Pulmonary AspergillosisNCT03443336
Azole-resistance in Aspergillus
An observational study of Pulmonary Aspergillosis, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Prospective multi-center surveillance study on the prevalence of azole-resistant Aspergillus spp. in clinical isolates of patients with pulmonary colonization or invasive infections in Switzerland Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Aspergillosis
- How many people
- 400 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jun 2017to 2 Jun 2021
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with a respiratory sample growing Aspergillus spp., will be included
Who may be able to join
- Available respiratory sample growing Aspergillus spp.
- Available clinical data
Who cannot join
- refusal to sign the general consent
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Division of Infectious Diseases and Hospital Epidemiology
Basel, 4031
About this study
Official title: Prospective Multi-center Surveillance Study on the Prevalence of Azole-resistant Aspergillus Spp. in Clinical Isolates ot Patients With Pulmonary Colonization or Invasive Infections in Switzerland
Prospective multi-center surveillance study on the prevalence of azole-resistant Aspergillus spp. in clinical isolates of patients with pulmonary colonization or invasive infections in Switzerland
Read the detailed description
Azole-resistance in Aspergillus (A.) fumigatus has emerged as a global health problem. Even more, it has been associated with high mortality rates in patients with invasive aspergillosis.
Generally, two routes of resistance development are distinguished either in patients with chronic pulmonary aspergillosis under long-term azole therapy or in agriculture by the use of azoles as fungicides.
The primary mechanisms of resistance that have been described in clinical strains include different point mutations in the cyp51A gene, which encodes the enzyme responsible for converting lanosterol to ergosterol via demethylation. Some resistant isolates also contain a tandem repeat in the promoter region of this gene that causes increased expression. These mutations, including TR34/L98H and TR46/Y121F/T289A have been identified in the environment and have been demonstrated to cause resistance to azole fungicides used in agriculture. These mutations were also recently identified in haematological patients suffering from invasive aspergillosis and were associated with a mortality rate of 88%.
Studies on the frequency of azole resistance in Aspergillus culture collections report the first resistant isolates up to 20 years earlier than clinical and environmental studies. Since then, microbiological resistance to azoles and clinical failures associated with this resistance have been reported in several countries in Europe and elsewhere. The United Kingdom and the Netherlands have reported increases in azole-resistant A. fumigatus. In the United Kingdom, a statistically significant increase in azole resistance was noted between 2004 and 2009, with rates of 5 to 7% in 2004 to 2006 increasing to up to 20% in 2009. These isolates were collected primarily in patients who received long-term azole therapy for the treatment of chronic pulmonary aspergillosis. The observation has increased the awareness of azole resistance in this patient population. Surveillance studies and case series over the last years suggest the global presence of azole resistance in A. fumigatus, including in Europe, the Middle East, Asia, Africa, Australia and, most recently, North and South America.
Moreover, some cryptic species of Aspergillus section Fumigati (e.g. A. lentulus, A. udagawae), which cannot be reliably distinguished from A. fumigatus by standard diagnostic methods, account for 3-5% of all A. fumigatus sensu lato clinical isolates and exhibit some level of intrinsic azole resistance. The proportion of these cryptic species in other Aspergillus sections (e.g. Flavi, Nigri, Terrei) is relatively unexplored. In addition, some rare Aspergillus species with intrinsic azole resistance, such as Aspergillus calidoustus (section Usti) are emerging as opportunistic pathogens in patients receiving azole prophylaxis. These cryptic or rare Aspergillus spp. are often misidentified because of the lack of discrimination by standard microbiological methods. Thus, their actual clinical relevance is unknown.
In Switzerland, comprehensive data on azole resistance in A. fumigatus are lacking. The major reason for this is the lack of routine testing of in vitro susceptibility of A. fumigatus isolates in most microbiology laboratories.
The Fungal Infections Network of Switzerland (FUNGINOS) offers an optimal platform to comprehensively assess the epidemiology of azole-resistance in A. fumigates and other Aspergillus spp. Only recently invasive Candida infections (candidemia) have been prospectively monitored by FUNGINOS over ten years from 2004 to 2013 in all Swiss University clinics and 20 University-affiliated hospitals.
- Conditions
- Pulmonary Aspergillosis
- Medical subject headings
- Pulmonary Aspergillosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Azole-resistance in Aspergillus (A.) fumigatus
Distribution of antifungal susceptibility profile of all tracheal and urinary samples in clinical Aspergillus isolates
Measured: start of study until end of study (July 2017 until December 2018)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study start1 Jun 2017
- Primary completion30 Jun 2019
- Study completion2 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary 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
- Other
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nina Khanna, Prof MD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03443336
- Sponsor's protocol ID
- 2017-00984; me17Khanna
- Other IDs
- 2017
- Status last verified
- Jun 2021
- First submitted
- 9 Feb 2018
- Last updated
- 3 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multi-center Surveillance Study on the Prevalence of Azole-resistant Aspergillus Spp. in Clinical Isolates ot Patients With Pulmonary Colonization or Invasive Infections in Switzerland
- ClinicalTrials.gov ID
- NCT03443336
- Acronym / sponsor ID
- 2017-00984; me17Khanna
- Conditions
- Pulmonary Aspergillosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 2 Jun 2021 (actual)
- First posted
- 23 Feb 2018 (actual)
- 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.
Prospective multi-center surveillance study on the prevalence of azole-resistant Aspergillus spp. in clinical isolates of patients with pulmonary colonization or invasive infections in Switzerland
Detailed description
Azole-resistance in Aspergillus (A.) fumigatus has emerged as a global health problem. Even more, it has been associated with high mortality rates in patients with invasive aspergillosis.
Generally, two routes of resistance development are distinguished either in patients with chronic pulmonary aspergillosis under long-term azole therapy or in agriculture by the use of azoles as fungicides.
The primary mechanisms of resistance that have been described in clinical strains include different point mutations in the cyp51A gene, which encodes the enzyme responsible for converting lanosterol to ergosterol via demethylation. Some resistant isolates also contain a tandem repeat in the promoter region of this gene that causes increased expression. These mutations, including TR34/L98H and TR46/Y121F/T289A have been identified in the environment and have been demonstrated to cause resistance to azole fungicides used in agriculture. These mutations were also recently identified in haematological patients suffering from invasive aspergillosis and were associated with a mortality rate of 88%.
Studies on the frequency of azole resistance in Aspergillus culture collections report the first resistant isolates up to 20 years earlier than clinical and environmental studies. Since then, microbiological resistance to azoles and clinical failures associated with this resistance have been reported in several countries in Europe and elsewhere. The United Kingdom and the Netherlands have reported increases in azole-resistant A. fumigatus. In the United Kingdom, a statistically significant increase in azole resistance was noted between 2004 and 2009, with rates of 5 to 7% in 2004 to 2006 increasing to up to 20% in 2009. These isolates were collected primarily in patients who received long-term azole therapy for the treatment of chronic pulmonary aspergillosis. The observation has increased the awareness of azole resistance in this patient population. Surveillance studies and case series over the last years suggest the global presence of azole resistance in A. fumigatus, including in Europe, the Middle East, Asia, Africa, Australia and, most recently, North and South America.
Moreover, some cryptic species of Aspergillus section Fumigati (e.g. A. lentulus, A. udagawae), which cannot be reliably distinguished from A. fumigatus by standard diagnostic methods, account for 3-5% of all A. fumigatus sensu lato clinical isolates and exhibit some level of intrinsic azole resistance. The proportion of these cryptic species in other Aspergillus sections (e.g. Flavi, Nigri, Terrei) is relatively unexplored. In addition, some rare Aspergillus species with intrinsic azole resistance, such as Aspergillus calidoustus (section Usti) are emerging as opportunistic pathogens in patients receiving azole prophylaxis. These cryptic or rare Aspergillus spp. are often misidentified because of the lack of discrimination by standard microbiological methods. Thus, their actual clinical relevance is unknown.
In Switzerland, comprehensive data on azole resistance in A. fumigatus are lacking. The major reason for this is the lack of routine testing of in vitro susceptibility of A. fumigatus isolates in most microbiology laboratories.
The Fungal Infections Network of Switzerland (FUNGINOS) offers an optimal platform to comprehensively assess the epidemiology of azole-resistance in A. fumigates and other Aspergillus spp. Only recently invasive Candida infections (candidemia) have been prospectively monitored by FUNGINOS over ten years from 2004 to 2013 in all Swiss University clinics and 20 University-affiliated hospitals.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with a respiratory sample growing Aspergillus spp., will be included
Key inclusion criteria (2 listed)
- Available respiratory sample growing Aspergillus spp.
- Available clinical data
Key exclusion criteria (1 listed)
- refusal to sign the general consent
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
Azole-resistance in Aspergillus (A.) fumigatus
Time frame: start of study until end of study (July 2017 until December 2018)
Distribution of antifungal susceptibility profile of all tracheal and urinary samples in clinical Aspergillus isolates
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 3 Jun 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Pulmonary Aspergillosis
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
Not yet recruitingPhase 1
Deposition of Inhaled Liposomal Amphotericin B in Chronic Pulmonary Aspergillosis (CPA)
Chronic Pulmonary Aspergillosis
Active, not recruitingPhase 2
Interferon-gamma as Adjunctive Therapy in Chronic Pulmonary Aspergillosis: a Randomised Feasibility Study
Chronic Pulmonary Aspergillosis, Aspergillosis
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.
Nina Khanna, Prof MD principal investigator
University Hospital, Basel, Switzerland
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 Pulmonary Aspergillosis, run by University Hospital, Basel, Switzerland 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 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: finished, as of the sponsor's last update on 3 Jun 2021. 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.
What does the primary outcome measure?
Azole-resistance in Aspergillus (A.) fumigatus (time frame: start of study until end of study (July 2017 until December 2018)). 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 3 Jun 2021.