Nebulized Colistin for Hospital-Acquired Pneumonia

NCT ID: NCT00920270

Last Updated: 2009-06-15

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

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Brief Summary

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Nebulized Colistin for Adjunctive Therapy of Hospital-Acquired Pneumonia caused by Gram Negative Bacteria should be more effective than conventional therapy

Detailed Description

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Randomized Controlled Clinical Trial in hospitalized adult patients with hospital-acquired pneumonia. The patients are allocated to conventional group or nebulized colistin group. The conventional group receives conventional antibiotics whereas the nebulized colistin group receives nebulized colistin in addition to conventional antibiotics. The outcomes are clinical response and microbiological responses.

Conditions

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Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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antibiotic

conventional antibiotics

Group Type ACTIVE_COMPARATOR

antibiotics

Intervention Type DRUG

conventional parenteral antibiotics

colistin group

nebulized colistin

Group Type EXPERIMENTAL

nebulized colistin

Intervention Type DRUG

nebulized colistin 75 mg every 12 hours

Interventions

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nebulized colistin

nebulized colistin 75 mg every 12 hours

Intervention Type DRUG

antibiotics

conventional parenteral antibiotics

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult (age\>18 years) hospitalized patient with hospital-acquired pneumonia due to Gram negative bacteria

Exclusion Criteria

* pregnancy
* lactating woman
* colistin allergy
* severe renal impairment
* epilepsy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Siriraj Hospital

Principal Investigators

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Visanu Thamlikitkul, MD

Role: PRINCIPAL_INVESTIGATOR

Siriraj Hospital

Locations

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Siriraj Hospital

Bangkok, Bangkok, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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Siriraj CEU 50-002

Identifier Type: -

Identifier Source: org_study_id

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