sponsor ID
- CR005032
- Conditions
- Pneumonia
- Keywords
- Ceftobiprole medocaril, Nosocominal Pneumonia, Ventilator-Associated Pneumonia, Cephalosporins, Methicillin-Resistant Staphylococcus Aureus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 781 participants (actual)
- Lead sponsor
- Basilea PharmaceuticaIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 21 Sep 2005 (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 compare the clinical cure rate of ceftobiprole medocaril (the water-soluble prodrug [form] of ceftobiprole) referred to as ceftobiprole versus a comparator in the treatment of patients with nosocomial pneumonia.
Detailed description
Ceftobiprole medocaril (the water-soluble prodrug [form] of ceftobiprole), referred to as ceftobiprole is a cephalosporin antibiotic with anti-MRSA (Methicillin-Resistant Staphylococcus Aureus) activity. Ceftobiprole is not yet approved for the treatment of nosocomial (hospital-acquired) pneumonia. This is a randomized, double-blind, multicenter study of ceftobiprole versus a comparator (linezolid plus ceftazidime) to assess the effectiveness and safety of ceftobiprole in patients with nosocomial pneumonia. The patients will be randomized to receive ceftobiprole plus placebo or the comparator. The primary endpoint is the clinical cure rate of ceftobiprole at the test-of-cure visit. The patients will receive either ceftobiprole plus placebo or the comparator for 7 to 14 days (unless extended at discretion of medical monitor). Patient safety will be monitored throughout the study. In December 2006, this study (BAP00307) and another similar study (BAP00248, see NCT00229008) were amended (changed) to create 1 study (BAP00248/307).Therefore, the results reported for this study will be combined with the results reported for study BAP00248. Patients will receive either ceftobiprole plus placebo or a comparator by intravenous infusion for 7 to 14 days (unless extended at discretion of medical monitor).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Drug: ceftobiprole plus placeboceftobiprole plus placebo ceftobiprole 500 mg every 8 hours as a 120 minute intravenous infusion and placebo administered every 12 hours as a 60-minute intravenous infusion for 7 to 14 days |
| 002 | Active comparator | Drug: linezolid plus ceftazidimelinezolid plus ceftazidime linezolid 600 mg every 12 hours as a 60-minute intravenous infusion plus ceftazidime 2 g every 8 hours as a 120-minute intravenous infusion for 7 to 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients suffering from nosocomial pneumonia or ventilator-associated pneumonia
- Female patients must be postmenopausal for at least 1 year, surgically sterile, or practicing an effective method of birth control, before entry and throughout the study, and have a negative serum or urine pregnancy test at the screening
Key exclusion criteria (4 listed)
- Known or suspected hypersensitivity to any related antibiotic medications
- Any known or suspected condition or concurrent treatment that would be contraindicated by the prescribing information
- Treatment with any investigational drug within 30 days before enrollment
- Prior enrollment to this study
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 plus placeboceftobiprole 500 mg every 8 hours as a 120 minute intravenous infusion and placebo administered every 12 hours as a 60-minute intravenous infusion for 7 to 14 days | Drug | 001 |
| linezolid plus ceftazidimelinezolid 600 mg every 12 hours as a 60-minute intravenous infusion plus ceftazidime 2 g every 8 hours as a 120-minute intravenous infusion for 7 to 14 days | Drug | 002 |
Primary outcome
Clinical cure rate (the ratio of the number of clinically cured patients to the total number of patients in the population)
Time frame: 7 to 14 days after the end-of-therapy (EOT)
4 secondary outcomes
Microbiological eradication rate
Time frame: At the TOC visit defined as 7-14 days after the EOT
Clinical cure rate
Time frame: At the late follow-up (LFU) visit defined as 28 to 35 days after the EOT
Microbiological eradication rates
Time frame: At the LFU visit defined as 28 to 35 days after the EOT
Pneumonia-specific mortality rates
Time frame: Within 30 days after randomization
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 3 Sep 2012.
- Derived from this study: PubMed 41251370Hahn MM, Anderson MS, Snyder M, Du W, Chou Y-L, McCracken B, Smart JI, Litherland K, Keech S, von Siebenthal F, Jones M, Henning LN. Pharmacokinetic modeling and efficacy of ceftobiprole medocaril against pneumonic tularemia in cynomolgus macaques. Antimicrob Agents Chemother. 2025 Dec 10;69(12):e0127825. doi: 10.1128/aac.01278-25. Epub 2025 Nov 18.
- Derived from this study: PubMed 34155899Huang H, Gao L, Engelhardt M, Saulay M, Hamed K. A post hoc analysis of two Phase III trials showing the efficacy and tolerability of ceftobiprole in East Asian patients. Future Microbiol. 2021 Jul;16:783-796. doi: 10.2217/fmb-2021-0121. Epub 2021 Jun 22.
- Derived from this study: PubMed 33960817Welte T, Scheeren TW, Overcash JS, Saulay M, Engelhardt M, Hamed K. Efficacy and safety of ceftobiprole in patients aged 65 years or older: a post hoc analysis of three Phase III studies. Future Microbiol. 2021 May;16:543-555. doi: 10.2217/fmb-2021-0042. Epub 2021 May 7.
- Derived from this study: PubMed 30808293Scheeren TWL, Welte T, Saulay M, Engelhardt M, Santerre-Henriksen A, Hamed K. Early improvement in severely ill patients with pneumonia treated with ceftobiprole: a retrospective analysis of two major trials. BMC Infect Dis. 2019 Feb 26;19(1):195. doi: 10.1186/s12879-019-3820-y.
- Derived from this study: PubMed 24723282Awad SS, Rodriguez AH, Chuang YC, Marjanek Z, Pareigis AJ, Reis G, Scheeren TW, Sanchez AS, Zhou X, Saulay M, Engelhardt M. A phase 3 randomized double-blind comparison of ceftobiprole medocaril versus ceftazidime plus linezolid for the treatment of hospital-acquired pneumonia. Clin Infect Dis. 2014 Jul 1;59(1):51-61. doi: 10.1093/cid/ciu219. Epub 2014 Apr 9.
- Ceftobiprole in Hospital Acquired PneumoniaLink provided by the sponsor.
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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.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing linezolid plus ceftazidime in people with Pneumonia, 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 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: finished, as of the sponsor's last update on 3 Sep 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Clinical cure rate (the ratio of the number of clinically cured patients to the total number of patients in the population) (time frame: 7 to 14 days after the end-of-therapy (EOT)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00210964, which also lists 5 linked publications.
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 3 Sep 2012.