Study of the clinical efficacy and number of days of tebipenem pivoxil administration for the treatment of pediatric bacterial pneumonia.
- Conditions
- Pediatric bacterial pneumonia
- Registration Number
- JPRN-UMIN000010144
- Lead Sponsor
- Department of Pediatrics, Kawasaki Medical School
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 100
Not provided
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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method * 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 Outcome Measures
Name Time Method * 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.