Optimizing Clinical Use of Polymyxin B
Completed
Conditions studied: Pneumonia, Blood Stream Infection, Urinary Tract Infections, Respiratory Tract Infection (Including Tracheobronchitis), Sepsis
In brief
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.
Key facts
- Study ID
- NCT02682355
- Run by
- Rutgers, The State University of New Jersey
- People needed
- 155
- Starts
- 2016-02-01
- Expected to finish
- 2022-08-03
- Last updated by the study team
- 2024-12-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patient of 18 years of age or older
- Expectation of hospitalization and receipt of polymyxin B of ≥ 48 hours
- Receipt of intravenous polymyxin B for treatment of bacteremia and/or urinary tract infection and/or respiratory tract infection (including tracheobronchitis) or sepsis
- Provision of written informed consent by the patient or by the patient's health care proxy if the patient cannot give consent
- Adequate venous access to enable collection of blood for determination of concentrations of polymyxin B and co-administered antibiotics
You may not qualify if…
- Age <18 years
- Currently incarcerated
- Concomitant use of polymyxin B delivered directly into the respiratory tract
- Cystic fibrosis
- Known allergy to CMS/colistin or polymyxin B
- Anticipated death within 48 h of commencing polymyxin B therapy
Where it is running
- 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
- Hospital Sao Lucas da - PUC / RS — Porto Alegre, Brazil
- Hospital Moinhos de Vento — Porto Alegre, Brazil
- Singapore General Hospital — Singapore, Singapore
Full record on ClinicalTrials.gov
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