Ventilator-Associated Pneumonia Due to Carbapenem-Resistant Klebsiella Pneumoniae. Ventilator associated pneumonia
Conditions
Interventions
Intervention 1: Control Group: 44 patients in this group will receive meropenem at a dose of 1 g (in 100 mL of normal saline) three times daily, combined with colistin at a loading dose of 9 million u
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients aged above 18 years. Patients diagnosed with ventilator-associated pneumonia caused by carbapenem-resistant Klebsiella pneumoniae. Presence of the following clinical and paraclinical signs after 48 hours of intubation: new onset fever, increased respiratory secretions, exacerbation of hypoxemia (reduced blood oxygen levels), and leukocytosis (elevated white blood cell count). Presence of radiological findings such as new or progressive infiltrations on chest imaging or CT scan, airspace consolidation, focal opacity, and patchy areas of increased density. Positive culture for carbapenem-resistant Klebsiella pneumoniae based on antibiogram results obtained through one of the following methods: quantitative invasive methods, including bronchoalveolar lavage (BAL) with a colony count of >10,000, mini-BAL with a colony count of >10,000, or protected specimen brush (PSB) with a colony count of >1,000; or non-invasive methods, including endotracheal aspiration with a colony count of >100,000.
Exclusion criteria
Exclusion criteria: Patients with systemic diseases that affect antibiotic dosage. Patients with systemic organ failure (excluding central nervous system failure). Patients with a known allergy to the studied drug components.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main outcome is to measure the overall response rate (ORR) by determining the ratio of patients who achieve a partial or complete response based on VAP and CPIS criteria. Timepoint: Daily. Method of measurement: The Clinical Pulmonary Infection Score (CPIS) is used to measure the primary outcome. This scoring system includes six parameters (body temperature, white blood cell count, tracheal secretions, oxygenation, radiological findings, and microbiological cultures), with a total score ranging from 0 to 12. A score above 6 indicates a higher likelihood of ventilator-associated pneumonia (VAP). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactIlad Alavi Darazam
Shahid Beheshti University of Medical Sciences
Outcome results
None listed