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Study identifier: NCT06843668 Synced from ClinicalTrials.gov · July 29, 2026
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Different Dosing Strategies of Colistin in Multidrug-Resistant Gram-Negative Bacilli Infections

Condition: Critical Ill Patients · Multi Drug Resistant  ·  Sponsor: Mansoura University

PhasePhase 2/Phase 3
Planned participants120
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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…

This description comes directly from the study's public registry record.

Talk to the study team

Abdulmajeed S Alharbi, Master  ·  00966503984099  ·  majeed4440@hotmail.com

Mona M El-Tamalawy, Master  ·  01220650700  ·  mona.m.eltamalawy@gmail.com

Always discuss trial participation with your own doctor first.

Locations (1)

King Fahad Specialist HospitalBuraidah, Saudi ArabiaRecruiting

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Source record: clinicaltrials.gov/study/NCT06843668