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Optimizing Clinical Use of Polymyxin B

NCT02682355 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 155

Last updated 2024-12-02

No results posted yet for this study

Summary

Polymyxin B is already being used extensively in the USA and other parts of the world; its use is likely to rapidly increase due to the greater burden of infections caused by MDR Gram-negative bacteria and the growing awareness of the limitations inherent in the clinical pharmacology of CMS/colistin. Cross resistance exists between the two polymyxins and thus both must be dosed optimally; but the recently generated scientifically-based dosage regimens for CMS/colistin cannot be extrapolated to polymyxin B. It is essential that an adequately powered study is conducted to define the clinical PK/PD/TD relationships of polymyxin B and identify, using next-generation proteomics, biomarkers for early detection of kidney injury. This will allow the development of scientifically-based dosage regimens for various categories of patients and an adaptive feedback control clinical tool for optimized dosing of polymyxin B in future individual patients.

Conditions

Sponsors & Collaborators

  • Rutgers, The State University of New Jersey

    lead OTHER

Principal Investigators

  • Keith S Kaye, MD, MPH · Rutgers University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2022-05-31
Completion
2022-08-03

Countries

  • United States
  • Brazil
  • Singapore

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02682355 on ClinicalTrials.gov