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Search / Trial NCT02682355

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.

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

0 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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