Inhaled acetylcysteine to prevent pneumonia in adults on mechanical ventilation

The Role of N-Acetylcysteine Inhalation in Critically Ill Mechanically Ventilated Patients

This trial tests whether breathing in acetylcysteine instead of saline can lower the chance of getting ventilator-associated pneumonia or delay when it starts in adults on a ventilator.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 64 Years
• Sex: All
• Sponsor: Cairo University (Academic / other)
• Locations: 2 sites (Cairo and 1 other locations)
• Trial ID: NCT07409727 on ClinicalTrials.gov

What this trial studies

Critically ill adults who are intubated and expected to need mechanical ventilation for more than 48 hours will receive inhaled acetylcysteine or inhaled normal saline while in the ICU. The trial monitors whether acetylcysteine changes the incidence of ventilator-associated pneumonia and the time until pneumonia develops. Key exclusions include patients already on long-term NAC, those who are pregnant, immunocompromised, brain dead, or hemodynamically unstable. Outcomes include infection rates and timing of ventilator-associated complications during the ICU stay.

Who should consider this trial

Good fit: Adult (18–64) critically ill patients who are intubated, expected to require mechanical ventilation for more than 48 hours, and whose next of kin can provide consent are the intended participants.

Not a fit: Patients already on long-term NAC, those who are pregnant, immunocompromised, brain dead, hemodynamically unstable (MAP <60 mmHg despite support), or ventilated at another hospital are excluded and unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, inhaled acetylcysteine could reduce ventilator-associated pneumonia and shorten time on the ventilator and in the ICU.

How similar studies have performed: Prior small trials and observational studies of inhaled mucolytics including N-acetylcysteine have shown mixed and limited evidence for preventing ventilator-associated pneumonia, so effectiveness is not yet established.

Eligibility criteria

Inclusion Criteria:

1. Aged 18-64 years, either male or female.
2. Critically ill patients who have undergone intubation and are on mechanical ventilation.
3. Expected duration of mechanical ventilation of more than 48 hours.
4. Provided consent to participate in this clinical trial by next of kin.

Exclusion Criteria:

1. Patients currently on long-term NAC treatment.
2. Confirmed brain death.
3. Recent chest infection.
4. Immunocompromised patients on immunosuppressive medication.
5. Patients mechanically ventilated in another hospital.
6. Pregnant women.
7. Mean arterial pressure (MAP) \<60 mmHg despite adequate resuscitation and vasopressor therapy at the time of randomization.
8. Known intolerance or hypersensitivity to study medication.
9. Presence of a condition or abnormality that would compromise the quality of the data.

   \-

Where this trial is running

Cairo and 1 other locations

• Cairo University Hospitals — Cairo, Egypt (Recruiting)
• Cairo University Hospitals — Cairo, Egypt (Not_yet_recruiting)

Study contacts

• Study coordinator: Maggie M Abbassi, professor of clinical pharmacy

Conditions Ventilation Acquired Pneumonia