Focus: Immunocompromised Individuals at High Risk of Aqcuiring Invasive AspergillosisNCT01614145
Diagnostic Performance of an Aspergillus-specific Nested PCR Assay in Cerebrospinal Fluid Samples
An observational study of Focus: Immunocompromised Individuals at High Risk of Aqcuiring Invasive Aspergillosis, run by Heidelberg University at 3 sites in Germany.
Trial summary
Multicentre, diagnostic study evaluating the performance of an aspergillus-specific PCR in cerebrospinal fluid samples of immunocompromised patients for identification of central nervous system aspergillosis. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Focus: Immunocompromised Individuals at High Risk of Aqcuiring Invasive Aspergillosis
- How many people
- 200 participants
- Where
- 3 sitesGermany
- Study dates
- Sep 2007to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Immunocompromised patients at risk for invasive aspergillosis
Who may be able to join
- Host factors
- Informed consent
Who cannot join
- none
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Frankfurt (Oder) General Hospital
Frankfurt (Oder), Brandenburg, 15236
Freiburg University Hospital
Freiburg im Breisgau, Baden-Würrtemberg, 79106
Mannheim University Hospital
Mannheim, Baden-Würrtemberg, 68167
About this study
Official title: Diagnostic Study Evaluating the Performance of an Aspergillus-specific Nested PCR Assay in Cerebrospinal Fluid Samples of Immunocompromised Patients for Detection of Central Nervous System Aspergillosis
Multicentre, diagnostic study evaluating the performance of an aspergillus-specific PCR in cerebrospinal fluid samples of immunocompromised patients for identification of central nervous system aspergillosis.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Proven/probable CNS IA | Immunocompromised patients with proven/probable invasive CNS Aspergillosis based on modified criteria by the EORTC/MSG | |
| Possible/No CNS IA | Immunocompromised patients with possible/NoIA invasive CNS Aspergillosis based on modified criteria by the EORTC/MSG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test sensitivity
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2012 (estimated)
- Study startSep 2007
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focus: Immunocompromised Individuals at High Risk of Aqcuiring Invasive AspergillosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dieter Buchheidt, Heidelberg University
- Investigators
- Dieter Buchheidt, MD, Principal investigator, Germany: Mannheim University Hospital, University of Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01614145
- Sponsor's protocol ID
- CSF Aspergillus PCR
- Status last verified
- Apr 2020
- First submitted
- 5 Jun 2012
- Last updated
- 20 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Study Evaluating the Performance of an Aspergillus-specific Nested PCR Assay in Cerebrospinal Fluid Samples of Immunocompromised Patients for Detection of Central Nervous System Aspergillosis
- ClinicalTrials.gov ID
- NCT01614145
- Acronym / sponsor ID
- CSF Aspergillus PCR
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 7 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multicentre, diagnostic study evaluating the performance of an aspergillus-specific PCR in cerebrospinal fluid samples of immunocompromised patients for identification of central nervous system aspergillosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proven/probable CNS IA | – | –Immunocompromised patients with proven/probable invasive CNS Aspergillosis based on modified criteria by the EORTC/MSG |
| Possible/No CNS IA | – | –Immunocompromised patients with possible/NoIA invasive CNS Aspergillosis based on modified criteria by the EORTC/MSG |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Immunocompromised patients at risk for invasive aspergillosis
Key inclusion criteria (2 listed)
- Host factors
- Informed consent
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Test sensitivity
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dieter Buchheidt, MD principal investigator
Germany: Mannheim University Hospital, University of Heidelberg
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Focus: Immunocompromised Individuals at High Risk of Aqcuiring Invasive Aspergillosis, run by Heidelberg University at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test sensitivity (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2020.