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The Effect of Colistin Inhalation on Ventilator Associated Pneumonia

Sponsor
Nourhan Hassan Osama Thuraya Mohamed (Other)
Overall Status
Completed
CT.gov ID
NCT03622450
Collaborator
Ain Shams University (Other)
40
Enrollment
2
Arms
24.3
Actual Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Effect of Colistin Inhalation on the Clinical Outcome of Patients With Ventilator Associated Pneumonia
Actual Study Start Date :
Jan 2, 2016
Actual Primary Completion Date :
Jan 6, 2018
Actual Study Completion Date :
Jan 10, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

Drug: Colistin
Polymyxins are bactericidal drugs that bind to lipopolysaccharides (LPS) and phospholipids in the outer cell membrane of gram-negative bacteria.
Other Names:
  • Colomycin

    		•
    Active Comparator: 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

    Drug: Carbapenem + Aminoglycoside/ Quinolone
    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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Assessment of Ventilatory status [7 to 10 days]

      Pf ratio measurement

    Secondary Outcome Measures

    1. Days of mechanical ventilation [35 Days]

      Deescalation in the ventilation mode and trials until successful weaning.

    2. Time till the occurence of sepsis [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 [35 days]

      is the mortality due to sepsis of other causes

    4. Length of stay in the icu [35 days]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Nourhan Hassan Osama Thuraya Mohamed
    • Ain Shams University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nourhan Hassan Osama Thuraya Mohamed, Clinical pharmacist, Ain Shams University
    ClinicalTrials.gov Identifier:
    NCT03622450
    Other Study ID Numbers:
    • Colistin inhalation form
    First Posted:
    Aug 9, 2018
    Last Update Posted:
    Aug 9, 2018
    Last Verified:
    Aug 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Pneumonia
    Pneumonia, Ventilator-Associated
    Ciprofloxacin
    Levofloxacin
    Gentamicins
    Meropenem
    Amikacin
    Colistin

    Study Results

    No Results Posted as of Aug 9, 2018