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

Ventilator Associated Pneumonia: addition of Tobramycin Inhalation antibiotic treatment to standard IV antibiotic treatment

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-001406-17-NL

Enrollment

Registered

2014-08-05

Start date

2015-01-21

Completion date

Unknown

Last updated

2015-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ICU patients with ventilator-associated pneumonia

Interventions

Trade Name: Bramitob Product Name: Bramitob Product Code: 033841 Pharmaceutical Form: Inhalation vapour, solution Pharmaceutical form of the placebo: Inhalation vapour, solution Route of administratio

Eligibility

Sex/Gender

All

Inclusion criteria

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 =65 years) yes F.1.3.1 Number of subjects for this age range 54

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: Does addition of inhalation tobramycin to standard IV treatment result in a higher clinical cure rate than standard IV antibiotic treatment alone in patients with ventilator-associated pneumonia. The initial response to treatment will be evaluated after 3 days of antimicrobial treatment. ;Secondary Objective: Does addition of inhalation tobramycin to standard IV treatment result in a lower mortality and shorter length of stay than standard IV antibiotic treatment alone in patients with ventilator-associated pneumonia. Does addition of inhalation tobramycin to standard IV treatment result in an improved bacterial eradication rate than standard IV antibiotic treatment alone in patients with ventilator-associated pneumonia. In case of non-response at day 4, what are the causes of non-response? ;Primary end point(s): Nonresponse is considered when at least one of the following criteria 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 ;Timepoint(s) of evaluation of this end point: The initial response to treatment will be evaluated after 3 days of antimicrobial treatment.	—

Measure

Time frame

Main Objective: Does addition of inhalation tobramycin to standard IV treatment result in a higher clinical cure rate than standard IV antibiotic treatment alone in patients with ventilator-associated pneumonia. The initial response to treatment will be evaluated after 3 days of antimicrobial treatment. ;Secondary Objective: Does addition of inhalation tobramycin to standard IV treatment result in a lower mortality and shorter length of stay than standard IV antibiotic treatment alone in patients with ventilator-associated pneumonia. Does addition of inhalation tobramycin to standard IV treatment result in an improved bacterial eradication rate than standard IV antibiotic treatment alone in patients with ventilator-associated pneumonia. In case of non-response at day 4, what are the causes of non-response? ;Primary end point(s): Nonresponse is considered when at least one of the following criteria 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 ;Timepoint(s) of evaluation of this end point: The initial response to treatment will be evaluated after 3 days of antimicrobial treatment.

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Secondary

Measure	Time frame
Secondary end point(s): - 30-day and 90- day mortality rate - ICU survival - Number of days without mechanical ventilation - length of stay - discharge from the ICU - duration of mechanical ventilation - adverse events - day of normalisation of CRP, procalcitonin (PCT) and chest X-ray - eradication of pathogens (especially pseudomonas) - Clinical Pulmonary Infectious Score (31); APACHE II score; multiple organ dysfunction score (MODS) - Cytokine response - Causes of nonresponse. In patients with initial nonresponse to treatment, cultures of respiratory samples and blood will be obtained again, and the empiric antimicrobial treatment will be revised ;Timepoint(s) of evaluation of this end point: The initial response to treatment will be evaluated after 3 days of antimicrobial treatment. and at day 8, 14, discharge ICU, discharge hospital, Day 30, Day 90	—

Measure

Time frame

Secondary end point(s): - 30-day and 90- day mortality rate - ICU survival - Number of days without mechanical ventilation - length of stay - discharge from the ICU - duration of mechanical ventilation - adverse events - day of normalisation of CRP, procalcitonin (PCT) and chest X-ray - eradication of pathogens (especially pseudomonas) - Clinical Pulmonary Infectious Score (31); APACHE II score; multiple organ dysfunction score (MODS) - Cytokine response - Causes of nonresponse. In patients with initial nonresponse to treatment, cultures of respiratory samples and blood will be obtained again, and the empiric antimicrobial treatment will be revised ;Timepoint(s) of evaluation of this end point: The initial response to treatment will be evaluated after 3 days of antimicrobial treatment. and at day 8, 14, discharge ICU, discharge hospital, Day 30, Day 90

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Countries

Netherlands

Contacts

Public Contactresearch longziekten

Erasmus MC

research.longziekten@erasmusmc.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026