Ceftobiprole in Hospital Acquired Pneumonia

NCT00210964 | Completed Phase 3 DMC

• 2 other identifiers: CR005032BAP00307
• Study Type: interventional
• Target: 781
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pneumonia

Keywords

Ceftobiprole medocaril; Nosocominal Pneumonia; Ventilator-Associated Pneumonia; Cephalosporins; Methicillin-Resistant Staphylococcus Aureus

Outcome Measures

Primary Outcomes (1)

• Clinical cure rate (the ratio of the number of clinically cured patients to the total number of patients in the population)

  7 to 14 days after the end-of-therapy (EOT)

Secondary Outcomes (4)

• Microbiological eradication rate

  At the TOC visit defined as 7-14 days after the EOT

• Clinical cure rate

  At the late follow-up (LFU) visit defined as 28 to 35 days after the EOT

• Microbiological eradication rates

  At the LFU visit defined as 28 to 35 days after the EOT

• Pneumonia-specific mortality rates

  Within 30 days after randomization

Study Arms (2)

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

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

Drug: linezolid plus ceftazidime

Interventions

ceftobiprole plus placebo DRUG

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

001

linezolid plus ceftazidime DRUG

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

002

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Basilea Pharmaceutica: lead

Related Publications (4)

• 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.

  PMID: 34155899 DERIVED

• 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.

  PMID: 33960817 DERIVED

• 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.

  PMID: 30808293 DERIVED

• 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.

  PMID: 24723282 DERIVED

Related Links

• Ceftobiprole in Hospital Acquired Pneumonia

MeSH Terms

Conditions

Pneumonia; Pneumonia, Ventilator-Associated

Interventions

ceftobiprole; Linezolid; Ceftazidime

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Healthcare-Associated Pneumonia; Cross Infection; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Oxazolidinones; Oxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cephaloridine; Cephalosporins; beta-Lactams; Lactams; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: April 1, 2005
• Primary Completion: May 1, 2007
• Study Completion: May 1, 2007
• Last Updated: September 3, 2012

Record last verified: 2012-08