Status:

UNKNOWN

The Population Pharmacokinetics Study of Tigecycline and Pharmacokinetics- Pharmacodynamics Index in Patients With Carbapenem Resistant Enterobacteriaceae Bloodstream Infection

Lead Sponsor:

Phramongkutklao College of Medicine and Hospital

Collaborating Sponsors:

Silpakorn University

Conditions:

Carbapenem-resistant Enterobacteriaceae

Eligibility:

All Genders

20+ years

Phase:

NA

Brief Summary

Carbapenem-resistant Enterobacteriaceae (CRE) are an urgent global public health problem. Patients who were infected caused by CRE bloodstream infection were high mortality up to 40%. The National Ant...

Detailed Description

Carbapenem-resistant Enterobacteriaceae (CRE) are an urgent global public health problem. Patients who were infected caused by CRE bloodstream infection were high mortality up to 40%. The National Ant...

Eligibility Criteria

Inclusion

  • 20 years and older who were admitted at Phramongkutklao Hospital
  • Patients who were diagnosed bloodstream infection with CRE and who were sepsis or septic shock
  • Patients who received tigecycline loading dose 200 mg infusion for 1 hour and following maintenance dose 100 mg every 12 h infusion for 1 hour at least 48 hours and grant for blood collection

Exclusion

  • Pregnancy or Breastfeeding
  • Patients who cannot tolerant to the toxicity of tigecycline for example hypersensitivity to tigecycline or any component of the formulation
  • Patients who were infected with more than one isolated in blood culture at the same time

Key Trial Info

Start Date :

September 17 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 30 2025

Estimated Enrollment :

72 Patients enrolled

Trial Details

Trial ID

NCT06049771

Start Date

September 17 2023

End Date

June 30 2025

Last Update

September 22 2023

Active Locations (1)

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1

Phramongkutklao Hospital

Ratchathewi, Bangkok, Thailand, 10400