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Clinical trialNCT02682355CompletedObservational

Optimizing Clinical Use of Polymyxin B

SponsorRutgers, The State University of New JerseyEnrollment155Blood Stream InfectionPneumoniaRespiratory Tract Infection (Including Tracheobronchitis)SepsisUrinary Tract Infections
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

6 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Brazil
  • Hospital Moinhos de Vento

    Porto Alegre, Brazil

  • Hospital Sao Lucas Da - Puc / Rs

    Porto Alegre, Brazil

Singapore
  • Singapore General Hospital

    Singapore, Singapore

United States
  • Northwestern University

    Chicago, Illinois, United States

  • Columbia University Medical Center

    New York, New York, United States

  • New York Presbyterian-Weill Cornell Medical Center

    New York, New York, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
29 Feb 2016
Primary completion
31 May 2022
Completion
3 Aug 2022
Last update posted
2 Dec 2024
Registered enrollment
155
Registry id
NCT02682355
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.