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Colistin Methanesulfonate Sodium Inhalation for Prophylaxis of Ventilator-Associated Pneumonia (CIVAP): A Prospective, Multicentre, Double-Blind, Randomized, Placebo-Controlled Trial

RecruitingNAAges 18 Years - anyAllQilu Hospital of Shandong University
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In plain words

What the trial is, and whether it could suit you

Previous studies have identified Acinetobacter baumannii (AB), Pseudomonas aeruginosa (PA), and Klebsiella pneumoniae (KP) as the predominant pathogens responsible for ventilator-associated pneumonia (VAP). The challenge of drug resistance, especially against carbapenem is intensifying, with variations noted across different regions. Multidrug-resistant organisms associated VAP (MDR-VAP) are increasing in frequency and are associated with significant morbidity, mortality, therefore imposes a heavy burden on the healthcare system. Colistin methanesulfonate sodium (CMS) has shown effectiveness against gram-negative bacteria, including carbapenem-resistant organisms (CRO) such as carbapenem-resistant Acinetobacter baumannii (CRAB), carbapenem-resistant Pseudomonas aeruginosa (CRPA), and carbapenem-resistant Klebsiella pneumoniae (CRKP). This trial aims to evaluate the efficacy of a 3-day co

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Participants will be enrolled if they meet the following criteria: 1. Age โ‰ฅ18 years; 2. Mechanical ventilation for more than two consecutive days (48 hours); 3. Patient has high-risk factors for multidrug-resistant bacterial infections, which meet any of the following criteria: (1)History of antibiotic exposure within 30 days; (2)Hospitalization time\>5 days (120 hours); (3)Septic shock; (4) ARDS; (5)Accept renal replacement therapy; (6)Previous colonization of multidrug-resistant bacteria; 4. Informed consent of the patient or a proxy was written. Participants will be excluded in case of: 1. Suspected or confirmed VAP at the inclusion day; 2. Patient ventilated through an endotracheal tube for more than four consecutive days (96 hours); 3. Expected that endotracheal intubation will be removed within the next 24 hours; 4. Tracheostomy; 5. Allergy to CMS; 6. Patients has polymyxins medication history within 7 days or clinical indication for systemic CMS therapy at the inclusion day; 7. Chronic kidney failure with baseline glomerular filtration โ‰ค30 mL/min or Stage 3 classification AKI (KDIGO) (excluding patients undergoing renal replacement therapy); 8. Expected survival time not exceeding 48 hours; 9. Pregnancy or breastfeeding period; 10. Patients previously included in this study or are using any inhaled antibiotics or are participating in other clinical studies within 30 days.
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What it tests

  • Colistimethate sodium (CMS)
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Where

1 site
Qilu Hospital of Shandong university
Jinan, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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