bacterial pneumonia
Conditions
Interventions
tebipenem pivoxil 6mg/kg twice daily orally
ampicillin 30~40mg/kg three times daily intravenously or sulbactam/ampicillin 30~50mg/kg three times daily intravenously
Sponsors
Yokohama Pediatric Infectious Disease Research Conference
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Hospitalized patients who are diagnosed as community-acquired bacterial pneumonia are eligible. 2) Both of the following conditions must be met: - WBC count over 12,000/uL or CRP level over 2 mg/dL. - Patients with a moderate form of the disease according to the standard criteria described in the 2011 guidelines.
Exclusion criteria
Exclusion criteria: 1)Patients with other infectious foci who are potentially unresponsive to treatment with orally administered medication. 2)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)Patients with convulsive disorders, such as epilepsy, as an underlying disease. 4)Patients with a lipid metabolism disorder or congenital carnitine deficiency. 5)Patients with a history of allergy to beta-lactam antibiotics (e.g.,carbapenems, penicillin, and cephem). 6)Patients in whom tebipenem pivoxil is contraindicated. 7)Patients who have received pivalate-conjugated antibiotics more than 1 week within 2 weeks before admission. 8)Patients who have received tebipenem pivoxil or control antibiotics just before admission. 9)Patients who have received other antibiotics and exhibited improvements. 10)Patients who are presenting with concurrent asthma attack. 11)Patients who are definitively diagnosed as Mycoplasmal pneumonia or Chlamydial penumina 12)Patients deemed inappropriate for this study by the attending physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical efficacy at the end of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Time to defervescence after the first administration 2)Recrudescence of pneumonia within 1 week after the end of treatment 3)Adverse events during treatment | — |
Countries
Japan
Contacts
Public ContactAtsuo Sato
Yokohama Rosai Hosipital, Japan Labour Health and Welfare Organization Department of Pediatrics
Outcome results
None listed