To investigate the correlation of pharmacokinetic parameters of anidulafungin with markers for disease severity and plasma protein levels.
ID
Source
Brief title
Condition
- Fungal infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the correlation between pharmacokinetic parameters and
disease severity scores or a single clinical parameter. Pharmacokinetic
parameters will be calculated out of anidulafungin levels and relevant patient
data (i.e. bodyweight, renal function, etc) using KINFIT (MWPharm 3.60;
Mediware, The Netherlands). A Spearman correlation coefficient will be
calculated to assess correlation as we expect that the results will be not
normally distributed.
Secondary outcome
1) Time (in days) to culture conversion
2) Response to treatment at day 28
3) Mortality at day 28 due to fungal infection and overall mortality at 28 days
4) AUC/MIC ratio, time above MIC
5) Composing a pharmacokinetic model of anidulafungin in critically ill
patients.
Background summary
Patients in the ICU are more at risk for the development of invasive
candidiasis than patients on other wards. Attributable mortality of candidiasis
was evaluated retrospectively between 2003 and 2007 in a hospital in the UK.
The crude mortality among ICU case patients was 45.0% compared with 16.7% in
the matched controls; the resulting **attributable mortality** was therefore
estimated to be 28.3%.
One of the risk factors for mortality of patients with candidemia is inadequate
therapy. So it is important to start antifungal therapy as soon as possible and
ensure that adequate levels are reached.
At this moment there are several clues that the pharmacokinetics of
anidulafungin in critically ill patients is different, but an overall picture
is lacking.
Study objective
To investigate the correlation of pharmacokinetic parameters of anidulafungin
with markers for disease severity and plasma protein levels.
Study design
This study is an observational pharmacokinetic study. At day 3 (± 1 day) after
start of treatment a full anidulafungin concentration-time curve will be
obtained. Blood samples are taken just before administering anidulafungin and
at 1.5, 2, 3, 4, 6, 8, 12 and 24 hour after the start of the infusion. Besides,
trough levels will be followed longitudinally during treatment with a maximum
of 28 days every three days to evaluate potential fluctuations in levels over
time.
Study burden and risks
There is no direct benefit for the subjects in this study. Result of this study
may however contribute to tailor-made dosing for future patients, but
conceivably also for the patients studied for future episodes of illness with
suspected invasive fungal infection.
The extra blood samples needed to study the pharmacokinetics are no extra
burden as these patients already have an indwelling catheter.
This study can not be conducted without these patients as these are subject of
investigation.
Hanzeplein 1
9713 GZ Groningen
NL
Hanzeplein 1
9713 GZ Groningen
NL
Listed location countries
Age
Inclusion criteria
treatment with anidulafungin
at least 18 years of age
invasive canidiasis
admitted to an intensive care unit
Exclusion criteria
allergic to anidulafungin or its excipients
contra-indication stated in IB1-brochure
neutropenia
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2009-016386-28-NL |
| CCMO | NL30035.042.09 |