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Completed

NCT Number: NCT03622450

The Effect of Colistin Inhalation on Ventilator Associated Pneumonia

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

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Key information

Conditions

Ventilator Associated Pneumonia Cross Infection Disease Attributes Healthcare-Associated Pneumonia Iatrogenic Disease Infections Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Ventilator-Associated Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Colistin

Drug

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

Other names: Colomycin

Carbapenem + Aminoglycoside/ Quinolone

Drug

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

Other names: tienam,meropenem,levofloxacin,ciprofloxacin,amikacin,gentamicin

Primary outcomes

  1. Assessment of Ventilatory status

    Time frame: 7 to 10 days

    Pf ratio measurement

Secondary outcomes

  1. Days of mechanical ventilation

    Time frame: 35 Days

    Deescalation in the ventilation mode and trials until successful weaning.

  2. Time till the occurence of sepsis

    Time frame: 35 Days

    long standing ventilator associated pneumonia with failure of treatment can lead to sepsis

  3. Mortality as an outcome of long stand untreatable ventilator associated pneumonia

    Time frame: 35 days

    is the mortality due to sepsis of other causes

  4. Length of stay in the icu

    Time frame: 35 days

    How long will the patient stay in the ICU according to failure of weaning and progression of the disease.

Sponsors and collaborators

Lead sponsor

Nourhan Hassan Osama Thuraya Mohamed

Other

Collaborators

  • Ain Shams University

Registry information

Official study title

The Effect of Colistin Inhalation on the Clinical Outcome of Patients With Ventilator Associated Pneumonia

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 9, 2018
Registry last updated
Aug 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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