Nosocomial Pneumonia MedDRA version: 9.1 Level: LLT Classification code 10052596 Term: Nosocomial pneumonia
Conditions
Interventions
Product Name: Ceftobiprole
Product Code: BAL5788 (Laboratory Code)
Pharmaceutical Form: Powder for solution for infusion
CAS Number: 252188-71-9
Current Sponsor code: BAL5788
Concentration unit: mg mi
Sponsors
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Written informed consent provided. Consent may be given for unconscious/ incapacitated subjects by their next of kin, guardian or legal representative according to local regulatory and ethical practice using a patient information sheet and informed consent form approved by the responsible Ethics Committee. 2) Male or female patients aged = 18 years. 3) Femal subjects must be postmenopausal (for at least 1 year), surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of of pregnancy), or practicing an effective method of birth control (e.g. prescription oral contraceptives, contraceptive injections or patch, intrauterine device, double-barrier method (e.g. condoms, diaphragm, or cervical cap with spermicidal foam, cream, or gel), male partner sterilization or, at the discretion of the investigator, abstinence), before entry and throughout the study; and have a negative serum or urine pregnancy test (depending on local regulations) at screning. 4) Subject suffering from NP or VAP defined as follows: Nosocomial Pneumonia (subject must have a, b, c and d) a) Clinical diagnosis of pneumonia after a minimum of 72 hours of hospitalization or in a chronic care facility Excemptions would include: - =48 to 1°C OR an oral temperature >38°C, a tympanic temperature >38.5°C, a rectal/core temperature >39°C, OR hypothermia, defined as a rectal/core body temperature of =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Female patients who are pregnant or lactating. 2) Known or suspected hypersensitivity to any related antiinfective (including beta-lactam antibiotics such as penicillins, cephalosporins, oxazolidinone, or monobactams) 3) Any known or suspected condition or concurrent treatment that would be contraindicated by the prescribing information for linezolid (any medicinal product which inhibits monoamine oxidases A or B, [e.g., phenelzine, isocarboxazid, selegiline, moclobemide] or within 2 weeks of taking any such medicinal product) or ceftazidime. Exception: Subjects with underlying conditions and/or on concomitant medications that might put them at risk from MAO inhibition can only be enrolled if they are hospitalized. 4) Known or suspected severe renal impairment, (calculated creatinine clearance [CrCl] 15% total body burn or any significant third degree burn). 10) Known to be HIV-positive with CD4 counts of =0.2x10exp9/L (=200 cells/mm³). Subjects with HIV and >0.2x10exp9/L [>200 cells/mm³] may be included). 11) Presence of myelosuppression or neutropenia (absolute neutrophil count [ANC] =0.5x10exp9/L [ 2 hours despite adequate fluid resuscitation, with evidence of hypoperfusion or need for sympathomimetic agents). 14) Subjects with either- known bronchial obstruction or a history of post-obstructive pneumonia (mild and moderate chronic obstructive pulmonary disease [COPD] patients are allowed) including primary lung cancer or another malignancy metastatic to the lungs, - cystic fibrosis, - lung abscess, - pleural effusion as a primary source of infection- active tuberculosis, or - subjects requiring antibiotic cover for aspiration pneumonia, atypical pneumonia (including Legionella pneumophila) or Pneumocystis jiroveci (carinii) pneumonia. Microbiological conditions that may interfere with assessment of efficacy: 15) Systemic antimicrobial therapy for > 24 hours in the 48 hours before enrollment Exceptions:Systemic antimicrobial therapy for more than 24 hours in the 48 hours before enrollment is permitted in case of any of the following: a) the infection is caused by microbiologically-confirmed pathogens that are resistant to the previous antimicrobial agents. b) the subject is clinically failing treatmen
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the noninferiority of ceftobiprole plus placebo compared with linezolid plus ceftazidime with respect to the clinical cure rate in subjects with nosocomial pneumonia (NP) at the test-of-cure (TOC) visit.;Secondary Objective: - To compare the microbiological eradication rate following treatment with ceftobiprole plus placebo with linezolid plus ceftazidime in subjects with NP at the TOC visit. - To compare the clinical cure rate and microbiological eradication rate following treatment with ceftobiprole plus placebo with linezolid plus ceftazidime in subjects with NP at the late follow-up (LFU) visit. - To compare the 30-day pneumonia-specific mortality rates following treatment with ceftobiprole plus placebo with linezolid plus ceftazidime in subject with NP.;Primary end point(s): Clinical cure rate, defined as the ratio of the number of clinically cured subjects to the total number of subjects in the population at TOC visit. | — |
Countries
Hungary, Latvia, Lithuania, Spain, United Kingdom
Outcome results
None listed