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

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00300560

Enrollment

152

Registered

2006-03-09

Start date

2006-02-28

Completion date

2006-12-31

Last updated

2006-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infections

Keywords

ESBL-producing E.coli Infections, ESBL-producing Klebsiella pneumoniae Infections, Colistin

Brief summary

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

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

DRUGColistin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Clinical response	—

Secondary

Measure	Time frame
Microbiological response	—

Countries

Thailand

Contacts

Primary ContactVisanu Thamlikitkul, MD

sivth@mahidol.ac.th662 419 7000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026