An Early Phase 1 interventional study of Inhaled colistin and Saline in Ventilator Associated Pneumonia ( VAP), sponsored by Ain Shams University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by Ain Shams University · Early Phase 1, Interventional, and Treatment
This study investigates whether adjunctive inhaled colistin enhances clinical recovery and microbiological clearance in multidrug resistant ventilator-associated pneumonia in stroke patients
This will be a prospective, comparative study conducted in the Intensive Care Unit (ICU) of Ain shams university hospitals, over a period of one year. Adult stroke patients diagnosed with ventilator-associated pneumonia (VAP) due to multidrug-resistant Gram-negative bacteria (MDR-GNB) will be screened for eligibility. The diagnosis will be established based on clinical features, radiological evidence, and microbiological confirmation.
Ventilator-associated pneumonia (VAP) is diagnosed based on a combination of clinical, radiological, and microbiological criteria, according to the American thoracic society (ATS)and Infectious diseases society of America(IDSA) guidelines (2016), the diagnosis requires a patient ventilated ≥48 hours with a new or worsening pulmonary infiltrate on chest radiograph, plus at least one of the following: fever or hypothermia, leukocytosis or leukopenia, purulent tracheal secretions, or a decline in oxygenation. Microbiologic confirmation via non-invasive semiquantitative cultures of respiratory secretions is recommended over invasive techniques when feasible.
All patients will receive Ventilator-Associated Pneumonia (VAP) bundle care as part of the standard ICU management .
Eligible patients will be allocated into two groups:
Adults will receive 2.5 mg/kg daily in divided doses every 6 hours for adjunctive treatment of respiratory tract infections .If a 0.5% solution of the drug is prepared using 0.9% sodium chloride and this dosage regimen is used, the average 70-kg patient would receive 6 mL of solution per dose . Adults will receive 500,000 units twice daily given approximately 20 minutes after an oral inhalation dose of a β2-adrenergic agonist.
392 studies on the registry are indexed under Pneumonia, Ventilator-Associated; 81 are open to participants now.
This study's planned enrollment of 78 is below the median of 122 across 254 interventional studies indexed under Pneumonia, Ventilator-Associated.
Browse Pneumonia, Ventilator-Associated studies →Ain Shams University is the lead sponsor of 1,879 studies on the registry; 424 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Inclusion Criteria :adult patients, who were admitted to stroke care unit with the diagnosis of CT or MRI evidenced stroke during the study period with confirmed MDR-GNB pneumonia by culutre and sensitivity requiring intravenous antibiotic therapy, hemodynamically stable at the time of enrollment, and willing to provide informed consent (from legal guardian).
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Exclusion Criteria: Known hypersensitivity to colistin, pregnancy, pre-existing severe renal impairment (CKD stages IV-V or requiring renal replacement therapy), severe immunosuppression, or refusal to participate.
Patients will receive intravenous antibiotics alone, without nebulized colistin plus inhaled saline. Standred intravenous antibiotics will be given according to culture and sensitivity and ICU protocol.
Drug: Saline
Patients will receive nebulized colistin in addition to standard intravenous antibiotics according to ICU protocol. Adults will receive 2.5 mg/kg daily in divided doses every 6 hours for adjunctive treatment of respiratory tract infections .If a 0.5% solution of the drug is prepared using 0.9% sodium chloride and this dosage regimen is used, the average 70-kg patient would receive 6 mL of solution per dose( Karaiskos I, et al.2023) . Adults will receive 500,000 units twice daily given approximately 20 minutes after an oral inhalation dose of a β2-adrenergic agonist.
Drug: Inhaled colistin
group B will recieve inhaled colistin with intravenous antibiotics and group A will recieve the intravenous antibiotics with inhaled saline
group A will recieve the intravenous antibiotics with inhaled saline
primary outcome is the clinical response
Clinical outcome was classified as clinical cure, clinical improvement, and clinical failure according to clinical pulmonary infection score (CPIS) (Mondal, M.K. and Dutta, S., 2025). Acute phase reactants (CRP and procalcitonin) will be assessed every 48 hours, while serum lactate will be measured daily to monitor the patient's metabolic status and response to therapy to correlate their trends with clinical outcomes. Clinical pulmonary infection score (CPIS): The CPIS will be calculated at baseline and on Daily basis of therapy, using six components (temperature, blood leukocyte count, tracheal secretions, PaO₂/FiO₂ ratio, chest radiograph, and tracheal aspirate culture), with scores ranging from 0-12. Parameter 0 points 1 point 2 points Temperature (°C) 36.5-38.4 38.5-38.9 or 36.0-36.4 ≥39.0 or ≤35.9 Blood leukocytes (cells/µL) 4,000-11,000 \<4,000 or \>11,000 \<4,000 or \>11,000 plus band forms ≥50% Tracheal secretions Rare Abundant Abundant + purulent PaO₂/FiO₂ ratio (mmHg) \>240 o
Time frame: two weeks from the start
Microbiological eradication
* Eradication of the pathogen: No pathogen growth was observed in the final culture of specimens following colistin treatment. * Persistence of the pathogen: Continued growth of the identified pathogen in culture after colistin treatment. * Recurrence (regrowth) of the pathogen: Isolation of the same pathogen identified in the initial culture following subsequent negative cultures during colistin treatment.
Time frame: two weeks from the start
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Pneumonia, Ventilator-Associated→
Ain Shams University