tobramycin inhalation
Drugtobramycin inhalation 300 mg twice daily
Other names: Bramitob
NCT Number: NCT02440828
This study evaluates the addition of tobramycin inhalation treatment to standard intravenous therapy in the treatment of ventilator associated pneumonia.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Erasmus MC, Rotterdam, Netherlands
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Together with at least two of the following three criteria (< 24 h):
Exclusion criteria
tobramycin inhalation 300 mg twice daily
Other names: Bramitob
NaCl 0.9% inhalation 4 ml twice daily
Other names: NaCl 0.9% inhalation 4 ml
Time frame: 72 hours
non response is considered when at least one of the following is present
Time frame: day 30
30-day and 90- day mortality rate
Time frame: day 90
30-day and 90- day mortality rate
Time frame: day 90
Time frame: day 60
Time frame: up to 60 days
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 28 days
Time frame: day 1
Time frame: day 4
Time frame: day 8
Time frame: day 14
Time frame: day 30
Time frame: day 90
Time frame: day 1
Time frame: day 4
Time frame: day 8
Time frame: day 14
Time frame: day 30
Time frame: day 90
Time frame: day 4
Time frame: day 8
Time frame: day 14
Time frame: day 30
Time frame: day 90
Time frame: Day 1
Time frame: Day 4
Time frame: Day 8
Time frame: Day 14
Time frame: discharge ICU, expected average time of discharge is 10 days
Time frame: Day 1
Time frame: Day 4
Time frame: Day 8
Time frame: Day 14
Time frame: discharge ICU, expected average time of discharge is 10 days
Time frame: Day 1
Time frame: Day 4
Time frame: Day 8
Time frame: Day 14
Time frame: discharge ICU, expected average time of discharge is 10 days
Time frame: Day 1
Time frame: Day 4
Time frame: Day 8
Time frame: Day 14
Time frame: discharge ICU, expected average time of discharge is 10 days
Time frame: Day 1
Time frame: Day 4
Time frame: Day 8
Time frame: Day 14
Time frame: discharge ICU, expected average time of discharge is 10 days
Time frame: day 1
Time frame: day 4
Time frame: day 8
Time frame: day 14
Time frame: day 30
Time frame: day 90
Time frame: day 1
Time frame: day 4
Time frame: day 8
Time frame: day 14
Time frame: day 30
Time frame: day 90
Erasmus Medical Center
Other
Ventilator Associated Pneumonia: Addition of Tobramycin Inhalation Antibiotic Treatment to Standard IV Antibiotic Treatment
Acronym: VAPORISE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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