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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