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Trial record 53 of 180 for:    ERYTHROMYCIN

Risk of QT-prolongation and Torsade de Pointes in Patients Treated With Acute Medication in a University Hospital (RISQ-PATH)

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ClinicalTrials.gov Identifier: NCT02068170
Recruitment Status : Completed
First Posted : February 21, 2014
Last Update Posted : July 28, 2015
Sponsor:
Collaborator:
Agentschap voor Innovatie door Wetenschap en Technologie
Information provided by (Responsible Party):
Eline Vandael, KU Leuven

Brief Summary:

A prospective, observational study in a university hospital (UZ Leuven). Patients are included when they are treated with a potentional QT-prolonging drug: haloperidol for delirium, antibiotics (moxifloxacin, levofloxacin, azithromycin, clarithromycin, erythromycin, co-trimoxazole), antimycotics (ketoconazole, itraconazole, fluconazole, voriconazole), methadone, tacrolimus and oral oncolytics.

An ECG is taken before the administration of the drug and 3-5 days after starting the drug to investigate the change in duration of the QTc-interval. Risk factors for developing QT-prolongation will be documented. Together with ECG2, an additional blood sample will be collected to measure the blood concentration of the drug.


Condition or disease Intervention/treatment
Delirium QT-prolongation Drug: Haloperidol, azi/clari/erythromycin, levo/moxifloxacin, co-trimoxazole, vori/keto/flu/itraconazole, methadone, tacrolimus, sunitinib

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Study Type : Observational
Actual Enrollment : 178 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Risk of QT-prolongation and Torsade de Pointes in Patients Treated With Acute Medication in a University Hospital
Study Start Date : February 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : June 2015


Group/Cohort Intervention/treatment
patients treated with a potentional QT-prolonging drug Drug: Haloperidol, azi/clari/erythromycin, levo/moxifloxacin, co-trimoxazole, vori/keto/flu/itraconazole, methadone, tacrolimus, sunitinib
Other Names:
  • haloperidol: Haldol, ATC-code: N05AD01
  • azithromycin: Zitromax, ATC-code: J01FA10
  • clarithromycin: Biclar, ATC-code: J01FA09
  • erythromycin: Erytroforte, ATC-code: J01FA01
  • levofloxacin: Tavanic, ATC-code: J01MA12
  • moxifloxacin: Avelox, ATC-code: J01MA14
  • co-trimoxazole: Bactrim, Eusaprim, ATC-code: J01EE01
  • voriconazole: Vfend, ATC-code: J02AC03
  • ketoconazole: Nizoral, ATC-code: J02AB02
  • fluconazole: Diflucan, ATC-code: J02AC01
  • itraconazole: Sporanox, ATC-code: J02AC02
  • methadone: ATC-code: N07BC02
  • tacrolimus: Prograft, Advagraft, ATC-code: L04AD02
  • sunitinib: Sutent, ATC-code: L01XE04




Primary Outcome Measures :
  1. change in QTc-interval (corrected for heart rate) [ Time Frame: before and 3-5 days after the start of a potentional QT-prolonging drug ]

Biospecimen Retention:   Samples With DNA
  • 1 blood sample (plasma) to measure the blood concentration of the drug
  • 1 blood sample (DNA) to store in a biobank for additional research


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients treated with acute potentional QT-prolonging medication. In a university hospital.
Criteria

Inclusion Criteria:

  • treatment with a potentional QT-prolonging drug of our list
  • inpatient of UZ Leuven, admitted on one of the participating wards

Exclusion Criteria:

  • < 18 years old
  • DNR-code 3
  • not possible to take an ECG before the start of haloperidol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02068170


Locations
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Belgium
UZ Leuven
Leuven, Belgium, 3000
Sponsors and Collaborators
KU Leuven
Agentschap voor Innovatie door Wetenschap en Technologie
Investigators
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Principal Investigator: Eline Vandael, PhD-student KU Leuven

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Eline Vandael, PhD-student, KU Leuven
ClinicalTrials.gov Identifier: NCT02068170     History of Changes
Other Study ID Numbers: EV003
First Posted: February 21, 2014    Key Record Dates
Last Update Posted: July 28, 2015
Last Verified: July 2015
Keywords provided by Eline Vandael, KU Leuven:
QT-prolongation
Torsade de Pointes
QT-prolonging drugs
Additional relevant MeSH terms:
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Erythromycin
Erythromycin Estolate
Erythromycin Ethylsuccinate
Erythromycin stearate
Delirium
Long QT Syndrome
Torsades de Pointes
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities
Pathologic Processes
Tachycardia, Ventricular
Tachycardia
Moxifloxacin
Trimethoprim, Sulfamethoxazole Drug Combination
Itraconazole
Hydroxyitraconazole
Sunitinib
Methadone