Bacterial Pneumonia MedDRA version: 14.1 Level: LLT Classification code 10004051 Term: Bacterial pneumonia, unspecified System Organ Class: 10021881 - Infections and infestations
Conditions
Sponsors
Janssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 - Have new or progressive radiographic infiltrate(s) (alveolar, lobar, or consolidation) consistent with a bacterial pneumonia that is not related to cardiac or other disease processes. (Note: subjects with clinically significant pleural effusions may be included if an empyema has been ruled out by a diagnostic sampling of pleural fluid. Chest X-rays obtained within 48 hours before the start of the infusion of the first dose of IV study drug therapy are acceptable for the screening examination. A computed tomography (CT) scan/magnetic resonance imaging (MRI) may be used to supplement a chest X-ray if the chest X-ray is not sufficiently interpretable). 2 - Have a clinical presentation compatible with bacterial pneumonia with ALL of the following: o Fever (oral temperature >38.0C, tympanic temperature >38.3C, or rectal or core temperature >38.8C) or hypothermia (rectal or core temperature or = 15,000 cells/µL OR > or = 15% immature neutrophils, regardless of the total peripheral white cell count OR neutrophil count >1.2 times (x) the upper limit of normal (ULN); OR leucopenia with total WBC count or = 50 breaths/minute for ages > or = 3 months to or = 40 breaths/minute for ages >12 months to or = 20 breaths/minute for ages >5 years of age OR apnea in infants or = 48 hours before being diagnosed with pneumonia. Severe community-acquired pneumonia: Subjects with severe CAP must have pneumonia that is neither NP or VAP and must have at least ONE of the following risk factors for more severe disease or infection with a less susceptible pathogen: – a mild to moderately immunocompromised condition including but not limited to diabetes or other metabolic disorder associated with immunosuppression, asplenia, sickle cell disease, mild to moderate neutropenia (ANC of 500 – 1500 cells/mm3), HIV infection not requiring Pneumocystis jirovicei prophylaxis, antibody deficiency syndromes not requiring chronic immunoglobulin replacement therapy, T-cell deficiencies not requiring prophylactic antibiotics or other chronic therapy for the immunodeficiency, phagocytic disorders, and receipt of non-inhaled corticosteroid therapy equivalent to <1 mg/kg of prednisone daily for 14 or more days during the 30 days before randomization, – a documented tracheoesophageal
Exclusion criteria
Exclusion criteria: 1 - Have a history of hypersensitivity reactions to carbapenems, cephalosporins, penicillins, or other ß-lactam antibiotics. Note: Subjects with a history of mild non-urticarial skin rash temporally related to but considered not associated with the previous use of ß-lactam antibiotics are permitted to enroll in the study. For such subjects, there must be a description of the rash and documentation by the investigator that upon review of the history it is his/her opinion that the rash was unlikely due to any of the above-mentioned classes of drugs for the subject to qualify for inclusion in the study. 2 - Concomitant infection including but not limited to suspected or confirmed meningitis, or other CNS infection, requiring systemic antibiotic or antifungal therapy at the time of randomization. (Clarification: possible bacteremia with a presumed respiratory pathogen is acceptable). 3 - Have received more than 24 hours of systemic antibacterial therapy in the 48 hours before the start of the infusion of the first dose of IV study drug therapy. 4 - Known presence at baseline of Stenotrophomonas maltophilia or Burkholderia cepacia pulmonary infection 5 - Known at the time of randomization to have mono-microbial pneumonia caused by a single pathogen that is nonsusceptible to doripenem or cefepime, including but not limited to MRSA or atypical bacteria. 6 - Have acute respiratory distress syndrome (defined by either diffuse bilateral radiographic infiltrates and/or a PaO2 to fraction of inspired oxygen (FiO2) ratio of <200) 7 - Acute or chronic renal insufficiency with a baseline CLCR <60 mL/minute or requires dialysis therapy for any reason. 8 - Are profoundly immunodeficient and require prophylactic antimicrobial therapy to prevent infection with Pneumocystis jirovicei, Toxoplasma gondii, or herpes viruses, and/or required chronic or intermittent immunoglobulin replacement therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to establish the safety and tolerability of doripenem compared with that of cefepime in hospitalized children 3 months to <18 years of age with suspected bacterial pneumonia including NP (Nosocomial Pneumonia), VAP (Ventilator-Assiociated Pneumonia), and severe CAP (Community-Acquired Pneumonia).;Secondary Objective: The secondary objectives are: •To determine the clinical cure rate of doripenem compared with that of cefepime at the test-of-cure (TOC) visit •To determine the clinical improvement rate of doripenem compared with that of cefepime at the end-of-treatment for IV study drug therapy (EIV) visit •To determine the clinical relapse rate of doripenem compared with that of cefepime at the late follow-up (LFU) visit •To characterize the pharmacokinetics of doripenem in hospitalized children with pneumonia based on a sparse pharmacokinetic sampling scheme ;Primary end point(s): 1 - Changes in adverse events 2 - Clinical laboratory tests 3 - Vital signs measurements;Timepoint(s) of evaluation of this end point: 1 - Baseline up to 42 days after the last dose of study drug 2 - Baseline up to 42 days after the last dose of study drug 3 - Baseline up to 42 days after the last dose of study drug | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1 - To determine the clinical cure rate of doripenem compared with that of cefepime at the test of cure (TOC) visit 2 - To determine the clinical improvement rate of doripenem compared with that of cefepime at the end of treatment for IV study drug therapy (EIV) visit 3 - To determine the clinical relapse rate of doripenem compared with that of cefepime at the late follow-up (LFU) visit 4 - To characterize the pharmacokinetics of doripenem in hospitalized children with pneumonia based on a sparse pharmacokinetic sampling scheme;Timepoint(s) of evaluation of this end point: 1 - 7 to 14 days after the last dose of iv study drug including oral antibiotic therapy 2 - Within 24 hours after completion of the last dose of iv study drug 3 - 28 to 42 days after the last dose of iv study drug including oral antibiotic therapy 4 - 1, 2, 4 and 6 hours after the 4th, 5th, 6th, or 7th dose administrations of doripenem/doripenem placebo | — |
Countries
Argentina, Brazil, Colombia, India, Latvia, Lithuania, Mexico, Panama, Poland, Uganda, Ukraine
Contacts
Public ContactClinical Registry Group
Janssen- Cilag International NV
Outcome results
None listed