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

NCT ID: NCT00300560

Last Updated: 2006-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2006-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Colistin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Principal Investigators

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Visanu Thamlikitkul, MD

Role: PRINCIPAL_INVESTIGATOR

Siriraj Hospital

Locations

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Division of Infectious disease and Tropical Medicine, Department of Medicine, Faculty of Medicine Siriraj Hospital

Bangkoknoi, Bangkok, Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Visanu Thamlikitkul, MD

Role: CONTACT

[email protected]
662 419 7000 ext. 6626

Facility Contacts

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Sunee Thanakhumtorn, RN

Role: primary

[email protected]
662 4197000 ext. 6616

Other Identifiers

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SirirajCEU49-004

Identifier Type: -

Identifier Source: org_study_id