Role of Inhaled Polymyxin as an Adjunct to Intravenous Therapy in Multidrug Resistant Ventilator-associated Pneumonia in Stroke Patients

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAin Shams University

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 volunteers

Qualifiers

None

Disqualifiers

Patients with cultures sensitive to colistin will be excluded.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Inhaled colistin

    Drug

    group B will recieve inhaled colistin with intravenous antibiotics and group A will recieve the intravenous antibiotics with inhaled saline

  • Saline

    Drug

    group A will recieve the intravenous antibiotics with inhaled saline

Treatment groups

78 Participants
are divided into 2 treatment groups
Group A: control group APlacebo comparator 1 intervention
Group B: intervention group BExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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