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New treatment option for Ventilator-Associated Pneumonia (VAP)
Official title Colistin Methanesulfonate Sodium Inhalation for Prophylaxis of Ventilator-Associated Pneumonia (CIVAP): A Prospective, Multicentre, Double-Blind, Randomized, Placebo-Controlled Trial
ClinicalTrials.gov ID: NCT06834971
What this study is testing
What is Colistimethate sodium (CMS)?
Colistimethate sodium (CMS) is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for ventilator-associated pneumonia (vap).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants will be enrolled if they meet the following criteria:
- Age ≥18 years;
- Mechanical ventilation for more than two consecutive days (48 hours);
- Patient has high-risk factors for multidrug-resistant bacterial infections, which meet any of the following criteria: (1)History of antibiotic...
- Suspected or confirmed VAP at the inclusion day;
See the full eligibility criteria
- Participants will be enrolled if they meet the following criteria:
- Age ≥18 years;
- Mechanical ventilation for more than two consecutive days (48 hours);
- 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)...
- Suspected or confirmed VAP at the inclusion day;
- Patient ventilated through an endotracheal tube for more than four consecutive days (96 hours);
- Expected that endotracheal intubation will be removed within the next 24 hours;
- Tracheostomy;
- Allergy to CMS;
- Patients has polymyxins medication history within 7 days or clinical indication for systemic CMS therapy at the inclusion day;
- Chronic kidney failure with baseline glomerular filtration ≤30 mL/min or Stage 3 classification AKI (KDIGO) (excluding patients undergoing renal replacement therapy);
- Expected survival time not exceeding 48 hours;
- Pregnancy or breastfeeding period;
- Patients previously included in this study or are using any inhaled antibiotics or are participating in other clinical studies within 30 days.
The study team makes the final eligibility decision.
Where it's taking place
- Jinan, Shandong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jinan, Shandong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.