A Phase 4 interventional study of tobramycin inhalation and placebo in Ventilator Associated Pneumonia (VAP), sponsored by Erasmus Medical Center. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-18.
Sponsored by Erasmus Medical Center · Phase 4, Interventional, and Treatment
This study evaluates the addition of tobramycin inhalation treatment to standard intravenous therapy in the treatment of ventilator associated pneumonia.
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.
2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.
This study's planned enrollment of 80 is below the median of 106 across 1,247 interventional studies indexed under Pneumonia.
Browse Pneumonia studies →Erasmus Medical Center is the lead sponsor of 466 studies on the registry; 179 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Together with at least two of the following three criteria (\< 24 h):
Exclusion Criteria:
twice daily tobramycin inhalation (Bramitob) 300 mg and standard intravenous antibiotics treatment
Drug: tobramycin inhalation
twice daily placebo inhalation and standard intravenous antibiotics treatment
Drug: placebo
tobramycin inhalation 300 mg twice daily
Also known as: Bramitob
NaCl 0.9% inhalation 4 ml twice daily
Also known as: NaCl 0.9% inhalation 4 ml
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
Time frame: 72 hours
Mortality rate
30-day and 90- day mortality rate
Time frame: day 30
Mortality rate
30-day and 90- day mortality rate
Time frame: day 90
ICU survival
Time frame: day 90
Absence of hospital admittance at day 60
Time frame: day 60
Discharge from the ICU
Patients will be followed during ICU stay and evaluated at discharge from ICU, expected average time of discharge is 10 days
Time frame: up to 60 days
Ventilator free days at day 28
Time frame: up to 28 days
Adverse events
Time frame: day 1
Adverse events
Time frame: day 4
Adverse events
Time frame: day 8
Adverse events
Time frame: day 14
Adverse events
Time frame: day 30
Adverse events
Time frame: day 90
Day of normalisation of CRP
Time frame: day 1
Day of normalisation of CRP
Time frame: day 4
Day of normalisation of CRP
Time frame: day 8
Day of normalisation of CRP
Time frame: day 14
Day of normalisation of CRP
Time frame: day 30
Day of normalisation of CRP
Time frame: day 90
Eradication of pathogens
Time frame: day 4
Eradication of pathogens
Time frame: day 8
Eradication of pathogens
Time frame: day 14
Eradication of pathogens
Time frame: day 30
Eradication of pathogens
Time frame: day 90
Clinical Pulmonary Infectious Score (CPIS)
Time frame: Day 1
Clinical Pulmonary Infectious Score (CPIS)
Time frame: Day 4
Clinical Pulmonary Infectious Score (CPIS)
Time frame: Day 8
Clinical Pulmonary Infectious Score (CPIS)
Time frame: Day 14
Clinical Pulmonary Infectious Score (CPIS)
Time frame: discharge ICU, expected average time of discharge is 10 days
APACHE II score
Time frame: Day 1
APACHE II score
Time frame: Day 4
APACHE II score
Time frame: Day 8
APACHE II score
Time frame: Day 14
APACHE II score
Time frame: discharge ICU, expected average time of discharge is 10 days
Multiple Organ Dysfunction score (MODS)
Time frame: Day 1
Multiple Organ Dysfunction score (MODS)
Time frame: Day 4
Multiple Organ Dysfunction score (MODS)
Time frame: Day 8
Multiple Organ Dysfunction score (MODS)
Time frame: Day 14
Multiple Organ Dysfunction score (MODS)
Time frame: discharge ICU, expected average time of discharge is 10 days
Sequential Organ Failure Assessment score (SOFA)
Time frame: Day 1
Sequential Organ Failure Assessment score (SOFA)
Time frame: Day 4
Sequential Organ Failure Assessment score (SOFA)
Time frame: Day 8
Sequential Organ Failure Assessment score (SOFA)
Time frame: Day 14
Sequential Organ Failure Assessment score (SOFA)
Time frame: discharge ICU, expected average time of discharge is 10 days
Lung Injury Score (LIS)
Time frame: Day 1
Lung Injury Score (LIS)
Time frame: Day 4
Lung Injury Score (LIS)
Time frame: Day 8
Lung Injury Score (LIS)
Time frame: Day 14
Lung Injury Score (LIS)
Time frame: discharge ICU, expected average time of discharge is 10 days
Day of normalisation of procalcitonin (PCT)
Time frame: day 1
Day of normalisation of procalcitonin (PCT)
Time frame: day 4
Day of normalisation of procalcitonin (PCT)
Time frame: day 8
Day of normalisation of procalcitonin (PCT)
Time frame: day 14
Day of normalisation of procalcitonin (PCT)
Time frame: day 30
Day of normalisation of procalcitonin (PCT)
Time frame: day 90
Day of normalisation of chest X-ray
Time frame: day 1
Day of normalisation of chest X-ray
Time frame: day 4
Day of normalisation of chest X-ray
Time frame: day 8
Day of normalisation of chest X-ray
Time frame: day 14
Day of normalisation of chest X-ray
Time frame: day 30
Day of normalisation of chest X-ray
Time frame: day 90
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Erasmus Medical Center