Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 4:39 PM
Study NCT ID:
NCT07409727
Status:
RECRUITING
Last Update Posted:
2026-03-10
First Post:
2026-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Acetylcysteine Inhalation on Incidence and Time to Develop Ventilator Associated Pneumonia in Critically Ill Mechanically Ventilated Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000111', 'term': 'Acetylcysteine'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D003545', 'term': 'Cysteine'}, {'id': 'D000603', 'term': 'Amino Acids, Sulfur'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2028-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-07', 'studyFirstSubmitDate': '2026-02-02', 'studyFirstSubmitQcDate': '2026-02-08', 'lastUpdatePostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary endpoint of interest is incidence and time to develop ventilator associated pneumonia.', 'timeFrame': 'participant will be followed up for 10 days post mechanical ventilation or till extubation (whichever occurs first).', 'description': '1. Incidence of VAP will be expressed as percentage of patients who developed VAP.\n2. Time to develop VAP is expressed in days'}], 'secondaryOutcomes': [{'measure': '1) Infection parameters (TLC,Temperature °C) 2)Change in P/F ratio 3) Duration of mechanical ventilation expressed in days 3) Day 3 ETT aspirate culture positivity 4) Number of endotracheal tube exchange and suctioning episodes per ventilator day.', 'timeFrame': 'participant will be followed up for 10 days post mechanical ventilation or till extubation (whichever occurs first)', 'description': '1. Change in infection parameter TLC (×10⁹/L), CRP (mg/L), body temperature (°C) from base line to day 10 post intubation or till extubation\n2. Change in (P/F ratio measured in mmHg) from baseline to day 10 post intubation or till extubation\n3. Positive vs negative ETA culture'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ventilation Acquired Pneumonia']}, 'descriptionModule': {'briefSummary': '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.\n\nVentilator-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.\n\nSecretion 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.\n\nFor 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.\n\nNAC 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.\n\nContrary to other mucoactive drugs, NAC has been found to exhibit antioxidant, anti-inflammatory, antibacterial, and antibiofilm activities.\n\nIn 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.\n\nNAC 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\nN-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.\n\nSince 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.\n\nAim of the study\n\nThis study will assess the role of preventive N-acetylcysteine inhalation on incidence and time to develop VAP in critically ill mechanically ventilated patients.\n\nObjectives\n\n* 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\n* 2\\) Assessment of the safety of N-acetylcysteine inhalation in mechanically ventilated patients by monitoring the incidence of new-onset bronchospasm'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged 18-64 years, either male or female.\n2. Critically ill patients who have undergone intubation and are on mechanical ventilation.\n3. Expected duration of mechanical ventilation of more than 48 hours.\n4. Provided consent to participate in this clinical trial by next of kin.\n\nExclusion Criteria:\n\n1. Patients currently on long-term NAC treatment.\n2. Confirmed brain death.\n3. Recent chest infection.\n4. Immunocompromised patients on immunosuppressive medication.\n5. Patients mechanically ventilated in another hospital.\n6. Pregnant women.\n7. Mean arterial pressure (MAP) \\<60 mmHg despite adequate resuscitation and vasopressor therapy at the time of randomization.\n8. Known intolerance or hypersensitivity to study medication.\n9. Presence of a condition or abnormality that would compromise the quality of the data.\n\n \\-'}, 'identificationModule': {'nctId': 'NCT07409727', 'briefTitle': 'Effect of Acetylcysteine Inhalation on Incidence and Time to Develop Ventilator Associated Pneumonia in Critically Ill Mechanically Ventilated Patients', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'The Role of N-Acetylcysteine Inhalation in Critically Ill Mechanically Ventilated Patients', 'orgStudyIdInfo': {'id': 'N-364-2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '40 adults patients receiving normal saline 0.9% inhalation every 12hrs', 'interventionNames': ['Drug: Normal (0.9%) saline']}, {'type': 'EXPERIMENTAL', 'label': '40 adult patients will recieve acetyl cysteine 10% nebulizer every 12 hrs', 'interventionNames': ['Drug: Acetyl cysteine']}], 'interventions': [{'name': 'Acetyl cysteine', 'type': 'DRUG', 'description': '40 adult mechanically ventilated patients will receive acetyl cysteine nebulizer 10% every 12 hours', 'armGroupLabels': ['40 adult patients will recieve acetyl cysteine 10% nebulizer every 12 hrs']}, {'name': 'Normal (0.9%) saline', 'type': 'DRUG', 'description': '40 adult mechanically ventilated patients will receive normal saline nebulizer every 12 hours', 'armGroupLabels': ['40 adults patients receiving normal saline 0.9% inhalation every 12hrs']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11011', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Sarah Adly', 'role': 'CONTACT', 'email': 'Sarah.adly@pharma.asu.edu.eg', 'phone': '01116485082'}], 'facility': 'Cairo University Hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'city': 'Cairo', 'status': 'NOT_YET_RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Maggie M Abbassi', 'role': 'CONTACT', 'email': 'maggie.abbassi@pharma.cu.edu.eg', 'phone': '00201001589925'}], 'facility': 'Cairo University Hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Maggie M Abbassi, professor of clinical pharmacy', 'role': 'CONTACT', 'email': 'Maggie.abbassi@pharma.cu.edu.eg', 'phone': '00201001589925'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sarah Rabie Mohamed Adly', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'clinical pharmacist', 'investigatorFullName': 'Sarah Rabie Mohamed Adly', 'investigatorAffiliation': 'Cairo University'}}}}