Study the efficacy on the use of inhaled tobramycin in the reduction of the time to mechanical ventilation in patients undergoing mechanical ventilation and colonized by Gram Negative

A Phase III clinical trial randomized and blinded on the use of inhaled tobramycin compared with placebo in patients undergoing mechanical ventilation and colonized by Gram negative bacteria for effectiveness in reducing the time mecánica.mechanical ventilation ventilation in patients Undergoing mechanical ventilation and colonized by Gram Negative

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-001109-15-ES

Enrollment

Registered

2015-11-18

Start date

2015-12-15

Completion date

Unknown

Last updated

2020-07-27

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

Conditions

critically ill patients undergoing mechanical ventilation MedDRA version: 18.1 Level: PT Classification code 10066821 Term: Mechanical ventilation complication System Organ Class: 10022117 - Injury, poisoning and procedural complications

Interventions

Trade Name: Tobramycin Pharmaceutical Form: Inhalation solution INN or Proposed INN: TOBRAMYCIN Other descriptive name: TOBRAMYCIN INHALATE Concentration unit: mg/ml milligram(s)/millilitre Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients older than 18 years, admitted to the ICU, undergoing mechanical ventilation and carriers artificial airway (endotracheal tube or tracheostomy) for at least 7 days and meet the following requirements: a. Persistent colonization of the airway sensitive to tobramycin Gram negative bacteria. Persistent define as the isolation of the same organism in at least two respiratory samples with minimal time separation of 72h. b. Abundant and / or purulent Bronchorrhea that the judgment of the attending physician may interfere with the patient's respiratory process 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 68 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Allergy to aminoglycosides. - Refusal of informed consent. - Renal insufficiency, creatinine clearance <60 ml / min or use of renal replacement - Pregnant or lactating women. - Data suggestive of respiratory infection associated with mechanical ventilation (pneumonia or tracheobronchitis) at the time of inclusion in the study. Respiratory colonization by bacteria resistant to tobramycin. - Limitation of therapeutic effort. - Participation in another clinical trial within the previous 30 days. - Bronchiectasis or cystic fibrosis. - Patients being treated with furosemide, urea or mannitol

Design outcomes

Primary

Measure	Time frame
Secondary Objective: Reduce by 10% the time of artificial airway in patients treated with inhaled tobramycin compared to patients treated with placebo - Evaluate the clinical and microbiological response in patients treated with inhaled tobramycin compared to patients treated with placebo. - Analyze the formation of biofilm and the persistence of viable microorganisms on the surface of the endotracheal tube or tracheostomy tube removed after treatment with inhaled tobramycin vs. placebo. - Analyze the occurrence of respiratory infections until day 28 after the last dose of treatment in patients treated with inhaled tobramycin compared to patients treated with placebo. - Evaluate the emergence of resistance to tobramycin in respiratory samples and microbiological samples from other sources in patients treated with inhaled tobramycin compared to patients treated with placebo. - Analyze the pharmacokinetic behavior of inhaled tobramycin in the study population.;Primary end point(s): Duration of mechanical ventilation;Timepoint(s) of evaluation of this end point: Time measured in hours from the onset of mechanical ventilation to successful cessation of mechanical ventilation.;Main Objective: Reduce by 10% the duration of mechanical ventilation in patients treated with inhaled tobramycin compared to patients treated with placebo.	—

Measure

Time frame

Secondary Objective: Reduce by 10% the time of artificial airway in patients treated with inhaled tobramycin compared to patients treated with placebo - Evaluate the clinical and microbiological response in patients treated with inhaled tobramycin compared to patients treated with placebo. - Analyze the formation of biofilm and the persistence of viable microorganisms on the surface of the endotracheal tube or tracheostomy tube removed after treatment with inhaled tobramycin vs. placebo. - Analyze the occurrence of respiratory infections until day 28 after the last dose of treatment in patients treated with inhaled tobramycin compared to patients treated with placebo. - Evaluate the emergence of resistance to tobramycin in respiratory samples and microbiological samples from other sources in patients treated with inhaled tobramycin compared to patients treated with placebo. - Analyze the pharmacokinetic behavior of inhaled tobramycin in the study population.;Primary end point(s): Duration of mechanical ventilation;Timepoint(s) of evaluation of this end point: Time measured in hours from the onset of mechanical ventilation to successful cessation of mechanical ventilation.;Main Objective: Reduce by 10% the duration of mechanical ventilation in patients treated with inhaled tobramycin compared to patients treated with placebo.

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Secondary

Measure	Time frame
Secondary end point(s): Artificial airway time Clinical response Microbiological response. Microbiological Elimination Respiratory infection associated with mechanical ventilation: The diagnosis of pneumonia associated with mechanical ventilation (VAP) will be in accordance with established criteria. Presence of pulmonary infiltrates or progression of preexisting condensation on chest radiograph plus two of the following three clinical variables: fever> 38 °, leukocytosis (> 12,000 / mm3) or leukopenia (<4,000 / mm3) and purulent respiratory secretions.;Timepoint(s) of evaluation of this end point: Time artificial airway: part time in hours from the insertion of the artificial airway to the successful withdrawal thereof Clinical response: Measured as the improvement of gas exchange and the disappearance of purulent secretions. Microbiological response: Positive if there is a reduction of at least 50% in quantitative microbiological culture of respiratory specimens after initiation of treatment. Microbiological eradication: when the initial bacteria can not isolate the corresponding crops. Respiratory infection associated with mechanical ventilation Diagnostic confirmation will be by quantitative culture of respiratory sample with the cutoff established by the Spanish Society of Infectious Diseases and Clinical Microbiology	—

Measure

Time frame

Secondary end point(s): Artificial airway time Clinical response Microbiological response. Microbiological Elimination Respiratory infection associated with mechanical ventilation: The diagnosis of pneumonia associated with mechanical ventilation (VAP) will be in accordance with established criteria. Presence of pulmonary infiltrates or progression of preexisting condensation on chest radiograph plus two of the following three clinical variables: fever> 38 °, leukocytosis (> 12,000 / mm3) or leukopenia (<4,000 / mm3) and purulent respiratory secretions.;Timepoint(s) of evaluation of this end point: Time artificial airway: part time in hours from the insertion of the artificial airway to the successful withdrawal thereof Clinical response: Measured as the improvement of gas exchange and the disappearance of purulent secretions. Microbiological response: Positive if there is a reduction of at least 50% in quantitative microbiological culture of respiratory specimens after initiation of treatment. Microbiological eradication: when the initial bacteria can not isolate the corresponding crops. Respiratory infection associated with mechanical ventilation Diagnostic confirmation will be by quantitative culture of respiratory sample with the cutoff established by the Spanish Society of Infectious Diseases and Clinical Microbiology

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Countries

Spain

Contacts

Public ContactUREC

INSTITUTO DE INVESTIGACION SANITARIA LA FE

investigacion_clinica@iislafe.es34961246611

Outcome results

None listed

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