Pediatric bacterial pneumonia
Conditions
Interventions
None listed
Sponsors
Department of Pediatrics, Kawasaki Medical School
Keio University School of Medicine Niigata University Medical and Dental Hospital Osaka Rosai Hospital Sotobo Children'
s Clinic, Medical Corporation Shigyo-no-kai Kurosaki Children'
s Clinic etc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Outpatients and hospitalized patients are eligible. 2) All of the following conditions must be met: (1) Seven days or less after disease onset. (2) Presence of symptoms of respiratory infection, such as fever (over 37.5 degrees centigrade), cough, and expectorated sputum. (3) Images of new infiltration visible on the chest radiograph. (4) WBC count over 15,000/uL or CRP level over 4 mg/dL. 3) Pediatric patients with a moderate or mild form of the disease or with a risk of being infected by resistant bacteria according to the standard criteria described in the 2011 guidelines.
Exclusion criteria
Exclusion criteria: 1) Pediatric patients with other infectious foci who are potentially unresponsive to treatment with orally administered medication. 2) Pediatric patients in whom the efficacy and safety of the study drug is difficult to determine because of a progressive, complicated, or severe underlying disease believed to critically influence the onset of the infection, its clinical course, and therapeutic efficacy. 3) Pediatric patients with convulsive disorders, such as epilepsy, as an underlying disease. 4) Pediatric patients with a lipid metabolism disorder or congenital carnitine deficiency. 5) Pediatric patients with severe hepatic or renal dysfunction. To determine whether the pediatric patient is appropriate for this study, the attending physician must judge the child's condition on the basis of the following laboratory values: - Liver function values: AST (GOT) levels over 100 IU/L or ALT (GPT) levels over 100 IU/L. - Renal function values: BUN over 25 mg/dL or serum creatinine levels over 2.0 mg/dL. 6) Pediatric patients with poor oral ingestion or receiving parenteral feeding. 7) Pediatric patients with a history of allergy to beta-lactam antibiotics (e.g.,carbapenems, penicillin, and cephem). 8) Pediatric patients who have received other antibiotics and exhibited improvements. 9) Pediatric patients deemed inappropriate for this study by the attending physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| * Clinical effect 1 week after the end of treatment (i.e., determination of healing). * Adverse events occurring during the assessment period (with undeniable causality: side effects). | — |
Secondary
| Measure | Time frame |
|---|---|
| * Bacteriological efficacy at the end of treatment (day 3 to day 8). * Clinical efficacy 2 to 3 days after the initiation of treatment (day 3 to day 4) and at the end of treatment (day 3 to day 8). * Changes in body temperature and laboratory values. | — |
Countries
Japan
Contacts
Public ContactHiroto Akaike
Kawasaki Medical School Department of Pediatrics
Outcome results
None listed