The Effect of Colistin Inhalation on Ventilator Associated Pneumonia

NCT03622450 | Completed Phase 2 DMC

• 1 other identifier: Colistin inhalation form
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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

Conditions

Ventilator Associated Pneumonia

Outcome Measures

Primary Outcomes (1)

• Assessment of Ventilatory status

  Pf ratio measurement

  7 to 10 days

Secondary Outcomes (4)

• Days of mechanical ventilation

  35 Days

• Time till the occurence of sepsis

  35 Days

• Mortality as an outcome of long stand untreatable ventilator associated pneumonia

  35 days

• Length of stay in the icu

  35 days

Study Arms (2)

Medication arm

EXPERIMENTAL

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

Control arm

ACTIVE COMPARATOR

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

Interventions

Colistin DRUG

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

Also known as: Colomycin

Medication arm

Carbapenem + Aminoglycoside/ Quinolone DRUG

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

Also known as: tienam,meropenem,levofloxacin,ciprofloxacin,amikacin,gentamicin

Control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years
• Patients presenting with signs of infection 48 hours of intubation

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nourhan Hassan Osama Thuraya Mohamed: lead
• Ain Shams University: collaborator

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Interventions

Colistin; Carbapenems; Aminoglycosides; Quinolones

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Polymyxins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Lipopeptides; Lipids; Antimicrobial Cationic Peptides; Peptides; Amino Acids, Peptides, and Proteins; Antimicrobial Peptides; Pore Forming Cytotoxic Proteins; Membrane Proteins; Proteins; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glycosides; Carbohydrates; Quinolines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical pharmacist

Study Record Dates

• First Submitted: June 18, 2018
• First Posted: August 9, 2018
• Study Start: January 2, 2016
• Primary Completion: January 6, 2018
• Study Completion: January 10, 2018
• Last Updated: August 9, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share