Addition of Tobramycin Inhalation in the Treatment of Ventilator Associated Pneumonia

NCT ID: NCT02440828

Last Updated: 2021-08-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2020-07-01

Brief Summary

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

Detailed Description

Rationale: Approximately 9-27% of mechanically ventilated patients in the intensive care unit (ICU) develop ventilator-associated pneumonia (VAP). Patients in whom VAP develops have a higher mortality rate up to 50%, stay longer in the intensive care unit (ICU), and require more resources than those without the disease. Despite the availability of modern ICU care and modern antibiotics, the overall clinical cure rate after 72 hours of antibiotic treatment for VAP is only 40%. The cure rate for Pseudomonas aeruginosa is even lower. It is unclear why VAP cure rates are so low. The ATS guidelines recommend IV antibiotic treatment (IV AB), especially directed against gram-negative microorganisms. However, the relatively poor response rates seen with intravenous therapy of VAP and the emergence of MDR organisms makes new treatment options desirable. The ATS/IDSA VAP guidelines recommend that "adjunctive therapy with an inhaled aminoglycoside or polymyxin (colistin) for MDR Gram-negative pneumonia should be considered, especially in patients who are not improving". It is therefore necessary to investigate whether adjunctive therapy with inhalation Tobramycin could ameliorate prognosis. The recommendations by the Society of Infectious Diseases Pharmacists are similar.

Conditions

Ventilator Associated Pneumonia (VAP)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

tobramycin inhalation

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

Group Type: EXPERIMENTAL

tobramycin inhalation

Intervention Type: DRUG

tobramycin inhalation 300 mg twice daily

Placebo

twice daily placebo inhalation and standard intravenous antibiotics treatment

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

NaCl 0.9% inhalation 4 ml twice daily

Interventions

tobramycin inhalation

tobramycin inhalation 300 mg twice daily

Intervention Type: DRUG

placebo

NaCl 0.9% inhalation 4 ml twice daily

Intervention Type: DRUG

Other Intervention Names

Bramitob; NaCl 0.9% inhalation 4 ml

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chiesi Farmaceutici S.p.A.

INDUSTRY

Sponsor Role: collaborator

Erasmus Medical Center

OTHER

Sponsor Role: lead

Responsible Party

R.A.S. Hoek, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Menno Van der Eerden, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Locations

Erasmus MC

Rotterdam, , Netherlands

Hospital Clinic

Barcelona, , Spain

Countries

Netherlands; Spain

Other Identifiers

2014-001406-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

VAP-2014

Identifier Type: -

Identifier Source: org_study_id