NCT06843668 Different Dosing Strategies of Colistin in Multidrug-Resistant Gram-Negative Bacilli Infections
| NCT ID | NCT06843668 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Mansoura University |
| Condition | Critical Ill Patients |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2023-12-25 |
| Primary Completion | 2025-09-25 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 120 participants in total. It began in 2023-12-25 with a primary completion date of 2025-09-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Nosocomial infections caused by multi-drug-resistant (MDR) and extensively drug-resistant (XDR) Gram-negative pathogens represent a major threat worldwide. The increasing trend of multi-drug resistance in Gram-negative bacteria (MDR-GNB) poses a particularly acute challenge to health systems especially in critically ill patients. Patients in intensive care units (ICUs) have encountered an increasing emergence and spread of antibiotic-resistant pathogens. In Saudi Arabia mainly MDR-GNB such as Acinetobacter Baumannii, Pseudomonas Aeruginosa, Klebsiella Pnemoniae and Enterobacter are observed in ICUs. Polymyxins are the last line therapy in the treatment of infection caused by these MDR-GNB. Colistin is the most widely used polymyxin antibiotic, it is administered as inactive prodrug colistimethate sodium (CMS) that is hydrolyzed to an active moiety of colistin base activity (CBA). It acts as cationic detergent and damages bacterial cytoplasmic membrane causing leaking of intracellular substances and then cell death. During the first years of their use, polymyxin-associated neurotoxicity occurred in patients with an incidence as high as 27% following parenteral administration. However, other retrospective clinical trials have not exposed neurotoxicity to be a major concern. On the other hand, nephrotoxicity is by far the most common and dose-limiting side effect associated with parenteral polymyxins, with incidence rates in patients as high as 60%. Despite the high incidence of colistin induced nephrotoxicity, in 2012, the World Health Organization (WHO) reclassified polymyxins as critically important for the management of MDR-GNB infection, renewing the interest in these antibiotics. To the best of our knowledge no study compared the efficacy and safety of both dosing strategies in critically ill patients. Moreover, there is still a lack of evidence on the efficacy and safety of both dosing strategies in obese patients. Therefore, this study aims at comparing the efficacy and toxicity of both strategies in colistin dosing (the fixed dose and the weight-based dosing) in obese patients and non- obese patients.
Eligibility 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.
Contact & Investigator
Mohamed E Shams, Professor
PRINCIPAL INVESTIGATOR
Mansoura University
Frequently Asked Questions
Who can join the NCT06843668 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Critical Ill Patients. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06843668 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06843668 currently recruiting?
Yes, NCT06843668 is actively recruiting participants. Contact the research team at majeed4440@hotmail.com for enrollment information.
Where is the NCT06843668 trial being conducted?
This trial is being conducted at Buraidah, Saudi Arabia.
Who is sponsoring the NCT06843668 clinical trial?
NCT06843668 is sponsored by Mansoura University. The principal investigator is Mohamed E Shams, Professor at Mansoura University. The trial plans to enroll 120 participants.