The Effect of Colistin Inhalation on Ventilator Associated Pneumonia

Nourhan Hassan Osama Thuraya Mohamed

Status and phase: Completed; Phase 3; Phase 2

Conditions: Ventilator Associated Pneumonia

Treatments: Drug: Colistin; Drug: Carbapenem + Aminoglycoside/ Quinolone

Study type: Interventional

Funder types: Other

Identifiers

NCT03622450

Colistin inhalation form

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Medication arm

Experimental group

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

Treatment:

Drug: Colistin

Control arm

Active Comparator group

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

Treatment:

Drug: Carbapenem + Aminoglycoside/ Quinolone