The Effect of Colistin Inhalation on Ventilator Associated Pneumonia

The Effect of Colistin Inhalation on the Clinical Outcome of Patients With 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

Study Overview

• Status: Completed
• Conditions: Ventilator Associated Pneumonia
• Intervention / Treatment: Drug: Colistin; Drug: Carbapenem + Aminoglycoside/ Quinolone

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Ventilatory status	Pf ratio measurement	7 to 10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Days of mechanical ventilation	Deescalation in the ventilation mode and trials until successful weaning.	35 Days
Time till the occurence of sepsis	long standing ventilator associated pneumonia with failure of treatment can lead to sepsis	35 Days
Mortality as an outcome of long stand untreatable ventilator associated pneumonia	is the mortality due to sepsis of other causes	35 days
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.	35 days

Collaborators and Investigators

• Sponsor: Nourhan Hassan Osama Thuraya Mohamed
• Collaborators: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2016
• Primary Completion (Actual): January 6, 2018
• Study Completion (Actual): January 10, 2018

Study Registration Dates

• First Submitted: June 18, 2018
• First Submitted That Met QC Criteria: August 8, 2018
• First Posted (Actual): August 9, 2018

Study Record Updates

• Last Update Posted (Actual): August 9, 2018
• Last Update Submitted That Met QC Criteria: August 8, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Pneumonia; Pneumonia, Ventilator-Associated; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Anti-Infective Agents, Urinary; Renal Agents; Gentamicins; Ciprofloxacin; Meropenem; Levofloxacin; Colistin; Amikacin
• Other Study ID Numbers: Colistin inhalation form

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Number of patients ,statistical data, method,discussion and outcome will be shared

Drug and device information, study documents

• 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