Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of Performance of An Aspergillus PCR in Tissue and Pleural Effusion Samples of Immunocompromised Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01902030
Recruitment Status : Enrolling by invitation
First Posted : July 17, 2013
Last Update Posted : April 20, 2020
Sponsor:
Information provided by (Responsible Party):
Dieter Buchheidt, Heidelberg University

Tracking Information
First Submitted Date June 27, 2013
First Posted Date July 17, 2013
Last Update Posted Date April 20, 2020
Study Start Date January 2014
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 15, 2013)
Calculation of sensitivity, Specificity, positive predictive value, negative predictive value and diagnostic odds ratio [ Time Frame: 3 months ]
Evaluation of Sensitivity, Specificity, positive predictive value, negative predictive value and diagnostic odds ratio of aspergillus specific PCR in tissue and effusion samples by comparing the population with proven / probable invasive aspergillosis with patients suffering from No IA according to recent EORTC/MSG criteria of PCR in Biopsies/Effusion samples of Patients
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of Performance of An Aspergillus PCR in Tissue and Pleural Effusion Samples of Immunocompromised Patients
Official Title Diagnostic Study of Performance of an Aspergillus Specific Polymerase Chain Reaction in Tissue and Pleural Effusion Samples of Immunocompromised Patients for the Diagnosis of Invasive Aspergillosis
Brief Summary

Although being a frequent and lethal complication in patients (pts) with hematologic malignancies, diagnosing invasive aspergillosis (IA) still remains a difficult issue as culture-based methods show low sensitivity especially under the current clinical practice of antifungal prophylaxis or rapid antifungal therapy. In certain clinical settings, performing biopsies for identification of the underlying infectious organism becomes important. However, as culture-based methods only yield results in a minority of patients, using non-culture-based methods like Aspergillus specific polymerase chain reaction (PCR) for detection of IA directly in clinical specimens is becoming increasingly important and might help to characterize the causative pathogen.

Therefore the performance of an established Aspergillus-specific nested PCR in biopsies, re-section material or pleural effusions is evaluated.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Fungal DNA, no human DNA
Sampling Method Non-Probability Sample
Study Population
  • Immunocompromised individuals with suspicion of harbouring an invasive fungal infection
Condition
  • Aspergillosis
  • Immunosuppression
Intervention Not Provided
Study Groups/Cohorts
  • Proven/Probable IA Patients
    Case Population
  • possible/No IA Patients
    Control population
Publications *

*   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: July 15, 2013)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Immunocompromised individuals with suspicion of harbouring an invasive fungal infection
  • Definition by 2008 EORTC/MSG Criteria (de Pauw CID 2008)

Exclusion Criteria:

  • none
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 NCT01902030
Other Study ID Numbers ASP PCR IA TISSUE-EFFUSION
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 Not Provided
Investigators
Principal Investigator: Dieter Buchheidt, MD Heidelberg University
PRS Account Heidelberg University
Verification Date April 2020