Optimizing Clinical Use of Polymyxin B
Launched by RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY · Feb 10, 2016
Trial Information
Current as of June 12, 2025
Completed
Keywords
ClinConnect Summary
Multidrug-resistant (MDR) Gram-negative 'superbugs' are rapidly spreading around the world, and polymyxin B and colistin (polymyxin E) are often the only effective antibiotics. Since polymyxin B was released in the 1950s, its pharmacokinetics, pharmacodynamics, toxicodynamics (PK/PD/TD) have never been defined. Recent pharmacological research on polymyxins has predominantly focused on colistin methanesulfonate (CMS, an inactive prodrug of colistin) and demonstrates that CMS has significant limitations. Thus, polymyxin B is increasingly being viewed as the preferred polymyxin. Unfortunately,...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Patient of 18 years of age or older
- • 2. Expectation of hospitalization and receipt of polymyxin B of ≥ 48 hours
- • 3. Receipt of intravenous polymyxin B for treatment of bacteremia and/or urinary tract infection and/or respiratory tract infection (including tracheobronchitis) or sepsis
- • 4. Provision of written informed consent by the patient or by the patient's health care proxy if the patient cannot give consent
- • 5. Adequate venous access to enable collection of blood for determination of concentrations of polymyxin B and co-administered antibiotics
- Exclusion Criteria:
- • 1. Age \<18 years
- • 2. Currently incarcerated
- • 3. Concomitant use of polymyxin B delivered directly into the respiratory tract
- • 4. Cystic fibrosis
- • 5. Known allergy to CMS/colistin or polymyxin B
- • 6. Anticipated death within 48 h of commencing polymyxin B therapy
About Rutgers, The State University Of New Jersey
Rutgers, The State University of New Jersey, is a prestigious public research university renowned for its commitment to advancing medical science and public health. As a leading clinical trial sponsor, Rutgers leverages its extensive academic resources, cutting-edge facilities, and a diverse team of experts to conduct innovative research that addresses critical health challenges. The university fosters collaboration across disciplines, engaging in partnerships with healthcare institutions and industry leaders to enhance the development of novel therapies and improve patient outcomes. With a strong emphasis on ethical standards and regulatory compliance, Rutgers is dedicated to advancing clinical knowledge while prioritizing participant safety and well-being in all of its research endeavors.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chicago, Illinois, United States
New York, New York, United States
Columbus, Ohio, United States
Porto Alegre, , Brazil
New York, New York, United States
Porto Alegre, , Brazil
Singapore, , Singapore
Patients applied
Trial Officials
Keith S Kaye, MD, MPH
Principal Investigator
Rutgers University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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