Pneumonia obtained by mechanical ventilation: investigation whether adding inhalation antibiotics with tobramycin to standard intravenous antibiotic treatment is better than intravenous antibiotic treatment alone

• Conditions: ICU patients with ventilator-associated pneumonia; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2014-001406-17-NL
• Lead Sponsor: Erasmus MC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08-05
• Last Update Posted: 16 February 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

The clinical suspicion of pneumonia is based on the ATS criteria:
-new or progressive radiologic pulmonary infiltrate
Together with at least two of the following three criteria:
-temperature >38°C
-leukocytosis >12,000/mm3 or leucopenia <4,000/mm3
-purulent respiratory secretions

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 54

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified