PneumoniaPhase 3NCT00229008

Ceftobiprole in Hospital Acquired Pneumonia

A Phase 3 study testing linezolid plus ceftazidime in people with Pneumonia, run by Basilea Pharmaceutica.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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: 106 participants
Where: No sites listed yet
Study dates: Nov 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 3 Randomized Double-Blind Study Of Ceftobiprole Medocaril Versus Linezolid Plus Ceftazidime In The Treatment Of 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 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 (BAP00248) and another similar study (BAP00307, see NCT00210964) 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, Nosocomial Pneumonia, Ventilator-Associated Pneumonia, Cephalosporins, Methicillin-Resistant Staphylococcus Aureus
Medical subject headings: Pneumonia, Healthcare-Associated 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 groups in NCT00229008
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 the randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2005May 2007

First posted29 Sep 2005 (estimated)
Study startNov 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: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 106 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00229008
Sponsor's protocol ID: CR005140
Other IDs: BAP00248
Status last verified: Aug 2012
First submitted: 27 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 41251370
Huang 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 34155899
Welte 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 33960817
Scheeren 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 30808293
Awad 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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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 3 Randomized Double-Blind Study Of Ceftobiprole Medocaril Versus Linezolid Plus Ceftazidime In The Treatment Of Nosocomial Pneumonia
ClinicalTrials.gov ID: NCT00229008
Acronym / sponsor ID: CR005140
Conditions: Pneumonia
Keywords: Ceftobiprole medocaril, Nosocomial Pneumonia, Ventilator-Associated Pneumonia, Cephalosporins, Methicillin-Resistant Staphylococcus Aureus
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 106 participants (actual)
Lead sponsor: Basilea PharmaceuticaIndustry (pharma, biotech, devices)
Study start: Nov 2005
Primary completion: May 2007 (actual)
Study completion: May 2007 (actual)
First posted: 29 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
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 the 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 NCT00229008, 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.