Treatment-resistant ventilator-associated pneumonia. Ventilator associated pneumonia
Conditions
Interventions
Intervention 1: Intervention group no. 1: IV colistin (loading dose: 9 million IU once, followed by maintenance dose: 4.5 million IU every 12 hours for 10–14 days). Intervention 2: Intervention group
Sponsors
Yazd University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Age 18–65 years. ICU admission with clinical and radiologic diagnosis of VAP according to guidelines Positive culture from respiratory secretions or BAL showing MDR organism sensitive to colistin Mechanical ventilation for at least 48 hours before symptom onset Written informed consent obtained from the patient’s legal guardian
Exclusion criteria
Exclusion criteria: Fever during the first 48 hours of hospital admission Severe renal failure (GFR <30 mL/min/1.73 m²) or need for dialysis Decompensated heart failure Severe hepatic failure Severe respiratory disease with structural lung abnormalities (bronchiectasis, pulmonary fibrosis, severe emphysema, etc.). Acquired (e.g., HIV+) or congenital immunodeficiency Active malignancy under chemotherapy within the past six months Known hypersensitivity to polymyxins Pregnancy or breastfeeding Life expectancy <72 hours Refractory septic shock Positive culture for Gram-positive microorganisms
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Microbiological culture of respiratory secretions. Timepoint: On days 7, 10, and 14. Method of measurement: Culture media, incubator, and microscope. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Pulmonary Infection Score. Timepoint: On day 7, 10 and 14. Method of measurement: Clinical Pulmonary Infection Score is calculated by evaluating six parameters: body temperature, white blood cell count, tracheal secretions, oxygenation (PaO2/FiO2), chest radiograph findings, and culture results of respiratory secretions, with a total score (0–12) used to assess the diagnosis and severity of pneumonia.;Core body temperature. Timepoint: On day 7, 10 and 14. Method of measurement: Measurement of core body temperature using a rectal probe.;Sequential Organ Failure Assessment score. Timepoint: On day 7, 10 and 14. Method of measurement: This score is calculated by evaluating the function of six major organ systems (lungs, liver, kidneys, cardiovascular system, brain, and coagulation) based on clinical and laboratory parameters.;Acute Physiology and Chronic Health Evaluation score. Timepoint: On day 7, 10 and 14. Method of measurement: The Acute Physiology and Chronic Health Evaluation score is calculated using acute physiological data, patient age, and chronic health conditions to predict disease severity and risk of death in intensive care unit patients.;White blood cell count. Timepoint: On day 7, 10 and 14. Method of measurement: White blood cell count is measured using a complete blood count test with an automated hematology analyzer.;Erythrocyte sedimentation rate levels. Timepoint: On day 7, 10 and 14. Method of measurement: The erythrocyte sedimentation rate is measured using a blood test with the Westergren method.;C-reactive protein levels. Timepoint: On day 7, 10 and 14. Method of measurement: Acute-phase protein levels are measured using a blood test with immunological or chemical methods, such as ELISA.;Incidence of new renal failure. Timepoint: On day 7, 10 and 14. Method of measurement: Measuring serum creatinine and monitoring urine output over a specified time period to diagnose and stage acute kidney injury.;28-day mortality. Timepoint: On day 7 | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactFatemeh Davoudi Semiromi
Yazd University of Medical Sciences
Outcome results
None listed