Antibiotic bloodlevels in elderly.|
|- candidate number||5464|
|- NTR Number||NTR1725|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||16-mrt-2009|
|- Secondary IDs||08-4-063 MEC Maastricht|
|- Public Title||Antibiotic bloodlevels in elderly.|
|- Scientific Title||Antibiotic bloodlevels in elderly.|
|- hypothesis||Pharmacokinetics and pharmacodynamics are different between elderly and younger persons, because of physiologic changes due to ageing and chronic diseases, which could have an influence on antibiotic bloodlevels. |
|- Healt Condition(s) or Problem(s) studied||Older adults|
|- Inclusion criteria||Patients older than 18 years receiving IV amoxicillin, flucloxacillin, ciprofloxacin, gentamycin and or vancomycin. Patients should have enough data available, such as the exact time of antibiotic administration, dosages, diagnosis, weight, age and co-medication.
|- Exclusion criteria||Patients younger than 18 years.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-apr-2009|
|- planned closingdate||31-mrt-2011|
|- Target number of participants||1000|
|- Interventions||During the treatment of a patient with iv antibiotics, blood from the clinical chemistry laboratory and the laboratory of the pharmacy will be used to determine the antibiotic blood levels. The blood samples will be frozen within 24 hours. At a later stage the antibiotic blood levels will be determined. Amoxicillin, flucloxacillin and ciprofloxacin will be measured with HPLC-UV methods. Gentamycin and vancomycin will be done routinely with the COBAS Integra 700 analyzer. Four age groups, 18-44 years, 45-64 years, 65-79 years and older than 80 years will be compared. Pharmacokinetic calculations will be done with MW\PHARM 3.6 (mediware, Groningen). The principle is a posteriori Bayesian fitting for individual patients and an iterative Bayesian fitting for the calculation of population parameters. Statistical calculations will be done with SPSS 16.0.
|- Primary outcome||Blood levels for amoxicillin, flucloxacillin, ciprofloxacin, gentamycin and vancomycin in elderly.
|- Secondary outcome||Side effects .|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| M.B. Haeseker|
|- CONTACT for SCIENTIFIC QUERIES|| M.B. Haeseker|
|- Sponsor/Initiator ||CAPHRI, The Research Institute of the University Maastricht and University Hospital Maastricht (AZM)|
(Source(s) of Monetary or Material Support)
|University Hospital Maastricht (AZM), CAPHRI, The Research Institute of the University Maastricht |
|- Brief summary||Background:|
Infectious diseases are more common in elderly and associated with poor outcome. Common infections seen in elderly are:
1. Respiratory tract infections;
2. Urinary tract infections;
3. Infections of skin and soft tissue.
There are changes in pharmacokinetics and pharmacodynamics between elderly and younger persons, because of physiologic changes due to ageing and chronic diseases, which could influence antibiotic blood levels. E.g. changes in body composition change the distribution, binding proteins are decreased and the glomerular filtration rate (GFR), tubular secretion and renal blood flow are decreased with age. It is expected that antibiotic blood levels differ in elderly.
1. To investigate whether antibiotic blood levels and pharmacokinetic parameters differ in an elderly population and possible influencing co-variables;
2. To investigate whether side effects are more common in elderly in relationship with co-morbidity, co-medication and antibiotic blood levels.
In all patients older than 18 years that receive intravenous antibiotics, the antibiotic blood levels will be measured. Five antibiotics will be measured. Amoxicillin, flucloxacillin and ciprofloxacin will be measured with HPLC-UV (high performance liquid chromatography) methods, gentamycin and vancomycin will be measured with the COBAS INTEGRA 700 analyser. Other data, like Hb, leucocytes, CRP, renal function and liver function will be retrieved from Mirador (an electronic medical file system).
Pharmacokinetic calculations will be done with MW/PHARM 3.6 (Mediware, Groningen). Statistical calculations, like multiple regression analysis, will be done with SPSS 16.0.
1. Yoshikawa TT. Epidemiology and Unique Aspects of Aging and Infectious Diseases. Clin Infect Dis 2000 30:931-33;
2. Trends in pneumonia and influenza morbidity and mortality. New York, American Lung association, Research and Scientific affairs, Epidemiology and Statistics Unit. 2004. (+1995);
3. Feldman C. Pneumonia in the Elderly. Med Clin North Am 2001 Nov; 85 (6): 1441-59;
4. Richards CL. Urinary tract infections in the frail elderly: Issues for diagnosis, treatment and prevention. Int Urol Nephrol 36 (3) 2004 pp 457-63;
5. S. Laube. Skin Infections and Ageing. Ageing Res Rev 3 2004 pp.69-89;
6. Herring AR. Principle of antimicrobial use in older adults. Clin Geriatr 2007; 23: 481-497.
|- Main changes (audit trail)|
|- RECORD||16-mrt-2009 - 14-sep-2009|
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