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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT02104479
Other study ID # EFFU-ASP 2014
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date March 31, 2014
Est. completion date December 31, 2020

Study information

Verified date April 2020
Source Heidelberg University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Diagnostic accuracy of biomarker testing (galactomannan (GM), (1


Description:

A multicentre, open, prospective diagnostic study on the diagnostic accuracy of biomarker testing (galactomannan (GM), (1


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 200
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- prolonged neutropenia > 10 d, patients

- after allogeneic stem cell transplantation or solid organ transplantation,

- Patients wth acute leukemia in induction treatment,

- patients witrh graft-versus-host-disease,

- patients under chronic immunusuppressive therapy such as ciclosporin,

- patients with HIV,

- patients with chronic steroid treatment

Exclusion Criteria:

- Age < 18 years

- missing informed consent

- contraindication for pleural centesis

Study Design


Locations

Country Name City State
Germany University Hospital Mannheim Mannheim Baden-Wuerrtemberg
Germany Wuerzburg University Hospital Wuerzburg Bayern

Sponsors (2)

Lead Sponsor Collaborator
Heidelberg University Pfizer

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Reinwald M, Spiess B, Heinz WJ, Heussel CP, Bertz H, Cornely OA, Hahn J, Lehrnbecher T, Kiehl M, Laws HJ, Wolf HH, Schwerdtfeger R, Schultheis B, Burchardt A, Klein M, Dürken M, Claus B, Schlegel F, Hummel M, Hofmann WK, Buchheidt D. Aspergillus PCR-based investigation of fresh tissue and effusion samples in patients with suspected invasive Aspergillosis enhances diagnostic capabilities. J Clin Microbiol. 2013 Dec;51(12):4178-85. doi: 10.1128/JCM.02387-13. Epub 2013 Oct 9. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Test Sensitivity one year
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