Pneumonia, Ventilator-AssociatedPhase 4TOP-MDRVAPNCT07856355
Tobramycin Nebulization to Prevent Multidrug-Resistant Ventilator-Associated Pneumonia
A Phase 4 study testing Tobramycin inhalation solution in people with Pneumonia, Ventilator-Associated, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The TOP-MDRVAP trial will test whether inhaled tobramycin can safely prevent pneumonia caused by multidrug-resistant bacteria in adults who need a breathing machine. Tobramycin is an antibiotic. Multidrug-resistant bacteria are bacteria that resist treatment with several types of antibiotics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Ventilator-Associated
- What is being tested?
- Tobramycin inhalation solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 574 participants
- Where
- 1 siteChina
- Study dates
- 7 Oct 2026to 29 Jan 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years at enrollment.
- Invasive mechanical ventilation through an endotracheal tube for ≥72 hours and ≤96 hours, measured from the time of intubation, with an anticipated requirement for at least another 72 hours of invasive mechanical ventilation, as assessed by the attending physician.
- At least one of the following risk factors for multidrug-resistant (MDR) bacterial infection:
- 3.1 Exposure to systemic antibiotics for ≥24 hours within the 30 days before enrollment.
- 3.2 Current hospitalization for at least 120 hours before randomization. 3.3 Septic shock requiring vasoactive medication to maintain a mean arterial pressure ≥65 mmHg, with a blood lactate level >2 mmol/L.
- 3.4 Moderate-to-severe acute respiratory distress syndrome (ARDS), according to the Berlin definition, with a PaO2/FiO2 ratio ≤200 mmHg and positive end-expiratory pressure (PEEP) ≥5 cm H2O.
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- 3.5 Current renal replacement therapy, including continuous renal replacement therapy or intermittent hemodialysis.
- 3.6 A history of MDR bacterial colonization or infection within the previous 12 months, documented by clinical culture.
- Written informed consent obtained from the patient or the patient's legally authorized representative.
Who cannot join
- Suspected or confirmed ventilator-associated pneumonia (VAP) on the day of enrollment, based on the attending physician's clinical judgment.
- Continuous invasive mechanical ventilation for more than 96 hours before enrollment.
- Planned extubation within the next 24 hours.
- Previous tracheostomy.
- A history of allergy to tobramycin or any other aminoglycoside antibiotic.
- Use of tobramycin within the 7 days before enrollment; ongoing treatment with any aminoglycoside antibiotic at enrollment; or a clinical indication for intravenous treatment with any aminoglycoside antibiotic at enrollment.
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- Chronic kidney disease (stages 4-5) with a baseline estimated glomerular filtration rate (eGFR) ≤30 mL/min/1.73 m², or acute kidney injury meeting the protocol-specified Kidney Disease: Improving Global Outcomes (KDIGO) stage 3 criteria: serum creatinine increased to three times baseline, serum creatinine >353.6 μmol/L, urine output <0.3 mL/kg/hour for more than 24 hours, or anuria for more than 12 hours. Patients currently receiving renal replacement therapy are exempt from this renal exclusion criterion.
- Expected survival of no more than 48 hours, as assessed by the attending physician.
- Pregnancy, indicated by a positive serum or urine human chorionic gonadotropin (hCG) test, or breastfeeding.
- Concurrent participation in another interventional clinical study involving nebulized antibiotics or other ventilator-associated pneumonia prevention interventions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Gensheng Zhang, +86 18806812331, genshengzhang@zju.edu.cn
About this study
Official title: Tobramycin Nebulization to Prevent Multidrug-Resistant Ventilator-Associated Pneumonia: A Prospective, Multicenter, Double-Blind, Randomized Controlled Trial
The TOP-MDRVAP trial will test whether inhaled tobramycin can safely prevent pneumonia caused by multidrug-resistant bacteria in adults who need a breathing machine. Tobramycin is an antibiotic. Multidrug-resistant bacteria are bacteria that resist treatment with several types of antibiotics. Pneumonia that develops in patients receiving breathing support through a breathing tube is called ventilator-associated pneumonia (VAP). This study will evaluate tobramycin as a preventive treatment, rather than as treatment for existing VAP.
The study plans to enroll 574 adults aged 18 years or older in intensive care units (ICUs) at several hospitals. Participants must have received breathing support through a tube for 72 to 96 hours and be expected to need this support for at least another 72 hours. They must have at least one risk factor for infection with multidrug-resistant bacteria and must not have suspected or confirmed VAP when entering the study.
Read more
Participants will be assigned by chance to one of two groups, with an equal chance of entering either group. One group will receive tobramycin inhalation solution, 300 mg in 5 mL, twice daily for 3 consecutive days. The other group will receive 5 mL of 0.9% saline, a saltwater solution containing no antibiotic, on the same schedule. A nebulizer will turn the solution into a fine mist delivered through the breathing tube.
Both groups will receive standard measures to prevent VAP. Participants, their representatives, the healthcare professionals providing their direct care, and the researchers assessing outcomes will not know which study treatment each participant receives.
The main question is whether fewer participants develop VAP caused by multidrug-resistant bacteria within 28 days after assignment to a study group. Researchers will also compare the occurrence of VAP from any cause, antibiotic use, time receiving breathing support, time spent in the ICU and hospital, and deaths within 28 and 90 days.
Participants will be monitored for possible side effects, including kidney problems, narrowing of the airways, and complications involving the breathing tube or equipment. Samples will be tested for bacteria and antibiotic resistance. Follow-up will continue for up to 90 days after assignment, using hospital records or telephone contact to assess survival and recovery milestones, including discharge and the end of breathing support.
- Conditions
- Pneumonia, Ventilator-Associated
- Being tested
- Tobramycin inhalation solution, 0.9% Sodium Chloride Placebo
- Keywords
- Tobramycin, Inhaled Antibiotics, Antibiotic Prophylaxis, Ventilator-Associated Pneumonia, Multidrug-Resistant Bacteria, Invasive Mechanical Ventilation, Critically Ill Patients, Intensive Care Unit
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tobramycin inhalation solutionDrug
Tobramycin inhalation solution (300 mg/5 mL) is administered at a dose of 300 mg (5 mL) twice daily for 3 consecutive days, for a total of 6 planned doses. The ready-to-use solution is administered without additional dilution through the endotracheal tube using a vibrating mesh nebulizer connected to the ventilator circuit. Each nebulization continues until the nebulizer reservoir is empty. The intervention is administered to prevent multidrug-resistant ventilator-associated pneumonia (MDR-VAP), in addition to standard VAP prevention measures.
0.9% Sodium Chloride PlaceboDrug
A 5 mL dose of 0.9% sodium chloride solution (normal saline) is administered as a placebo twice daily for 3 consecutive days, for a total of 6 planned doses. The solution is delivered through the endotracheal tube using the same type of vibrating mesh nebulizer, administration schedule, and nebulization procedure as the tobramycin intervention. Each nebulization continues until the nebulizer reservoir is empty. Participants also receive standard VAP prevention measures.
| Study group | Role | What they receive |
|---|---|---|
| Nebulized Tobramycin | Experimental | Participants receive tobramycin inhalation solution, 300 mg in 5 mL per dose, administered through the endotracheal tube using a vibrating mesh nebulizer twice daily for 3 consecutive days (6 planned doses). The intervention is administered to prevent multidrug-resistant ventilator-associated pneumonia (MDR-VAP). Participants also receive standard ventilator-associated pneumonia (VAP) prevention measures. Receives: Drug: Tobramycin inhalation solution |
| Nebulized 0.9% Sodium Chloride Placebo | Placebo comparator | Participants receive 5 mL of 0.9% sodium chloride solution (normal saline) as a placebo, administered through the endotracheal tube using a vibrating mesh nebulizer twice daily for 3 consecutive days (6 planned doses). Participants also receive standard ventilator-associated pneumonia (VAP) prevention measures. Receives: Drug: 0.9% Sodium Chloride Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-Day Cumulative Incidence of Multidrug-Resistant Ventilator-Associated Pneumonia
Percentage of randomized participants with a first episode of multidrug-resistant ventilator-associated pneumonia (MDR-VAP), adjudicated by an independent blinded endpoint adjudication committee. VAP develops after 48 hours of mechanical ventilation, including within 48 hours after weaning or extubation. Diagnosis requires new or progressive infiltrates, consolidation, or ground-glass opacities on chest X-ray or CT plus at least two of: temperature >38°C, purulent airway secretions, and white blood cell count >10 x 10^9/L or <4 x 10^9/L. MDR-VAP additionally requires a positive quantitative lower respiratory tract culture (tracheal aspirate ≥10^5 CFU/mL; bronchoalveolar lavage ≥10^4 CFU/mL; protected specimen brush ≥10^3 CFU/mL) with a causative bacterium resistant to at least three antimicrobial classes.
Measured: From randomization through Day 28.
Secondary outcomes (16)
Incidence Density of Multidrug-Resistant Ventilator-Associated Pneumonia
Number of first episodes of multidrug-resistant ventilator-associated pneumonia per 1,000 invasive mechanical ventilation days accumulated during the assessment period.
Measured: From randomization through Day 28.
28-Day Incidence of Ventilator-Associated Pneumonia From Any Cause
28-Day Incidence of Ventilator-Associated Pneumonia From Any Cause
Measured: From randomization through Day 28.
Systemic Antibiotic Use Expressed as Antibiotic-Days
Cumulative systemic antibiotic use during the assessment period, expressed as antibiotic-days.
Measured: From randomization through Day 28.
Days of Exposure to Systemic Antibiotics
Number of days on which a participant receives at least one systemic antibiotic during the assessment period. Each day with systemic antibiotic exposure is counted once, regardless of the number of antibiotics administered.
Measured: From randomization through Day 28.
Duration of Mechanical Ventilation
Total duration of invasive and noninvasive mechanical ventilation, measured in days, during the assessment period.
Measured: From randomization through Day 28.
Intensive Care Unit Length of Stay
Duration of intensive care unit stay, measured in days from randomization to ICU discharge, with follow-up through Day 90.
Measured: From randomization to ICU discharge, assessed up to Day 90.
Hospital Length of Stay
Duration of hospital stay, measured in days from randomization to hospital discharge, with follow-up through Day 90.
Measured: From randomization to hospital discharge, assessed up to Day 90.
28-Day All-Cause Mortality
Percentage of participants who die from any cause within 28 days after randomization.
Measured: From randomization through Day 28.
90-Day All-Cause Mortality
Percentage of participants who die from any cause within 90 days after randomization. Survival status is obtained from hospital records or telephone follow-up.
Measured: From randomization through Day 90.
Incidence of Ventilator-Associated Pneumonia Caused by Tobramycin-Susceptible Gram-Negative Bacteria
Percentage of participants who develop ventilator-associated pneumonia caused by gram-negative bacteria that are susceptible to tobramycin on in vitro antimicrobial susceptibility testing.
Measured: From randomization through Day 28.
Incidence of Ventilator-Associated Events
Percentage of participants who develop a ventilator-associated event, assessed using the protocol-specified 2023 Centers for Disease Control and Prevention/National Healthcare Safety Network definitions. Assessments include ventilator-associated conditions, infection-related ventilator-associated complications, and possible ventilator-associated pneumonia.
Measured: From randomization through Day 28.
Incidence of New-Onset Acute Kidney Injury
Percentage of participants without acute kidney injury at baseline who develop Kidney Disease: Improving Global Outcomes (KDIGO) stage 1 or higher acute kidney injury during the assessment period.
Measured: From randomization through Day 28.
Daily Trajectory of the Clinical Pulmonary Infection Score
Daily Clinical Pulmonary Infection Score (CPIS) values and their longitudinal changes during the assessment period, calculated using available clinical data.
Measured: Assessed daily from randomization until extubation or Day 28, whichever occurs first.
Time to First Successful Spontaneous Breathing Trial
Time, measured in days, from randomization to the first successful spontaneous breathing trial (SBT) during the assessment period.
Measured: From randomization through Day 28.
Detection Rate of Tobramycin-Resistant Bacteria
Rate of isolation of tobramycin-resistant bacteria from respiratory specimens or blood cultures during the assessment period.
Measured: From randomization through Day 28.
Composite Incidence of Serious Nebulization-Related Adverse Effects
Percentage of participants experiencing at least one serious adverse effect related to nebulization, including increased expiratory filter resistance, bronchospasm, or endotracheal tube obstruction.
Measured: From randomization through Day 28.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start7 Oct 2026 (estimated)
- Primary completion31 Oct 2028 (estimated)
- Study completion29 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonia, Ventilator-AssociatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized in a 1:1 ratio to one of two parallel groups: nebulized tobramycin or nebulized 0.9% saline placebo. Both study interventions are administered twice daily for 3 consecutive days.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 574 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Zhejiang University, Sir Run Run Shaw Hospital, The Fourth Affiliated Hospital of Zhejiang University School of Medicine, Zhejiang Hospital, Zhejiang Provincial People's Hospital, Lishui Country People's Hospital, Jinhua People's Hospital, The First People's Hospital of Huzhou, Second Affiliated Hospital of Wenzhou Medical University, Ningbo Medical Center Lihuili Hospital, Qilu Hospital of Shandong University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Zhengzhou Central Hospital, Second Affiliated Hospital of Nanchang University, West China Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine, Weifang People's Hospital, Huang Shan People's Hospital, Jinhua Central Hospital, RenJi Hospital, People's Hospital of Quzhou, Taizhou Hospital, the second people's of kaifeng
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07856355
- Sponsor's protocol ID
- 2026-0634
- Acronym
- TOP-MDRVAP
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in the primary publication of the TOP-MDRVAP trial will be shared, together with a data dictionary. The dataset will include baseline characteristics, treatment allocation, and data supporting the reported efficacy and safety outcomes. Direct identifiers and the participant identification linkage file will not be shared. Data will be made available through controlled access for approved research proposals, subject to participant consent, institutional and ethics requirements, and applicable data-protection regulations.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tobramycin Nebulization to Prevent Multidrug-Resistant Ventilator-Associated Pneumonia: A Prospective, Multicenter, Double-Blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07856355
- Acronym / sponsor ID
- TOP-MDRVAP / 2026-0634
- Conditions
- Pneumonia, Ventilator-Associated
- Keywords
- Tobramycin, Inhaled Antibiotics, Antibiotic Prophylaxis, Ventilator-Associated Pneumonia, Multidrug-Resistant Bacteria, Invasive Mechanical Ventilation, Critically Ill Patients, Intensive Care Unit
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 574 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Zhejiang University, Sir Run Run Shaw Hospital, The Fourth Affiliated Hospital of Zhejiang University School of Medicine, Zhejiang Hospital, Zhejiang Provincial People's Hospital, Lishui Country People's Hospital, Jinhua People's Hospital, The First People's Hospital of Huzhou, Second Affiliated Hospital of Wenzhou Medical University, Ningbo Medical Center Lihuili Hospital, Qilu Hospital of Shandong University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Zhengzhou Central Hospital, Second Affiliated Hospital of Nanchang University, West China Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine, Weifang People's Hospital, Huang Shan People's Hospital, Jinhua Central Hospital, RenJi Hospital, People's Hospital of Quzhou, Taizhou Hospital, the second people's of kaifeng
- Study start
- 7 Oct 2026 (estimated)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 29 Jan 2029 (estimated)
- First posted
- 2 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The TOP-MDRVAP trial will test whether inhaled tobramycin can safely prevent pneumonia caused by multidrug-resistant bacteria in adults who need a breathing machine. Tobramycin is an antibiotic. Multidrug-resistant bacteria are bacteria that resist treatment with several types of antibiotics. Pneumonia that develops in patients receiving breathing support through a breathing tube is called ventilator-associated pneumonia (VAP). This study will evaluate tobramycin as a preventive treatment, rather than as treatment for existing VAP.
The study plans to enroll 574 adults aged 18 years or older in intensive care units (ICUs) at several hospitals. Participants must have received breathing support through a tube for 72 to 96 hours and be expected to need this support for at least another 72 hours. They must have at least one risk factor for infection with multidrug-resistant bacteria and must not have suspected or confirmed VAP when entering the study.
Participants will be assigned by chance to one of two groups, with an equal chance of entering either group. One group will receive tobramycin inhalation solution, 300 mg in 5 mL, twice daily for 3 consecutive days. The other group will receive 5 mL of 0.9% saline, a saltwater solution containing no antibiotic, on the same schedule. A nebulizer will turn the solution into a fine mist delivered through the breathing tube.
Both groups will receive standard measures to prevent VAP. Participants, their representatives, the healthcare professionals providing their direct care, and the researchers assessing outcomes will not know which study treatment each participant receives.
The main question is whether fewer participants develop VAP caused by multidrug-resistant bacteria within 28 days after assignment to a study group. Researchers will also compare the occurrence of VAP from any cause, antibiotic use, time receiving breathing support, time spent in the ICU and hospital, and deaths within 28 and 90 days.
Participants will be monitored for possible side effects, including kidney problems, narrowing of the airways, and complications involving the breathing tube or equipment. Samples will be tested for bacteria and antibiotic resistance. Follow-up will continue for up to 90 days after assignment, using hospital records or telephone contact to assess survival and recovery milestones, including discharge and the end of breathing support.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomized in a 1:1 ratio to one of two parallel groups: nebulized tobramycin or nebulized 0.9% saline placebo. Both study interventions are administered twice daily for 3 consecutive days.
| Arm | Type | Receives |
|---|---|---|
| Nebulized Tobramycin | Experimental | Drug: Tobramycin inhalation solutionParticipants receive tobramycin inhalation solution, 300 mg in 5 mL per dose, administered through the endotracheal tube using a vibrating mesh nebulizer twice daily for 3 consecutive days (6 planned doses). The intervention is administered to prevent multidrug-resistant ventilator-associated pneumonia (MDR-VAP). Participants also receive standard ventilator-associated pneumonia (VAP) prevention measures. |
| Nebulized 0.9% Sodium Chloride Placebo | Placebo comparator | Drug: 0.9% Sodium Chloride PlaceboParticipants receive 5 mL of 0.9% sodium chloride solution (normal saline) as a placebo, administered through the endotracheal tube using a vibrating mesh nebulizer twice daily for 3 consecutive days (6 planned doses). Participants also receive standard ventilator-associated pneumonia (VAP) prevention measures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥18 years at enrollment.
- Invasive mechanical ventilation through an endotracheal tube for ≥72 hours and ≤96 hours, measured from the time of intubation, with an anticipated requirement for at least another 72 hours of invasive mechanical ventilation, as assessed by the attending physician.
- At least one of the following risk factors for multidrug-resistant (MDR) bacterial infection:
- 3.1 Exposure to systemic antibiotics for ≥24 hours within the 30 days before enrollment.
- 3.2 Current hospitalization for at least 120 hours before randomization. 3.3 Septic shock requiring vasoactive medication to maintain a mean arterial pressure ≥65 mmHg, with a blood lactate level >2 mmol/L.
Key exclusion criteria (10 listed)
- Suspected or confirmed ventilator-associated pneumonia (VAP) on the day of enrollment, based on the attending physician's clinical judgment.
- Continuous invasive mechanical ventilation for more than 96 hours before enrollment.
- Planned extubation within the next 24 hours.
- Previous tracheostomy.
- A history of allergy to tobramycin or any other aminoglycoside antibiotic.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tobramycin inhalation solutionTobramycin inhalation solution (300 mg/5 mL) is administered at a dose of 300 mg (5 mL) twice daily for 3 consecutive days, for a total of 6 planned doses. The ready-to-use solution is administered without additional dilution through the endotracheal tube using a vibrating mesh nebulizer connected to the ventilator circuit. Each nebulization continues until the nebulizer reservoir is empty. The intervention is administered to prevent multidrug-resistant ventilator-associated pneumonia (MDR-VAP), in addition to standard VAP prevention measures. | Drug | Nebulized Tobramycin |
| 0.9% Sodium Chloride PlaceboA 5 mL dose of 0.9% sodium chloride solution (normal saline) is administered as a placebo twice daily for 3 consecutive days, for a total of 6 planned doses. The solution is delivered through the endotracheal tube using the same type of vibrating mesh nebulizer, administration schedule, and nebulization procedure as the tobramycin intervention. Each nebulization continues until the nebulizer reservoir is empty. Participants also receive standard VAP prevention measures. | Drug | Nebulized 0.9% Sodium Chloride Placebo |
Primary outcome
28-Day Cumulative Incidence of Multidrug-Resistant Ventilator-Associated Pneumonia
Time frame: From randomization through Day 28.
Percentage of randomized participants with a first episode of multidrug-resistant ventilator-associated pneumonia (MDR-VAP), adjudicated by an independent blinded endpoint adjudication committee. VAP develops after 48 hours of mechanical ventilation, including within 48 hours after weaning or extubation. Diagnosis requires new or progressive infiltrates, consolidation, or ground-glass opacities on chest X-ray or CT plus at least two of: temperature >38°C, purulent airway secretions, and white blood cell count >10 x 10^9/L or <4 x 10^9/L. MDR-VAP additionally requires a positive quantitative lower respiratory tract culture (tracheal aspirate ≥10^5 CFU/mL; bronchoalveolar lavage ≥10^4 CFU/mL; protected specimen brush ≥10^3 CFU/mL) with a causative bacterium resistant to at least three antimicrobial classes.
16 secondary outcomes
Incidence Density of Multidrug-Resistant Ventilator-Associated Pneumonia
Time frame: From randomization through Day 28.
28-Day Incidence of Ventilator-Associated Pneumonia From Any Cause
Time frame: From randomization through Day 28.
Systemic Antibiotic Use Expressed as Antibiotic-Days
Time frame: From randomization through Day 28.
Days of Exposure to Systemic Antibiotics
Time frame: From randomization through Day 28.
Duration of Mechanical Ventilation
Time frame: From randomization through Day 28.
Intensive Care Unit Length of Stay
Time frame: From randomization to ICU discharge, assessed up to Day 90.
Hospital Length of Stay
Time frame: From randomization to hospital discharge, assessed up to Day 90.
28-Day All-Cause Mortality
Time frame: From randomization through Day 28.
90-Day All-Cause Mortality
Time frame: From randomization through Day 90.
Incidence of Ventilator-Associated Pneumonia Caused by Tobramycin-Susceptible Gram-Negative Bacteria
Time frame: From randomization through Day 28.
Incidence of Ventilator-Associated Events
Time frame: From randomization through Day 28.
Incidence of New-Onset Acute Kidney Injury
Time frame: From randomization through Day 28.
Daily Trajectory of the Clinical Pulmonary Infection Score
Time frame: Assessed daily from randomization until extubation or Day 28, whichever occurs first.
Time to First Successful Spontaneous Breathing Trial
Time frame: From randomization through Day 28.
Detection Rate of Tobramycin-Resistant Bacteria
Time frame: From randomization through Day 28.
Composite Incidence of Serious Nebulization-Related Adverse Effects
Time frame: From randomization through Day 28.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in the primary publication of the TOP-MDRVAP trial will be shared, together with a data dictionary. The dataset will include baseline characteristics, treatment allocation, and data supporting the reported efficacy and safety outcomes. Direct identifiers and the participant identification linkage file will not be shared. Data will be made available through controlled access for approved research proposals, subject to participant consent, institutional and ethics requirements, and applicable data-protection regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tobramycin inhalation solution in people with Pneumonia, Ventilator-Associated, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gensheng Zhang (+86 18806812331, genshengzhang@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-Day Cumulative Incidence of Multidrug-Resistant Ventilator-Associated Pneumonia (time frame: From randomization through Day 28.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.