AspergillosisNCT00473252
Surveillance of Fungal Infections During Construction Activity
An observational study of Aspergillosis, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Fungal infections in immunocompromised patients occuring during construction activities in hospitals have repeatedly been reported. However, the question of a causal relation between construction activities and infections has never been addressed systematically and prospectively. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Aspergillosis
- How many people
- 340 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2006to Jul 2009
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Prevalent hemodialysis patients and incident renal transplant recipients in the Department of Nephrology and Hypertension, University Hospital Bern, Switzerland
Who may be able to join
- Kidney transplantation
- Chronic hemodialysis treatment
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Dept. Nephrology & Hypertension, Univ. Hospital Bern
Bern, Canton of Bern, 3010
About this study
Fungal infections in immunocompromised patients occuring during construction activities in hospitals have repeatedly been reported.
However, the question of a causal relation between construction activities and infections has never been addressed systematically and prospectively.
To answer this question, we will monitor our immunosuppressed patients' health status, as well as fine dust and aspergillus spore contents in the air during a three year construction activity period in our hospital.
- Conditions
- Aspergillosis
- Keywords
- aspergillus infections, immunosuppression, kidney transplantation, hemodialysis, galactomannan test, fine dust, construction activity, airborne aspergillus spores
- Medical subject headings
- 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 |
|---|---|---|
| Hemodialysis patients | Not described | |
| Renal transplant patients | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2007 (estimated)
- Study startMay 2006
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AspergillosisStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Investigators
- Andreas Pasch, MD, Study director, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00473252
- Sponsor's protocol ID
- BE003
- Status last verified
- May 2011
- First submitted
- 14 May 2007
- Last updated
- 20 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surveillance of Fungal Infections During Construction Activity
- ClinicalTrials.gov ID
- NCT00473252
- Acronym / sponsor ID
- BE003
- Conditions
- Aspergillosis
- Keywords
- aspergillus infections, immunosuppression, kidney transplantation, hemodialysis, galactomannan test, fine dust, construction activity, airborne aspergillus spores
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 15 May 2007 (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.
Fungal infections in immunocompromised patients occuring during construction activities in hospitals have repeatedly been reported.
However, the question of a causal relation between construction activities and infections has never been addressed systematically and prospectively.
To answer this question, we will monitor our immunosuppressed patients' health status, as well as fine dust and aspergillus spore contents in the air during a three year construction activity period in our hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemodialysis patients | – | – |
| Renal transplant patients | – | – |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Prevalent hemodialysis patients and incident renal transplant recipients in the Department of Nephrology and Hypertension, University Hospital Bern, Switzerland
Key inclusion criteria (2 listed)
- Kidney transplantation
- Chronic hemodialysis treatment
Key exclusion criteria (0 listed)
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2011.
Related trials for Aspergillosis
RecruitingObservational study
Natural History of Individuals With Immune System Problems That Lead to Fungal Infections
Chronic Mucocutaneous Candidiasis, Invasive Aspergillosis
RecruitingPhase 3
Compare Oral Itraconazole and Standard Care Versus Standard Care Alone in Patients With Non-cystic Fibrosis Related Bronchiectasis With Chronic Aspergillus Infection in Reducing Bronchiectasis Exacerbations
Bronchiectasis, Bronchiectasis Adult
Not yet recruitingPhase 3
A Study of Itraconazole and Posaconazole for Chronic Pulmonary Aspergillosis
Chronic Pulmonary Aspergillosis
Not yet recruiting
Real-World Effectiveness of Depemokimab in Allergic Bronchopulmonary Aspergillosis With Severe Eosinophilic Asthma
Allergic Bronchopulmonary Aspergillosis, ABPA
RecruitingPhase 3
A Trial to Compare Nebulized Amphotericin B and Nebulized Normal Saline as Maintenance in Patients With Chronic Pulmonary Aspergillosis
Chronic Pulmonary Aspergillosis, CPA
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.
Andreas Pasch, MD study director
University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aspergillosis, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 0 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: finished, as of the sponsor's last update on 20 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 May 2011.