NCT01430663

Brief Summary

Diagnosing invasive pulmonary aspergillosis (IPA) remains a challenge in patients (pts) with hematological malignancies. The clinical significance of testing bronchoalveolar lavage (BAL) samples both with polymerase chain reaction (PCR) and Aspergillus galactomannan (GM) ELISA is unclear, and the BAL cutoff for GM has not been clearly defined yet. Using a validated nested PCR assay and a GM ELISA, we prospectively examine BAL samples from hematological patients at high risk of PA.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
87

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2007

Longer than P75 for all trials

Geographic Reach
2 countries

9 active sites

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

Study Start

First participant enrolled

April 1, 2007

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2011

Completed
Last Updated

April 20, 2020

Status Verified

April 1, 2020

Enrollment Period

3.8 years

First QC Date

September 6, 2011

Last Update Submit

April 17, 2020

Conditions

Invasive Aspergillosis

Keywords

aspergillosisbronchoalveolar lavagegalactomannanpcrhematological patients

Outcome Measures

Primary Outcomes (1)

  • Clinical significance of biomarker based diagnostic investigation in suspected invasive aspergillosis

    up to 18 months

Secondary Outcomes (1)

  • Evaluation of diagnostic and therapeutic intervention concerning antifungal treatment with regard to outcome (overall survival, in months) of a fungal infection

    up to 18 months

Study Arms (2)

Hematological patients with proven or probable aspergillosis

Hematological patients with possible aspergillosis

Eligibility Criteria

Age5 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

hematological patients at high risk for invasive aspergillosis

You may qualify if:

  • \- hematological patients with lung infiltrates at high risk for invasive aspergillosis

You may not qualify if:

  • \- patients without informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Innsbruck University Hospital

Innsbruck, Austria

Location

Cologne University Hospital

Cologne, Germany

Location

Erlangen University Hospital

Erlangen, Germany

Location

General Hospital Frankfurt (Oder)

Frankfurt (Oder), Germany

Location

Freiburg University Hospital

Freiburg im Breisgau, Germany

Location

Halle University Hospital

Halle, Germany

Location

Herne University Hospital

Herne, Germany

Location

Mannheim University Hospital

Mannheim, 68167, Germany

Location

Würzburg University Hospital

Würzburg, Germany

Location

Related Publications (4)

  • Skladny H, Buchheidt D, Baust C, Krieg-Schneider F, Seifarth W, Leib-Mosch C, Hehlmann R. Specific detection of Aspergillus species in blood and bronchoalveolar lavage samples of immunocompromised patients by two-step PCR. J Clin Microbiol. 1999 Dec;37(12):3865-71. doi: 10.1128/JCM.37.12.3865-3871.1999.

    PMID: 10565898BACKGROUND

  • Buchheidt D, Baust C, Skladny H, Ritter J, Suedhoff T, Baldus M, Seifarth W, Leib-Moesch C, Hehlmann R. Detection of Aspergillus species in blood and bronchoalveolar lavage samples from immunocompromised patients by means of 2-step polymerase chain reaction: clinical results. Clin Infect Dis. 2001 Aug 15;33(4):428-35. doi: 10.1086/321887. Epub 2001 Jul 6.

    PMID: 11462176BACKGROUND

  • Spiess B, Buchheidt D, Baust C, Skladny H, Seifarth W, Zeilfelder U, Leib-Mosch C, Morz H, Hehlmann R. Development of a LightCycler PCR assay for detection and quantification of Aspergillus fumigatus DNA in clinical samples from neutropenic patients. J Clin Microbiol. 2003 May;41(5):1811-8. doi: 10.1128/JCM.41.5.1811-1818.2003.

    PMID: 12734210BACKGROUND

  • Hummel M, Spiess B, Cornely OA, Dittmer M, Morz H, Buchheidt D. Aspergillus PCR testing: results from a prospective PCR study within the AmBiLoad trial. Eur J Haematol. 2010 Aug;85(2):164-9. doi: 10.1111/j.1600-0609.2010.01452.x. Epub 2010 Apr 1.

    PMID: 20374275BACKGROUND

MeSH Terms

Conditions

AspergillosisPathologic Complete Response

Condition Hierarchy (Ancestors)

MycosesBacterial Infections and MycosesInfectionsDisease ProgressionDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Dieter Buchheidt, MD

    Mannheim University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

September 6, 2011

First Posted

September 8, 2011

Study Start

April 1, 2007

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

April 20, 2020

Record last verified: 2020-04

Locations

AU(1)DE(8)