Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01866020 |
| Other study ID # |
DipA |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
May 27, 2013 |
| Last updated |
May 28, 2015 |
| Start date |
January 2013 |
| Est. completion date |
January 2015 |
Study information
| Verified date |
May 2015 |
| Source |
Universitätsklinikum Hamburg-Eppendorf |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Germany: Federal Institute for Drugs and Medical Devices |
| Study type |
Observational
|
Clinical Trial Summary
Invasive pulmonary aspergillosis (IPA) is difficult to diagnose and remains a cause of high
morbidity and mortality in critically ill patients in the ICU. Accepted diagnostic protocols
for haemato-oncological patients are not applicable for critically ill patients in ICUs.
Definitive discrimination between aspergillic colonisation and IPA often depends on the
clinical experience of the treating physician, evaluating clinical signs, co-morbidities,
and course of the disease. Life saving treatment with the first line antimycotic Voriconazol
(Vfend®) can only be initiated after diagnosis of IPA.
In this prospective clinical trial the investigators aim to structure, optimize and fast
track the diagnostic pathway of IPA in critically ill patients treated in our
ICU-department.
Description:
Invasive pulmonary aspergillosis (IPA) is difficult to diagnose and remains a cause of high
morbidity and mortality in critically ill patients in the ICU. The number of patients with
positive Aspergillus culture or galactomannan test in respiratory fluids is increasing every
year. In 2007 our Department tested 21 patients positive for Aspergillus, in 2009 it were 49
and last year (2011) the investigators found 59 patients to be positive in our 10
multidisciplinary ICUs. Accepted diagnostic protocols for haemato-oncological patients are
not applicable for critically ill patients in ICUs. Halo signs, a typical radiological
indication for IPA, can be found in haematological patients, but in patients in the ICU
these signs are likely to be masked by pneumonic infiltrations due to ventilator induced
lung injury and pneumonia. Microbiological diagnostics, like quantification of galactomannan
in bronchoalveolar lavage specimens, change upon antibiotic treatment. It can be false
positive in patients treated with beta-lactam antibiotics. Definitive discrimination between
aspergillic colonisation and IPA often depends on the clinical experience of the treating
physician, evaluating clinical signs, co-morbidities, and course of the disease. Life saving
treatment with the first line antimycotic Voriconazol (Vfend®) can only be initiated after
diagnosis of IPA.
In this prospective clinical trial the investigators aim to structure, optimize and fast
track the diagnostic pathway of IPA in critically ill patients treated in our
ICU-department. After successful diagnosis, primary endpoints of this study will be 28-day
mortality and duration of the ICU stay. Secondary endpoints will include differences in
antimycotic treatments, ventilation time and type of ventilation, co - morbidities and
treatment costs between patients in the colonisation and IPA group.
Adult patients treated in one of our ten multidisciplinary ICUs with either positive
respiratory fluid cultures for Aspergillus species or positive galactomannan test will be
prospectively enrolled. During the 18 month enrollment period (January 2013 until July 2014)
the investigators plan to screen all critically ill patients and enroll a minimum of 60
patients, which represents the expected number of patients diagnosed with an IPA in the
proposed time frame. In agreement with our standard operating procedure, all study patients
will be routinely subjected to the following examinations, tests and receive diagnostic
interventions, but the investigator does not assign specific interventions to the patients
of the study. A bronchoalveolar lavage, will be performed by a senior pulmonologist, to
identify typical Aspergillus plaques and to obtain sufficient material for microbiological
analysis (galactomannan test + polymerase chain reaction (PCR)). Blood samples for a
galactomannan test will be drawn additionally. The galactomannan tests will be repeated
weekly as long as the infection symptoms persist. Furthermore, patients will be subjected to
high-resolution computer tomography of the thorax. Clinical and diagnostic data from all
patients will be collected in a centralized database for subsequent analysis in this study.
