Diagnostic Accuracy of Pleural Effusion Aspergillosis Biomarker Testing

NCT02104479

Last updated date
Study Location
University Hospital Mannheim
Mannheim, Baden-Wuerrtemberg, 68167, Germany
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Invasive Aspergillosis, Pleural Effusion, Immunosuppression
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Age < 18 years


- missing informed consent


- contraindication for pleural centesis

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Invasive Aspergillosis, Pleural Effusion, ImmunosuppressionDiagnostic Accuracy of Pleural Effusion Aspergillosis Biomarker Testing
NCT02104479
  1. Mannheim, Baden-Wuerrtemberg
  2. Wuerzburg, Bayern
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Diagnostic Accuracy of Pleural Effusion Aspergillosis Biomarker Testing
Official Title Open Multicenter Diagnostic Study on the Accuracy of Biomarker Testing (Galactomannan (GM), (1-3)-?-D-glucan (BDG), Aspergillus-specific Polymerase Chain Reaction (PCR) Assay) in Pleural Effusion Samples of Immunocompromised Patients With Suspected Invasive Pulmonary Aspergillosis (IPA)
Brief Summary Diagnostic accuracy of biomarker testing (galactomannan (GM), (1
Detailed Description A multicentre, open, prospective diagnostic study on the diagnostic accuracy of biomarker testing (galactomannan (GM), (1
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
only fungal DNA is investigated, no human DNA
Sampling Method Probability Sample
Study Population - Immunocompomised Patients based on the following conditions: 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,
Condition
  • Invasive Aspergillosis
  • Pleural Effusion
  • Immunosuppression
Intervention Not Provided
Study Groups/Cohorts
  • Immunocompromised Patients
    Immunocompromised patients with suspected IPA who have Pleural effusions act as the observed study population
  • Control Group
    Patients without Immunosuppression with pleural effusions
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: April 1, 2014)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT02104479
Other Study ID Numbers EFFU-ASP 2014
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dieter Buchheidt, Heidelberg University
Study Sponsor Heidelberg University
Collaborators Pfizer
Investigators
Principal Investigator:Dieter Buchheidt, MDUniversitätsmedizin Mannheim
PRS Account Heidelberg University
Verification Date April 2020