Pharmacokinetics and Therapeutic Drug Monitoring of Intravenous Sulbactam in Pediatrics

• Conditions: 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

• Registration Number: TCTR20221114001
• Lead Sponsor: Ratchadapisek Sompoch Research Fund

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-14
• Study Completion: 2024-04-04
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 62

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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