Clinical trial NCT00210964: Ceftobiprole in Hospital Acquired Pneumonia
Official title: A Phase III Randomized Double-Blind Study Of Ceftobiprole Versus Linezolid Plus Ceftazidime In The Treatment Of Nosocomial Pneumonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumonia
Keywords: Ceftobiprole medocaril
Nosocominal Pneumonia
Ventilator-Associated Pneumonia
Cephalosporins
Methicillin-Resistant Staphylococcus Aureus
Lead sponsor: Basilea Pharmaceutica
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 781
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Clinical cure rate (the ratio of the number of clinically cured patients to the total number of patients in the population)
timeFrame: 7 to 14 days after the end-of-therapy (EOT)
Secondary outcomes:
measure: Microbiological eradication rate
timeFrame: At the TOC visit defined as 7-14 days after the EOT
measure: Clinical cure rate
timeFrame: At the late follow-up (LFU) visit defined as 28 to 35 days after the EOT
measure: Microbiological eradication rates
timeFrame: At the LFU visit defined as 28 to 35 days after the EOT
measure: Pneumonia-specific mortality rates
timeFrame: Within 30 days after randomization
Other outcomes:
Locations:
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.