Pharmacokinetics of intravenous tigecycline in pediatric patients
- Conditions
- PK parameters of tigecycline in pediatric patients with multidrug-resistant infection receiving intravenous tigecyclineTigecycline, Pharmacokinetics, Multidrug-resistant resistant organisms, Pediatrics
- Registration Number
- TCTR20240319006
- Lead Sponsor
- Ratchadapisek Sompoch Research Fund
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
1. Patients aged 1 month to 8 years on the day of enrollment
2. Receiving intravenous tigecycline at least 6 doses prescribed by their primary physicians for treating MDROs infection
3. Adequate vascular access to enable blood collection
Exclusion Criteria
1. Body weight of less than 3 kg
2. Tetracycline or tigecycline allergy
3.Patients with a Child-Pugh Score class C, which requires an adjustment to the tigecycline dosage
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method steady-state PK parameters At predose, immediately after the end of infusion, and then approximately 1, 2, 4, 6, 8, and 12 (before the next dose given) h after the start of tigecycline administration High-performance liquid chromatography method,Appropriate dose of intravenous tigecycline At steady-state PK parameters at least 6 doses of tigecycline intravenous infusion PK-PD target achievement evaluation
- Secondary Outcome Measures
Name Time Method Proportions of patients achieving the desired PK-PD index will be reported as counts with percentages. At steady-state PK parameters at least 6 doses of tigecycline intravenous infusion Numbers and percentages by a simple calculation,Treatment outcomes 30 days 30-day mortality rate,Microbiological outcomes 48-72 hours after receiving tigecycline intravenous infusion Eradication, Persistence