Efficacy and Safety of Colistin for Therapy of Infections Caused by ESBL Producing K.Pneumoniae or E.Coli

Overview

In patients with documented ESBL-producing E.coli and Klebsiella pneumoniae will be allocated to receive colistin or conventional antibiotic regimen.

Full Title of Study: “Efficacy and Safety of Colistin for Therapy of Infections Caused by Extended Spectrum Beta-Lactamase(ESBL) Producing Klebsiella Pneumoniae or Escherichia Coli”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)

Detailed Description

In patients with documented ESBL-producing E.coli and Klebsiella pneumoniae will be allocated to receive colistin or conventional antibiotic regimen.The primary outcome is clinical response and secondary outcomes are microbiological response and adverse events.

Interventions

  • Drug: Colistin

Clinical Trial Outcome Measures

Primary Measures

  • Clinical response

Secondary Measures

  • Microbiological response

Participating in This Clinical Trial

Inclusion Criteria

  • Age > 18 yr. – Hospitalized to Siriraj Hospital – Infections with ESBL-producing E.coli or K.pneumoniae – Consent informed consent Exclusion Criteria:

  • Pregnancy or lactating mother – Colistin allergy – Neurologic diseases

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mahidol University
  • Overall Official(s)
    • Visanu Thamlikitkul, MD, Principal Investigator, Faculty of Medicine Siriraj Hospital
  • Overall Contact(s)
    • Visanu Thamlikitkul, MD, 662 419 7000, sivth@mahidol.ac.th

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