Community-acquired Bacterial Pneumonia MedDRA version: 14.1 Level: PT Classification code 10035664 Term: Pneumonia System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1 Level: LLT Classification code 10004051 Term: Bacterial pneumonia, unspecified System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1 Level: PT Classification code 10060946 Term: Pneumonia bacterial System Organ Class: 10021881 - Infections and infestations MedDRA version: 14
Conditions
Interventions
Product Name: Ceftaroline fosamil
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: Ceftaroline Fosamil
CAS Number: 229016-73-3
Other descriptive name: PPI-090
Sponsors
Cerexa, Inc. (subsidary of Forest Laboratories)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed consent in writing from parent(s) or other legally acceptable representative(s) and informed assent from subject (if age appropriate according to local requirements). 2. Male or female 2 months to 38.0°C) or hypothermia (temperature 15,000 white blood cells [WBC]/mm3) - >15% immature neutrophils (bands) regardless of total peripheral WBC - Leukopenia (=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Documented history of any hypersensitivity or allergic reaction to any ß-lactam antimicrobial. 2. Confirmed or suspected infection with a pathogen known to be resistant to ceftriaxone (eg, Pseudomonas aeruginosa, methicillin-resistant Staphylococcus aureus [MRSA]) or known infection at baseline with a sole atypical organism (eg, Mycoplasma pneumoniae, Chlamydophila pneumoniae, Chlamydia trachomatis, Legionella pneumophila). Epidemiological clues to potential MRSA infection include necrotizing pneumonia, existence of an ongoing local MRSA infection outbreak, known skin colonization with MRSA, recent invasive MRSA infection, and recent influenza. Subjects with risk factors for MRSA infection who have predominance of gram-positive cocci in clusters on sputum Gram stain should also be excluded. 3. Confirmed or suspected respiratory tract infection attributable to sources other than community-acquired bacterial pathogens (eg, ventilator-associated pneumonia; hospital-acquired pneumonia [occurring 48 hours or more after admission, which was not incubating at the time of admission (Niederman, 1996; Tablan et al, 2004)]; visible/gross aspiration pneumonia; suspected sole viral [eg, respiratory syncytial virus], fungal, Mycobacterium tuberculosis infection of the lung); chronic lung disease or neurologic disease preventing normal clearance of secretions. 4. Non-infectious causes of pulmonary infiltrates (eg, cystic fibrosis, chemical pneumonitis from aspiration, hypersensitivity pneumonia) on chest radiography. 5. More than 24 hours of any potentially effective systemic antibacterial therapy for CABP within 96 hours before randomization. EXCEPTIONS: a) Microbiological or clinical treatment failure with an antibiotic other than IV study drugs that was administered for at least 48 hours. Failure must be confirmed by either a microbiological laboratory report or documented worsening clinical signs or symptoms. b) Low dose tetracycline derivative for acne (eg, doxycycline 50 mg q12h) 6. Requirement for any potentially effective concomitant systemic antibacterial therapy 7. Requirement for more than 10 days of systemic corticosteroid therapy (any dose) 8. History of seizures, excluding febrile seizure of childhood. 9. Creatinine clearance 3 times the upper limit of normal (× ULN) or total bilirubin level > 2 × ULN - Known acute viral hepatitis - Neutropenia (< 500 neutrophils/mm3) - Thrombocytopenia (< 60,000 platelets/mm3) - If human immunodeficiency virus (HIV)-positive, has CD4 count < 250 cells/mm3 at the last measurement or history of AIDS-defining illness - Bone marrow ablative therapy, including bone marrow transplantation, within the last 12 months - Bone marrow or solid organ recipients who have had an episode of graft versus host disease or acute rejection episode, respectively, within the last 6 months - Severe combined immunodeficiency disorder (SCID) 12. Evidence of immediately life-threatening disease, progressively fatal disease, or life expectancy of 3 months or less. 13. Females who are currently pregnant or breastfeedi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary objective is to evaluate the safety and tolerability of ceftaroline versus ceftriaxone in pediatric subjects ages 2 months to < 18 years with CABP requiring hospitalization.;Timepoint(s) of evaluation of this end point: • Adverse events: AEs, SAEs, deaths, & discontinuations due to AEs will be evaluated. Cephalosporin class effects & additional AEs (incl, but not limited to, seizures, Clostridium difficile-associated diarrhea, allergic reactions, hemolytic anemia, hepatic abnormalities, & changes in renal function) will be closely monitored at Treatment, EOIV, EOT, TOC, LFU. • Clinical: vital signs at Treatment, EOIV, EOT, TOC, LFU • Laboratory: CBC with differential (at TD7, EOIV, TOC), direct Coombs test (at TOC), and chemistry panel (at TD2 and 3, EOIV) ;Secondary Objective: • Evaluate the efficacy of ceftaroline versus ceftriaxone in pediatric subjects with CABP requiring hospitalization. • Evaluate the pharmacokinetics of ceftaroline in pediatric subjects ages 2 months to < 18 years with CABP requiring hospitalization.;Main Objective: The primary objective is to evaluate the safety and tolerability of ceftaroline versus ceftriaxone in pediatric subjects ages 2 months to < 18 years with CABP requiring hospitalization. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Evaluate the efficacy of ceftaroline versus ceftriaxone in pediatric subjects with CABP requiring hospitalization. 2. Evaluate the pharmacokinetics of ceftaroline in pediatric subjects ages 2 months to < 18 years with CABP requiring hospitalization. ;Timepoint(s) of evaluation of this end point: •Clinical response at Study Day 4 •Clinical stability at Study Day 4 •Clinical outcome at End-of-Intravenous Study Drug, EOT, and TOC •Clinical and microbiological outcomes •Clinical relapse at Late Follow-up •Emergent infections •Concentrations of ceftaroline fosamil, ceftaroline, and ceftaroline M1 in plasma •If available, concentrations of ceftaroline fosamil, ceftaroline, and ceftaroline M1 in cerebrospinal fluid | — |
Countries
Argentina, Brazil, Greece, Hungary, Poland, Spain, Ukraine, United States
Contacts
Public ContactExecutive Director, Reg Affairs
Cerexa, Inc. (subsidary of Forest Laboratories)
Outcome results
None listed