The Effect of Colistin Inhalation on Ventilator Associated Pneumonia

NCT ID: NCT03622450

Last Updated: 2018-08-09

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

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-02

Study Completion Date

2018-01-10

Brief Summary

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The study has been conducted to measure the clinical outcome of early intervention with colistin inhalation in patients with ventilator associated pneumonia suspected to have multidrug resistant gram -ve bacteria

Detailed Description

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Conditions

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Ventilator Associated Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Medication arm

Colistin to be given as 2 millions three times daily in the inhalation form from 5 to 7 days in addition to another antipseudomonal antibiotic according to infectious disease society of antimicrobials (IDSA) guidelines from day 1 of incidence of ventilator associated pneumonia

Group Type EXPERIMENTAL

Colistin

Intervention Type DRUG

Polymyxins are bactericidal drugs that bind to lipopolysaccharides (LPS) and phospholipids in the outer cell membrane of gram-negative bacteria.

Control arm

Patients receive antipseudomonal antibiotics IV as carbapenem and quinolone or aminoglycoside according to IDSA guidelines from day 1 of incidence of Ventilator associated pneumonia carbapenem as 1g three times daily + tavanic 750mg once daily or ciprofloxacin 500mg twice daily or aminoglycoside according to renal function

Group Type ACTIVE_COMPARATOR

Carbapenem + Aminoglycoside/ Quinolone

Intervention Type DRUG

Dual antipseudomonal given as IV for ventilator associated pneumonia for patients with Multi-drug resistant bacteria risk factors

Interventions

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Colistin

Polymyxins are bactericidal drugs that bind to lipopolysaccharides (LPS) and phospholipids in the outer cell membrane of gram-negative bacteria.

Intervention Type DRUG

Carbapenem + Aminoglycoside/ Quinolone

Dual antipseudomonal given as IV for ventilator associated pneumonia for patients with Multi-drug resistant bacteria risk factors

Intervention Type DRUG

Other Intervention Names

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Colomycin tienam,meropenem,levofloxacin,ciprofloxacin,amikacin,gentamicin

Eligibility Criteria

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Inclusion Criteria

* Age 18 years

Patients presenting with signs of infection 48 hours of intubation

Exclusion Criteria

* Patients with documented bronchiectasis

Cystic fibrosis Known allergy to polymyxin. Patients presenting with chest infection or signs of infection before intubation.

Patients with creatinine clearance less than 30ml/min.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role collaborator

Nourhan Hassan Osama Thuraya Mohamed

OTHER

Sponsor Role lead

Responsible Party

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Nourhan Hassan Osama Thuraya Mohamed

Clinical pharmacist

Responsibility Role SPONSOR_INVESTIGATOR

Other Identifiers

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Colistin inhalation form

Identifier Type: -

Identifier Source: org_study_id

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