NCT01247142

Brief Summary

The purpose of this study is to evaluate the diagnostic potential of biomarkers for invasive pulmonary aspergillosis in exhaled breath condensate.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 24, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

July 8, 2014

Status Verified

July 1, 2014

Enrollment Period

3.5 years

First QC Date

November 23, 2010

Last Update Submit

July 4, 2014

Conditions

Invasive Pulmonary Aspergillosis

Keywords

invasive pulmonary aspergillosisexhaled breath condensate

Outcome Measures

Primary Outcomes (1)

  • The identification of biomarkers for invasive pulmonary aspergillosis (IPA) in exhaled breath condensate (EBC)

    15 months

Study Arms (2)

Invasive pulmonary aspergillosis (IPA)

Patients with proven or probable invasive pulmonary aspergillosis (IPA) (EORTC/MSG criteria) or putative IPA (Blot et al. Am J Respir Crit Care Med 2012)

Controls

Patients without signs of infection.

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Hospitalized adult patients of the department of Hematology or Intensive Care Unit, University Hospital, Leuven, Belgium

You may qualify if:

  • hospitalisation in the hematology or intensive care department
  • age \> 16 years
  • informed consent
  • proven or probable IPA (EORTC/ MSG criteria)
  • galactomannan positivity in BAL or serum

You may not qualify if:

  • age \< 16 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

exhaled breath condensate

MeSH Terms

Conditions

Invasive Pulmonary Aspergillosis

Condition Hierarchy (Ancestors)

Pulmonary AspergillosisAspergillosisMycosesBacterial Infections and MycosesInfectionsInvasive Fungal InfectionsLung Diseases, FungalLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD fellow

Study Record Dates

First Submitted

November 23, 2010

First Posted

November 24, 2010

Study Start

January 1, 2011

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

July 8, 2014

Record last verified: 2014-07

Locations

BE(1)