About this trial
This study investigates whether adjunctive inhaled colistin enhances clinical recovery and microbiological clearance in multidrug resistant ventilator-associated pneumonia in stroke patients
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Patients with cultures sensitive to colistin will be excluded.
Trial design
Parallel
Treatments tested in this trial
Inhaled colistin
Druggroup B will recieve inhaled colistin with intravenous antibiotics and group A will recieve the intravenous antibiotics with inhaled saline
Saline
Druggroup A will recieve the intravenous antibiotics with inhaled saline
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
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.
Locations
Sponsors and contacts
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