A study to assess the efficacy of high-loading dose regimen of teicoplanin in pediatric patients
Not Applicable
Recruiting
- Conditions
- Methicillin-resistant Staphylococcus aureus infection
- Registration Number
- JPRN-UMIN000027535
- Lead Sponsor
- Department of Pediatrics, Graduate School of Medical Sciences, Kyushu University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 42
Inclusion Criteria
Not provided
Exclusion Criteria
1. Patients with renal impairment (serum creatinine is 1.5 times higher than upper limit of normal) and hepatic dysfunction (AST or ALT is 2.5 times higher than upper limit of normal) before teicoplanin treatment 2. Patients with past histories of hypersensitivity reaction against teicoplanin 3. Patients with previous teicoplanin treatment during the previous 7 days 4. Patients with inadequate medical conditions determined by the study director or researchers
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of achieving target serum trough concentration of teicoplanin (more than 15 mg/L) in pediatric patients on the day 3 or 4 of treatment
- Secondary Outcome Measures
Name Time Method 1. Rate of achieving target serum trough concentration of teicoplanin (more than 10 mg/L) in pediatric patients on the day 3 or 4 of treatment 2. Incidence of hepatic dysfunction and renal impairment during teicoplanin treatment (AST, ALT, serum creatinine) 3. Resolution of clinically significant signs and symptoms, and mortality on the 4th day of teicoplanin treatment and the day of teicoplanin treatment completion in patients with Methicillin-resistant Staphylococcus aureus (MRSA) infection 4. Duration of fever, and incidence of addition or switching of other anti-MRSA drugs in patients with MRSA infection 5. Duration of bacteremia in patients with MRSA sepsis 6. Relationships between age and concentration (mg/L) /cumulative loading dose per body weight (mg/kg) (C/D) ratio, serum creatinine level and C/D ratio, and estimated glomerular filtration ratio and C/D ratio