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The effect of monitoring of tobramycin levels in blood in patients with cystic fibrosis.


- candidate number17597
- NTR NumberNTR4544
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-mei-2014
- Secondary IDsE.M. Kemper
- Public TitleThe effect of monitoring of tobramycin levels in blood in patients with cystic fibrosis.
- Scientific TitleThe effect of Therapeutic Drug Monitoring of tobramycin in patients with cystic fibrosis.
- ACRONYM
- hypothesisTherapeutic drug monitoring is effective in optimizing treatment with tobramycin and reduces side effects.
- Healt Condition(s) or Problem(s) studiedCystic Fibrosis (CF), Therapeutic drug monitoring
- Inclusion criteria- Patients with cystic fibroses. - Treatment with tobramycin - Plasma concentration of tobramycine routinely measured
- Exclusion criteriaNone
- mec approval receivedno
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-mei-2014
- planned closingdate1-aug-2014
- Target number of participants35
- InterventionsNo interventions: retrospective, observational study
- Primary outcomePlasma tobramycine levels within the target range
- Secondary outcomeInfluence of different parameter like e.g. weight, kidney function, male/female on the dosage.
- TimepointsTobramycine levels of 2011, 2012 and 2013 will be retrospectively analysed in 2014
- Trial web site-
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDr. E.M. Kemper
- CONTACT for SCIENTIFIC QUERIESDr. E.M. Kemper
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- Publications-
- Brief summaryPatients with cystic fibroses often receive the antibiotic tobramycin during a long period to treat Pseudomonas aeruginosa infection. During standard care tobramycin levels in blood are determined to give an indication of safety and efficacy. When the tobramycin levels are outside a certain range, the dosage will be adjusted. In this study we will retrospectively determine if adjustment of the dosage was effective and if there are certain factors influencing the dosage (e.g. body weight).
- Main changes (audit trail)
- RECORD4-mei-2014 - 21-mei-2014


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