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The Effect of Colistin Inhalation on Ventilator Associated Pneumonia

Primary Purpose

Ventilator Associated Pneumonia

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Colistin
Carbapenem + Aminoglycoside/ Quinolone
Sponsored by
Nourhan Hassan Osama Thuraya Mohamed
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventilator Associated Pneumonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Medication arm

    Control arm

    Arm Description

    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

    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

    Outcomes

    Primary Outcome Measures

    Assessment of Ventilatory status
    Pf ratio measurement

    Secondary Outcome Measures

    Days of mechanical ventilation
    Deescalation in the ventilation mode and trials until successful weaning.
    Time till the occurence of sepsis
    long standing ventilator associated pneumonia with failure of treatment can lead to sepsis
    Mortality as an outcome of long stand untreatable ventilator associated pneumonia
    is the mortality due to sepsis of other causes
    Length of stay in the icu
    How long will the patient stay in the ICU according to failure of weaning and progression of the disease.

    Full Information

    First Posted
    June 18, 2018
    Last Updated
    August 8, 2018
    Sponsor
    Nourhan Hassan Osama Thuraya Mohamed
    Collaborators
    Ain Shams University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03622450
    Brief Title
    The Effect of Colistin Inhalation on Ventilator Associated Pneumonia
    Official Title
    The Effect of Colistin Inhalation on the Clinical Outcome of Patients With Ventilator Associated Pneumonia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2, 2016 (Actual)
    Primary Completion Date
    January 6, 2018 (Actual)
    Study Completion Date
    January 10, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Nourhan Hassan Osama Thuraya Mohamed
    Collaborators
    Ain Shams University

    4. Oversight

    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
    Data Monitoring Committee
    Yes

    5. 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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ventilator Associated Pneumonia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Medication arm
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Control arm
    Arm Type
    Active Comparator
    Arm Description
    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
    Intervention Type
    Drug
    Intervention Name(s)
    Colistin
    Other Intervention Name(s)
    Colomycin
    Intervention Description
    Polymyxins are bactericidal drugs that bind to lipopolysaccharides (LPS) and phospholipids in the outer cell membrane of gram-negative bacteria.
    Intervention Type
    Drug
    Intervention Name(s)
    Carbapenem + Aminoglycoside/ Quinolone
    Other Intervention Name(s)
    tienam,meropenem,levofloxacin,ciprofloxacin,amikacin,gentamicin
    Intervention Description
    Dual antipseudomonal given as IV for ventilator associated pneumonia for patients with Multi-drug resistant bacteria risk factors
    Primary Outcome Measure Information:
    Title
    Assessment of Ventilatory status
    Description
    Pf ratio measurement
    Time Frame
    7 to 10 days
    Secondary Outcome Measure Information:
    Title
    Days of mechanical ventilation
    Description
    Deescalation in the ventilation mode and trials until successful weaning.
    Time Frame
    35 Days
    Title
    Time till the occurence of sepsis
    Description
    long standing ventilator associated pneumonia with failure of treatment can lead to sepsis
    Time Frame
    35 Days
    Title
    Mortality as an outcome of long stand untreatable ventilator associated pneumonia
    Description
    is the mortality due to sepsis of other causes
    Time Frame
    35 days
    Title
    Length of stay in the icu
    Description
    How long will the patient stay in the ICU according to failure of weaning and progression of the disease.
    Time Frame
    35 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Number of patients ,statistical data, method,discussion and outcome will be shared

    Learn more about this trial

    The Effect of Colistin Inhalation on Ventilator Associated Pneumonia

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