PK parameters of sulbactam in pediatric patients with proven or suspected multidrug resistance A. baumannii infection receiving intravenous sulbactam Sulbactam, TDM, pharmacokinetics, A. baumannnii, pediatrics
Conditions
Interventions
Children were prescribed sulbactam intravenous infusion for confirmed or suspected A. baumannii infection.
Treatment
1 month children to 18 year children were prescribed sulbactam intravenous infusion
Sponsors
Ratchadapisek Sompoch Research Fund
Fundamental Fund
Eligibility
Sex/Gender
All
Age
1 Months to 18 Years
Inclusion criteria
Inclusion criteria: 1. Inclusion criteria (for therapeutic drug monitoring) 1.1 Patients aged from 1 month to 18 years at the day of enrollment. 1.2 Body weight from 3 kg. 1.3 Receiving intravenous sulbactam for the treatment of proven or suspected A. baumannii infections. 1.4 Adequate vascular access to enable blood collection 2. Inclusion criteria (for the pharmacokinetic drug study) 2.1 Patients aged from 1-12 years at the day of enrollment. 2.2 Body weight from 10 kg. 2.3 Receiving intravenous sulbactam for the treatment of proven or suspected A. baumannii infections. 2.4 Adequate vascular access to enable blood collection.
Exclusion criteria
Exclusion criteria: 1. Estimated glomerular filtration rate of less than 30 mL/min/1.73 m2, which requires sulbactam dose adjustment. 2. Receiving any renal replacement therapy (RRT) or extracorporeal membrane oxygenation (ECMO) 3. Beta-lactams or sulbactam allergy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK parameters At pre-dose, 30min, 1hour, 2hours, 4hours, 6hours and 8 hours after 3-5th dose of sulbactam High-performance liquid chromatography method,The steady-state Cmid (50% fT) and Ctrough (100% fT) At 4hours and 8 hours after 3-5th dose of sulbactam High-performance liquid chromatography method | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportions of patients who achieved targeted PK-PD indices 3-5th doses after receiving sulbactam intravenous infusion Numbers and percentages by a simple calculation,Treatment Outcomes 30 days 30-day mortality rate,Microbiological outcomes 48-72 hours after receiving sulbactam intravenous infusion Eradication, Persistence | — |
Countries
Thailand
Contacts
Public ContactKankamol Charoenwong
Faculty of Medicine, Chulalongkorn University
Outcome results
None listed