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Comparing Fixed Dose and Weight-Based Colistin Treatments for Multidrug-Resistant Gram-Negative Infections in Critically Ill Patients
Led by Mansoura University · Updated on 2025-07-04
120
Participants Needed
1
Research Sites
4 weeks
Total Duration
AI-Summary
What this Trial Is About
This research evaluates the effectiveness and safety of two dosing methods for colistin, an antibiotic used to treat infections caused by multi-drug-resistant and extensively drug-resistant Gram-negative bacteria in critically ill patients. These infections, especially common in intensive care units, pose a significant threat due to increasing antibiotic resistance, particularly in Saudi Arabia. The study focuses on comparing fixed dose and weight-based dose strategies in both obese and non-obese patients. Participants will be randomly assigned to one of two groups. One group receives intravenous colistin using a fixed dose strategy based on creatinine clearance, with a loading dose of 9 MIU equal to 300 mg of colistin base activity followed by maintenance doses every 12 hours. The other group receives colistin dosed based on body weight, with a loading dose calculated as four times the patients weight in kilograms, which may exceed 300 mg. Both dosing strategies will be administered intravenously in the intensive care unit setting. During the study, patients will be monitored for clinical and microbiological success in eliminating infections, assessed 14 days after starting colistin treatment. Safety will also be closely watched, particularly for kidney-related side effects. Researchers will collect data on how well the infection is cleared and observe any toxic effects from the treatment. The trial will last throughout the treatment period and follow-up to assess outcomes and safety in critically ill patients.
CONDITIONS
Brief Title
Different Dosing Strategies of Colistin in Multidrug-Resistant Gram-Negative Bacilli Infections
Research Team
A
Abdulmajeed S Alharbi, Master
M
Mona M El-Tamalawy, Master
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