Vancomycin Associated Red Man Syndrome (RMS)

Completed

Conditions studied: Red Man Syndrome

In brief

This study proposes to identify patients who developed RMS with vancomycin infusion, and determine presence or absence of variant alleles involved in histamine biotransformation. The implications of this study are important, as identification of variant alleles in these patients, may alter the current standard of care for vancomycin infusions. The hypothesis of this study is that the development of red man syndrome (RMS) during receipt of intravenous vancomycin is associated with the presence of variant alleles for genes involved in the histamine pathway. The primary outcome that will be measured will be the history of RMS and the presence or absence of variant alleles for the genes responsible for histamine metabolism (i.e. histamine n-methyltransferase and diamine oxidase). As a secondary endpoint, the study will also attempt to determine the incidence of RMS in pediatric patients.

Key facts

Study ID

NCT00824122

Run by

Children's Mercy Hospital Kansas City

People needed

544

Starts

2008-01-01

Expected to finish

2011-10-01

Last updated by the study team

2011-10-12

Who can join

Age: 1 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have received vancomycin

You may not qualify if…

• Patients who have received antihistamines at the time of vancomycin administration or
• Patients who have been on steroids or tricyclic antidepressants within 30 days prior to the vancomycin administration
• People receiving ECMO or have multiorgan failure
• Currently receiving dialysis

Where it is running

• Children's Mercy Hospital & Clinics — Kansas City, Missouri, United States

Full record on ClinicalTrials.gov

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