Addition of Tobramycin Inhalation in the Treatment of Ventilator Associated Pneumonia

NCT02440828 | Completed Phase 4 DMC

• 2 other identifiers: VAP-20142014-001406-17
• Study Type: interventional
• Target: 80
• Locations: 2 countries
• Sites: 2

Brief Summary

This study evaluates the addition of tobramycin inhalation treatment to standard intravenous therapy in the treatment of ventilator associated pneumonia.

Conditions

Ventilator Associated Pneumonia (VAP)

Outcome Measures

Primary Outcomes (1)

• response after 72 h of treatment

  non response is considered when at least one of the following is present 1. No improvement of the arterial O2 tension to inspired O2 fraction ratio 2. Persistence of fever (≥38°C) or hypothermia (\<35.5°C) together with purulent respiratory secretions 3. increase in the pulmonary infiltrates on chest radiograph of greater than or equal to 50% 4. occurrence of septic shock or multiple organ dysfunction syndrome, defined as three or more organ system failures not present on Day 1

  72 hours

Secondary Outcomes (60)

• Mortality rate

  day 30

• Mortality rate

  day 90

• ICU survival

  day 90

• Absence of hospital admittance at day 60

  day 60

• Discharge from the ICU

  up to 60 days

Study Arms (2)

tobramycin inhalation

EXPERIMENTAL

twice daily tobramycin inhalation (Bramitob) 300 mg and standard intravenous antibiotics treatment

Drug: tobramycin inhalation

Placebo

PLACEBO COMPARATOR

twice daily placebo inhalation and standard intravenous antibiotics treatment

Drug: placebo

Interventions

tobramycin inhalation DRUG

tobramycin inhalation 300 mg twice daily

Also known as: Bramitob

tobramycin inhalation

placebo DRUG

NaCl 0.9% inhalation 4 ml twice daily

Also known as: NaCl 0.9% inhalation 4 ml

Placebo

Eligibility Criteria

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

You may qualify if:

• Mechanical ventilation 48 hours or more
• New or progressive radiologic pulmonary infiltrate
• Together with at least two of the following three criteria (\< 24 h):
• temperature \>38°C
• leukocytosis \>12,000/mm3 or leucopenia \<4,000/mm3
• purulent respiratory secretions

You may not qualify if:

• patients with allergy to tobramycin
• pregnancy
• expected to die within 72 hours after enrollment

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Chiesi Farmaceutici S.p.A.: collaborator

Study Sites (2)

Erasmus MC

Rotterdam, 3000CA, Netherlands

Location

Hospital Clinic

Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Interventions

Inhalation

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)

Respiratory Mechanics; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Menno Van der Eerden, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 13, 2015
• First Posted: May 12, 2015
• Study Start: March 1, 2015
• Primary Completion: March 1, 2020
• Study Completion: July 1, 2020
• Last Updated: August 18, 2021

Record last verified: 2021-08

Locations

NL (1); ES (1)