Different dosing strategies of colistin for treating infections from drug-resistant bacteria
Efficacy and Safety of Different Dosing Strategies of Colistin in Multidrug-Resistant Gram-Negative Bacilli Infections in Critically Ill Patients
This study tests different ways to give colistin, a last-resort antibiotic, to see which method works best for critically ill patients with infections from drug-resistant bacteria.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mansoura University Academic / other |
| Locations | 1 site (Buraidah) |
| Trial ID | NCT06843668 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates various dosing strategies of colistin, a last-resort antibiotic, to treat infections caused by multidrug-resistant Gram-negative bacteria in critically ill patients. The study focuses on patients in intensive care units who are infected with pathogens such as Acinetobacter baumannii and Pseudomonas aeruginosa. By comparing the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA) dosing strategies, the trial aims to determine the most effective approach to combat these infections. The study is designed to enhance treatment outcomes for patients suffering from severe infections due to antibiotic-resistant bacteria.
Who should consider this trial
Good fit: Ideal candidates for this study are critically ill patients aged 18 and older who are being treated with colistin for multidrug-resistant Gram-negative bacterial infections.
Not a fit: Patients with known hypersensitivity to colistin, pregnant or lactating women, or those with specific neuromuscular conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols for critically ill patients suffering from multidrug-resistant infections.
How similar studies have performed: While the use of colistin has been established, this specific comparison of dosing strategies is novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients age ≥ 18 years old. * Patients who will be treated with CMS for MR GNB infections. * Patients who are admitted to the ICUs. Exclusion Criteria: * Known hypersensitivity to colistin. * Pregnant and lactating women. * Patients who are treated with colistin for \< 24 hours. * Patients with myasthenia gravis or concomitant anesthetics or neuromuscular blocking drugs.
Where this trial is running
Buraidah
- King Fahad Specialist Hospital — Buraidah, Saudi Arabia (Recruiting)
Study contacts
- Principal investigator: Mohamed E Shams, Professor — Mansoura University
- Study coordinator: Abdulmajeed S Alharbi, Master
- Email: majeed4440@hotmail.com
- Phone: 00966503984099
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.