Diagnostic Accuracy of Pleural Effusion Aspergillosis Biomarker Testing
NCT02104479
Last updated date
ABOUT THIS STUDY
Diagnostic accuracy of biomarker testing (galactomannan (GM), (1
Study Location
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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
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
- Mannheim, Baden-Wuerrtemberg
- 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 |
| |||
| Intervention | Not Provided | |||
| Study Groups/Cohorts |
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| 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 | 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:
Exclusion Criteria:
| |||
| Sex/Gender |
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| 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 |
| |||
| PRS Account | Heidelberg University | |||
| Verification Date | April 2020 | |||