Ventilation Acquired PneumoniaPhase 4NCT07409727
Effect of Acetylcysteine Inhalation on Incidence and Time to Develop Ventilator Associated Pneumonia in Critically Ill Mechanically Ventilated Patients
A Phase 4 study testing Acetyl cysteine and Normal (0.9%) saline in people with Ventilation Acquired Pneumonia, run by Cairo University at 1 site in Egypt.
Trial summary
Background Mechanical ventilation is an essential medical intervention in the context of critical illness. However, the intervention is associated with a risk of significant, potentially preventable complications. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Ventilation Acquired Pneumonia
- What is being tested?
- Acetyl cysteine and Normal (0.9%) saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2026to 1 Jun 2028
- 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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18-64 years, either male or female.
- Critically ill patients who have undergone intubation and are on mechanical ventilation.
- Expected duration of mechanical ventilation of more than 48 hours.
- Provided consent to participate in this clinical trial by next of kin.
Who cannot join
- Patients currently on long-term NAC treatment.
- Confirmed brain death.
- Recent chest infection.
- Immunocompromised patients on immunosuppressive medication.
- Patients mechanically ventilated in another hospital.
- Pregnant women.
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- Mean arterial pressure (MAP) <60 mmHg despite adequate resuscitation and vasopressor therapy at the time of randomization.
- Known intolerance or hypersensitivity to study medication.
- Presence of a condition or abnormality that would compromise the quality of the data.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Maggie M Abbassi, professor of clinical pharmacy contact
Egypt1 site, 1 recruiting
- Recruiting
Cairo University Hospitals
Cairo, 11011
Sarah Adly, 01116485082, Sarah.adly@pharma.asu.edu.eg
About this study
Official title: The Role of N-Acetylcysteine Inhalation in Critically Ill Mechanically Ventilated Patients
Background Mechanical ventilation is an essential medical intervention in the context of critical illness. However, the intervention is associated with a risk of significant, potentially preventable complications. Among these are ventilator-associated pneumonia, sepsis, acute respiratory distress syndrome, atelectasis, and pulmonary edema.
Ventilator-associated complications commonly increase morbidity and mortality. They may also prolong the duration of mechanical ventilation and the length of stay in the hospital or the intensive care unit, with increased health care costs; so safe, effective therapeutic and preventative strategies are essential to attenuate poor outcomes from ventilator-associated events.
Read more
Secretion retention and ineffective cough play a significant role in failed extubation and weaning from ventilator; the presence of the artificial airway, poor humidification of inspired gases, and immobility are the major causes of pulmonary secretion retention in this population. Accumulated secretion in the airways, if extensive, starts a self-sustaining cycle of ventilation/perfusion mismatch, gas-exchange impairment, increased work of breathing.
For decades N-acetyl-L-cysteine (NAC) has been used for its mucolytic properties orally in different respiratory diseases like chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis (IPF) and cystic fibrosis (CF); but its effects are not known if given by nebulization through endotracheal tube (ETT), studies to date have provided inconclusive results. Despite this uncertainty, mucoactive agents are still used in adult ICUs.
NAC is usually administered orally, with several formulations and dosage forms available for both short- and long-term treatment of respiratory diseases. The inhalation route might also be considered a practical option, with recent interest, as the therapeutic drug acts directly on the bronchial mucosa, promotes continuous local retention of the drug, prolongs anti-inflammatory effects, and avoids the liver first-pass effect, which can help quickly improve airway inflammation.
Contrary to other mucoactive drugs, NAC has been found to exhibit antioxidant, anti-inflammatory, antibacterial, and antibiofilm activities.
In the respiratory infection field, the available data indicate that NAC was associated with inhibition of oxidative stress and reduced the inflammatory factors in community acquired pneumonia, antibiofilm activity specially in pseudomonas aeruginosa infection in pre-clinical and clinical reports and has good antibacterial properties and suggested to interfere with biofilm formation and disruption.
NAC has shown improvement in the respiratory index (PaO₂/FiO₂), with lower rates of mechanical ventilation in COVID-19. When studied in mechanically ventilated patients with acute respiratory distress syndrome (ARDS), which is associated with oxidative stress, increased levels of glutathione, and inflammation, NAC demonstrated improvements in positive end-expiratory pressure (PEEP) and PaO₂/FiO₂.
N-Acetylcysteine contributed to delaying ventilator-associated pneumonia (VAP) in mechanically ventilated patients when administered orally as a preventive medication. It was also effective in attenuating the decline in forced vital capacity (FVC) in mild to moderate idiopathic pulmonary fibrosis (IPF), and it showed a lower rate of postoperative pulmonary complications when given pre-operatively in orthotopic liver transplantation.
Since NAC is relatively low-cost, readily available, and has a favorable side effect profile, it is important to properly assess the clinical benefits of nebulized NAC as an adjunct to standard medical treatments in mechanically ventilated patients.
Aim of the study
This study will assess the role of preventive N-acetylcysteine inhalation on incidence and time to develop VAP in critically ill mechanically ventilated patients.
Objectives
- 1) Assessment of N-acetylcysteine inhalation efficacy in mechanically ventilated patients through monitoring the following parameters: time to develop ventilator-associated pneumonia (VAP), incidence of VAP, PaO₂/FiO₂, pH, oxygen saturation (SaO₂), peak inspiratory pressure (PIP), positive end-expiratory pressure (PEEP), frequency of endotracheal tube (ETT) suction and tube exchange, and infection parameters (total leukocyte count, body temperature). In addition, hospital mortality, duration of mechanical ventilation (MV), ventilator-free days, and the length of hospital and ICU stay
- 2) Assessment of the safety of N-acetylcysteine inhalation in mechanically ventilated patients by monitoring the incidence of new-onset bronchospasm
- Conditions
- Ventilation Acquired Pneumonia
- Being tested
- Acetyl cysteine, Normal (0.9%) saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetyl cysteineDrug
40 adult mechanically ventilated patients will receive 3ml acetyl cysteine 10% nebulised every 12 hours .Nebulization will be performed using a vibrating mesh nebulizer ( Aerogen solo) placed in the inspiratory limb of the ventilator tubing, behind the Y-piece, and continued until the nebulizer deposit becomes dry.
Normal (0.9%) salineDrug
40 adult mechanically ventilated patients will receive 3ml normal saline nebulised every 12 hours. Nebulization will be performed using a vibrating mesh nebulizer (Aerogen solo) placed in the inspiratory limb of the ventilator tubing, behind the Y-piece, and continued until the nebulizer deposit becomes dry
| Study group | Role | What they receive |
|---|---|---|
| 40 adult patients receiving 3ml normal saline 0.9% inhalation every 12hrs. | Active comparator | 40 adult patients receiving 3ml normal saline 0.9% inhalation every 12hrs using Aerogen solo nebulizers Receives: Drug: Normal (0.9%) saline |
| 40 adult patients will recieve 3ml acetyl cysteine 10% nebulizer every 12 hrs | Experimental | 40 adults patients receiving 3ml acetylcysteine inhalation every 12hrs using Aerogen solo nebulizers. Receives: Drug: Acetyl cysteine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint of interest is incidence and time to develop ventilator associated pneumonia.
- Incidence of VAP will be expressed as percentage of patients who developed VAP.
- Time to develop VAP is expressed in days
Measured: participant will be followed up for 10 days post mechanical ventilation or till extubation (whichever occurs first).
Secondary outcomes (1)
1) Infection parameters (TLC,Temperature °C) 2)Change in P/F ratio 3) Duration of mechanical ventilation expressed in days 4) Day 3 ETT aspirate culture positivity 5) Number of endotracheal tube exchange and suctioning episodes per ventilator day.
- Change in infection parameter TLC (×10⁹/L), CRP (mg/L), body temperature (°C) from base line to day 10 post intubation or till extubation
- Change in (P/F ratio measured in mmHg) from baseline to day 10 post intubation or till extubation
- Positive vs negative ETA culture
- Incidence and time to develop Ventilator associated tracheobronchitis.
Measured: participant will be followed up for 10 days post mechanical ventilation or till extubation (whichever occurs first)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start1 Mar 2026
- Primary completionMar 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilation Acquired PneumoniaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Aerogen
- Responsible party
- Principal investigator, Sarah Rabie Mohamed Adly, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07409727
- Sponsor's protocol ID
- N-364-2025
- Status last verified
- Jul 2026
- First submitted
- 2 Feb 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of N-Acetylcysteine Inhalation in Critically Ill Mechanically Ventilated Patients
- ClinicalTrials.gov ID
- NCT07409727
- Acronym / sponsor ID
- N-364-2025
- Conditions
- Ventilation Acquired Pneumonia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Aerogen
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 13 Feb 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.
Background Mechanical ventilation is an essential medical intervention in the context of critical illness. However, the intervention is associated with a risk of significant, potentially preventable complications. Among these are ventilator-associated pneumonia, sepsis, acute respiratory distress syndrome, atelectasis, and pulmonary edema.
Ventilator-associated complications commonly increase morbidity and mortality. They may also prolong the duration of mechanical ventilation and the length of stay in the hospital or the intensive care unit, with increased health care costs; so safe, effective therapeutic and preventative strategies are essential to attenuate poor outcomes from ventilator-associated events.
Secretion retention and ineffective cough play a significant role in failed extubation and weaning from ventilator; the presence of the artificial airway, poor humidification of inspired gases, and immobility are the major causes of pulmonary secretion retention in this population. Accumulated secretion in the airways, if extensive, starts a self-sustaining cycle of ventilation/perfusion mismatch, gas-exchange impairment, increased work of breathing.
For decades N-acetyl-L-cysteine (NAC) has been used for its mucolytic properties orally in different respiratory diseases like chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis (IPF) and cystic fibrosis (CF); but its effects are not known if given by nebulization through endotracheal tube (ETT), studies to date have provided inconclusive results. Despite this uncertainty, mucoactive agents are still used in adult ICUs.
NAC is usually administered orally, with several formulations and dosage forms available for both short- and long-term treatment of respiratory diseases. The inhalation route might also be considered a practical option, with recent interest, as the therapeutic drug acts directly on the bronchial mucosa, promotes continuous local retention of the drug, prolongs anti-inflammatory effects, and avoids the liver first-pass effect, which can help quickly improve airway inflammation.
Contrary to other mucoactive drugs, NAC has been found to exhibit antioxidant, anti-inflammatory, antibacterial, and antibiofilm activities.
In the respiratory infection field, the available data indicate that NAC was associated with inhibition of oxidative stress and reduced the inflammatory factors in community acquired pneumonia, antibiofilm activity specially in pseudomonas aeruginosa infection in pre-clinical and clinical reports and has good antibacterial properties and suggested to interfere with biofilm formation and disruption.
NAC has shown improvement in the respiratory index (PaO₂/FiO₂), with lower rates of mechanical ventilation in COVID-19. When studied in mechanically ventilated patients with acute respiratory distress syndrome (ARDS), which is associated with oxidative stress, increased levels of glutathione, and inflammation, NAC demonstrated improvements in positive end-expiratory pressure (PEEP) and PaO₂/FiO₂.
N-Acetylcysteine contributed to delaying ventilator-associated pneumonia (VAP) in mechanically ventilated patients when administered orally as a preventive medication. It was also effective in attenuating the decline in forced vital capacity (FVC) in mild to moderate idiopathic pulmonary fibrosis (IPF), and it showed a lower rate of postoperative pulmonary complications when given pre-operatively in orthotopic liver transplantation.
Since NAC is relatively low-cost, readily available, and has a favorable side effect profile, it is important to properly assess the clinical benefits of nebulized NAC as an adjunct to standard medical treatments in mechanically ventilated patients.
Aim of the study
This study will assess the role of preventive N-acetylcysteine inhalation on incidence and time to develop VAP in critically ill mechanically ventilated patients.
Objectives
- 1) Assessment of N-acetylcysteine inhalation efficacy in mechanically ventilated patients through monitoring the following parameters: time to develop ventilator-associated pneumonia (VAP), incidence of VAP, PaO₂/FiO₂, pH, oxygen saturation (SaO₂), peak inspiratory pressure (PIP), positive end-expiratory pressure (PEEP), frequency of endotracheal tube (ETT) suction and tube exchange, and infection parameters (total leukocyte count, body temperature). In addition, hospital mortality, duration of mechanical ventilation (MV), ventilator-free days, and the length of hospital and ICU stay
- 2) Assessment of the safety of N-acetylcysteine inhalation in mechanically ventilated patients by monitoring the incidence of new-onset bronchospasm
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 40 adult patients receiving 3ml normal saline 0.9% inhalation every 12hrs. | Active comparator | Drug: Normal (0.9%) saline40 adult patients receiving 3ml normal saline 0.9% inhalation every 12hrs using Aerogen solo nebulizers |
| 40 adult patients will recieve 3ml acetyl cysteine 10% nebulizer every 12 hrs | Experimental | Drug: Acetyl cysteine40 adults patients receiving 3ml acetylcysteine inhalation every 12hrs using Aerogen solo nebulizers. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Aged 18-64 years, either male or female.
- Critically ill patients who have undergone intubation and are on mechanical ventilation.
- Expected duration of mechanical ventilation of more than 48 hours.
- Provided consent to participate in this clinical trial by next of kin.
Key exclusion criteria (10 listed)
- Patients currently on long-term NAC treatment.
- Confirmed brain death.
- Recent chest infection.
- Immunocompromised patients on immunosuppressive medication.
- Patients mechanically ventilated in another hospital.
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 |
|---|---|---|
| Acetyl cysteine40 adult mechanically ventilated patients will receive 3ml acetyl cysteine 10% nebulised every 12 hours .Nebulization will be performed using a vibrating mesh nebulizer ( Aerogen solo) placed in the inspiratory limb of the ventilator tubing, behind the Y-piece, and continued until the nebulizer deposit becomes dry. | Drug | 40 adult patients will recieve 3ml acetyl cysteine 10% nebulizer every 12 hrs |
| Normal (0.9%) saline40 adult mechanically ventilated patients will receive 3ml normal saline nebulised every 12 hours. Nebulization will be performed using a vibrating mesh nebulizer (Aerogen solo) placed in the inspiratory limb of the ventilator tubing, behind the Y-piece, and continued until the nebulizer deposit becomes dry | Drug | 40 adult patients receiving 3ml normal saline 0.9% inhalation every 12hrs. |
Primary outcome
The primary endpoint of interest is incidence and time to develop ventilator associated pneumonia.
Time frame: participant will be followed up for 10 days post mechanical ventilation or till extubation (whichever occurs first).
1. Incidence of VAP will be expressed as percentage of patients who developed VAP. 2. Time to develop VAP is expressed in days
1 secondary outcome
1) Infection parameters (TLC,Temperature °C) 2)Change in P/F ratio 3) Duration of mechanical ventilation expressed in days 4) Day 3 ETT aspirate culture positivity 5) Number of endotracheal tube exchange and suctioning episodes per ventilator day.
Time frame: participant will be followed up for 10 days post mechanical ventilation or till extubation (whichever occurs first)
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 10 Jul 2026.
- Individual participant dataSharing planned: Yes
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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.
Maggie M Abbassi, professor of clinical pharmacy contact
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 Acetyl cysteine and Normal (0.9%) saline in people with Ventilation Acquired Pneumonia, run by Cairo University at 1 site in Egypt.
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 4 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: looking for participants now, as of the sponsor's last update on 10 Jul 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 Egypt. 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. 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 Maggie M Abbassi, professor of clinical pharmacy (00201001589925, Maggie.abbassi@pharma.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint of interest is incidence and time to develop ventilator associated pneumonia. (time frame: participant will be followed up for 10 days post mechanical ventilation or till extubation (whichever occurs first).). 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 10 Jul 2026.