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Clinical Trials/TCTR20221114001
TCTR20221114001
Not yet recruiting
Not Applicable

Pharmacokinetics and Therapeutic Drug Monitoring of Intravenous Sulbactam in Pediatrics

Ratchadapisek Sompoch Research Fund0 sites62 target enrollmentNovember 14, 2022
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ConditionsPK parameters of sulbactam in pediatric patients with proven or suspected multidrug resistance A. baumannii infection receiving intravenous sulbactamSulbactam, TDM, pharmacokinetics, A. baumannnii, pediatrics

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
PK parameters of sulbactam in pediatric patients with proven or suspected multidrug resistance A. baumannii infection receiving intravenous sulbactam
Sponsor
Ratchadapisek Sompoch Research Fund
Enrollment
62
Status
Not yet recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 14, 2022
End Date
April 4, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Ratchadapisek Sompoch Research Fund

Eligibility 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

  • •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

Outcomes

Primary Outcomes

Not specified

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