Diagnosis of Invasive Pulmonary Aspergillosis (IPA) in Critically Ill Patients (DipA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Universitätsklinikum Hamburg-Eppendorf
Sponsor:
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT01866020
First received: May 27, 2013
Last updated: June 2, 2013
Last verified: June 2013
  Purpose

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.


Condition
Survival After IPA
Risk Factors for IPA

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Diagnosis of Invasive Pulmonary Aspergillosis (IPA) in Critically Ill Patients - a Prospective Clinical Trial in the Department of Intensive Care, University Medical Center Hamburg-Eppendorf (UKE)

Resource links provided by NLM:


Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

Primary Outcome Measures:
  • death after 6 month [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    we follow the patients after 6 month


Secondary Outcome Measures:
  • death after 28 days [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    we follow the patients for 28 days


Estimated Enrollment: 60
Study Start Date: January 2013
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

adult patients

Criteria

Inclusion Criteria:

  • > 18 years
  • positive aspergillus culture in respiratory tract sample OR
  • positive aspergillus galactomannan in respiratory tract sample

Exclusion Criteria:

  • no inform consent
  • age < 18 years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01866020

Contacts
Contact: Maria Metschke, MD 00494074107010 m.metschke@uke.de

Locations
Germany
University Medical Center Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Maria Metschke, MD       m.metschke@uke.de   
Principal Investigator: Maria Metschke, MD         
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Investigators
Principal Investigator: Maria Metschke, MD Universitätsklinikum Hamburg-Eppendorf
  More Information

No publications provided

Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT01866020     History of Changes
Other Study ID Numbers: DipA
Study First Received: May 27, 2013
Last Updated: June 2, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
aspergillosis
fungal infection
ICU

Additional relevant MeSH terms:
Aspergillosis
Pulmonary Aspergillosis
Invasive Pulmonary Aspergillosis
Critical Illness
Disease Attributes
Pathologic Processes
Hyalohyphomycosis
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Skin Diseases
Lung Diseases, Fungal
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 16, 2014