A study to assess the efficacy of high-loading dose regimen of teicoplanin in pediatric patients

A study to assess the efficacy of high-loading dose regimen of teicoplanin in pediatric patients - A study to assess the efficacy of high-loading dose regimen of teicoplanin in pediatric patients

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000027535

Enrollment

Registered

2017-06-01

Start date

2017-06-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Methicillin-resistant Staphylococcus aureus infection

Interventions

1. Teicoplanin (15 mg/kg every 12 hours for 3 loading doses followed by 10 mg/kg every 24 hours) is infused intravenously over 1 hour. 2. Serum samples for teicoplanin trough level are obtained just

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Inpatients at the Department of Pediatrics, Kyushu University Hospital 2. Patients receiving teicoplanin treatment for diagnosed or suspected Methicillin-resistant Staphylococcus aureus infection 3. Patients whose written informed consent has been obtained (from them or from their parents)

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactShunsuke Kanno

Graduate School of Medical Sciences, Kyushu University Department of Pediatrics

kannos@pediatr.med.kyushu-u.ac.jp092-642-5421

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026