Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase III Randomized Double-Blind Study Of Ceftobiprole Versus Linezolid Plus Ceftazidime In The Treatment Of Nosocomial Pneumonia
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.


Options:
A: 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
B: Inclusion Criteria:

* Children aged 3 to 59 months with pneumonia and lower chest wall indrawing
* Ability to take orally
* Absence of radiological consolidation or effusion
* Informed consent by a legal guardian

Exclusion Criteria:

Children with any of the following conditions:

* Very severe pneumonia/disease
* Respiratory rate \> 70/min
* Persistent vomiting
* Known prior episodes of asthma, or, three or more prior episodes of wheezing
* LCI that resolves after three doses of bronchodilator therapy1
* Documented use of prior oral antibiotics for 48 hours
* Severe malnutrition (weight for height \< 3SD or kwashiorkor)
* Known penicillin or amoxicillin allergy
* Hospitalization in the last two weeks
* Known or clinically recognizable HIV, congenital cardiac or respiratory anomalies, chronic lung disease including bronchopulmonary dysplasia, neurological impairment that affects respiratory function, renal diseases, malignant or haematological diseases.
* Other diseases requiring antibiotic therapy at presentation, such as meningitis,dysentery, osteomyelitis, septic arthritis, evident tuberculosis, etc.
* Anaemia requiring blood transfusion
* Kerosene poisoning
* Measles in the last 15 days
* Previous inclusion in the study or already included in another study
* Living outside a pre-defined area
* Parental or caretaker refusal to participate in the study
C: Inclusion Criteria:

* Clinical signs of WHO-defined severe pneumonia
* Age 2 months to 59 months

Exclusion Criteria:

* Clinical signs of WHO-defined very severe pneumonia
* Clinical or laboratory diagnosis of meningitis
* Clinical diagnosis of severe malnutrition (marasmus/kwashiorkor)
* Clinical or laboratory diagnosis of severe anaemia requiring transfusion
* HIV-exposure on rapid HIV antibody test (only observational data will be collected from these patients)
* Elimination of signs of severe pneumonia in a child with wheeze after outpatient bronchodilator therapy
* Chronic condition that may underlie or contribute to a presentation with respiratory distress such as: known chronic renal or cardiac disease, presence of cerebral palsy predisposing child to aspiration/hypostatic pneumonia
* Established bronchiectasis or congenital abnormality of the lower respiratory tract
* Upper airway obstruction producing stridor
* Admission from outpatient clinic specifically for treatment of TB
* Referral from another inpatient facility following treatment with injectable antibiotics for more than 24 hours or because the initial regimen is considered to have failed
* Documented history of \>48hours treatment with oral amoxicillin
* Failure to obtain informed consent
* Penicillin allergy
D: Inclusion Criteria:

* Male of female aged 3 months to \< 18 years with a body weight of at least 5 kg
* Diagnosis of either hospital-acquired pneumonia or community-acquired pneumonia requiring hospitalization and administration of IV antibiotic therapy
* New or progressive imaging findings consistent with bacterial pneumonia
* Requirement for IV antibacterial treatment for pneumonia
* Other inclusion criteria may apply

Exclusion Criteria:

* Known resistance of the causative pathogen to ceftobiprole or IV standard-of-care cephalosporin treatment (± vancomycin)
* On mechanical ventilation
* Chest trauma with severe lung contusion or flail chest
* Acute respiratory distress syndrome
* Empyema or lung abscess
* Anatomical bronchial obstruction
* Active or currently treated pulmonary tuberculosis
* Atypical bacterial pneumonia, or viral pneumonia without bacterial superinfection, or need for antibiotic coverage with a macrolide
* Pertussis, chemical pneumonitis, or cystic fibrosis
* Severe immunodeficiency
* Significant laboratory abnormalities including: Hematocrit \<20%; absolute neutrophil count \<0.5x10⁹/L; platelet count \<50x10⁹/L; alanine aminotransferase, aspartate aminotransferase, or bilirubin \>5 times the age-specific upper limit of normal;
* Creatinine clearance \<50 mL/min/1.73 m²
* Use of systemic antimicrobial therapy for more than 24 hours in the 48 hours before randomization
* History of a previous clinically-relevant hypersensitivity or serious adverse reaction to beta lactam antibiotics or to vancomycin
* Poorly controlled seizure disorder
* Other exclusion criteria may apply

Answer: A