Infection; AspergillusNCT03024281
Surveillance of Azole Resistance in Aspergillus Isolates in Taiwan
An observational study of Infection; Aspergillus, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Primary objectives: 1. To investigate the prevalence of azole resistance in Aspergillus clinical isolates collected in participating hospitals in Taiwan 2. To investigate the prevalence of azole resistance in Aspergillus environmental isolates in Taiwan 3. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infection; Aspergillus
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2016to Dec 2018
- 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: A total of 10 hospitals located in different geographic location of Taiwan will be invited to participate this project. These hospitals are selected based on three criteria: better quality of routine microbiology laboratory (not reference laboratory), one or more physicians or microbiologists who are interested in medical mycology, and geographic location of the hospitals.
Who may be able to join
- Patients with one or more clinical specimens culture positive of Aspergillus
- patients with proven or probable invasive aspergillosis
- Case patients: patients infected by azole-resistant isolates Control patients: patients infected by azole-susceptible isolates
Who cannot join
- Is not a human pathogen of Aspergillus
- no clinical data available
- For secondary objectives (a case-control study in a 1:4 ratio)
Trial locations and contacts
1 site in 1 country.
ICMJE contact
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, Taipei, 100
Chen Yee-Chun, MD, PhD, 886-2-23123456 ext. 65908, yeechunchen@gmail.com
About this study
Official title: Surveillance of Azole Resistance in Aspergillus
Primary objectives:
- To investigate the prevalence of azole resistance in Aspergillus clinical isolates collected in participating hospitals in Taiwan
- To investigate the prevalence of azole resistance in Aspergillus environmental isolates in Taiwan
- To characterize the molecular mechanisms of azole resistance in Aspergillus isolates in Taiwan
- To investigate the clonality of Aspergillus clinical and environmental isolates in Taiwan
- To describe the genetic relationships between local resistant strains with global strains
Read more
Secondary objective:
- To describe the clinical characteristics and treatment outcome of patients with proven or probable invasive aspergillosis
- To evaluate the clinical impact of azole resistance in patients with proven or probable invasive aspergillosis in a case-control study
Read the detailed description
Cumulative evidence described the emergence and geographical expansion of azole-resistant Aspergillus fumigatus associated with azole treatment failure. Multiple amino acid substitutions in the cyp51A gene have been described to be associated with azole resistance that emerges during azole treatment, while a resistance mechanism, TR34/L98H mutation in cyp51A, has been linked to the agricultural use of azole fungicides in Europe, which have also been widely used in Taiwan for years. The current prevalence of azole-resistant Aspergillus isolates and mechanisms of azole resistance in Taiwan is not clear. Considering the potential of geographic migration of resistant isolates from neighboring countries and the possibility of emergence of locally revolved resistant strains, this 2-year multi-center project aims to investigate the prevalence rate of azole resistance in Aspergillus clinical and environmental isolates, to determine the molecular mechanisms of azole resistance, and to describe the clinical characteristics and treatment outcome of Aspergillus diseases in Taiwan. Clinical and environmental Aspergillus isolates will be collected and examined, and clinical data from patients with Aspergillus diseases or colonization will be retrieved and analyzed. Through this study the investigators anticipate increase in awareness of prevalence and impact of azole resistance in patient safety in participating hospitals. In addition, the investigators may update Taiwan treatment guideline for aspergillosis on the basis of these evidence and knowledge.
- Conditions
- Infection; Aspergillus
- Keywords
- Aspergillus, Antifungal susceptibility, Azole resistance
- Medical subject headings
- Aspergillosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment success
The proportion of patients with complete response or partial response according to the definition described in "Segal BH, Herbrecht R, Stevens DA, Ostrosky-Zeichner L, Sobel J, Viscoli C, et al. Defining responses to therapy and study outcomes in clinical trials of invasive fungal diseases: Mycoses Study Group and European Organization for Research and Treatment of Cancer consensus criteria. Clin Infect Dis. Sep 1 2008;47(5):674-683."
Measured: 6 weeks after diagnosis of proven or probable invasive aspergillosis
Secondary outcomes (5)
All-cause mortality
The proportion of non-survivors. Discharge against medical advice and in critical condition and lost to follow up will categorized as mortality.
Measured: 6 weeks after diagnosis of proven or probable invasive aspergillosis
All-cause mortality
The proportion of non-survivors. Discharge against medical advice and in critical condition and lost to follow up will categorized as mortality.
Measured: 12 weeks after diagnosis of proven or probable invasive aspergillosis
Breakthrough mold infections
The proportion of patients with breakthrough mold infections
Measured: 6 weeks after diagnosis of proven or probable invasive aspergillosis
Breakthrough invasive fungal diseases
The proportion of patients with breakthrough invasive fungal diseases defined as occurrence of a proven or probable invasive fungal diseases according to EORTC/MSG revised definitions while on systemic antifungal therapy or within 15 days of discontinuation of antifungal use
Measured: 12 weeks after diagnosis of proven or probable invasive aspergillosis
Treatment success
The proportion of patients with complete response or partial response.
Measured: 12 weeks after diagnosis of proven or probable invasive aspergillosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study startJul 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection; AspergillusStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan
- Responsible party
- Sponsor
- Investigators
- WHO, ICMJE WHO and ICMJE, Study director, WHO and ICMJE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03024281
- Sponsor's protocol ID
- 201605098RIPA
- Status last verified
- Jan 2017
- First submitted
- 21 Nov 2016
- Last updated
- 18 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surveillance of Azole Resistance in Aspergillus
- ClinicalTrials.gov ID
- NCT03024281
- Acronym / sponsor ID
- 201605098RIPA
- Conditions
- Infection; Aspergillus
- Keywords
- Aspergillus, Antifungal susceptibility, Azole resistance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan
- Study start
- Jul 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 18 Jan 2017 (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.
Primary objectives:
- To investigate the prevalence of azole resistance in Aspergillus clinical isolates collected in participating hospitals in Taiwan
- To investigate the prevalence of azole resistance in Aspergillus environmental isolates in Taiwan
- To characterize the molecular mechanisms of azole resistance in Aspergillus isolates in Taiwan
- To investigate the clonality of Aspergillus clinical and environmental isolates in Taiwan
- To describe the genetic relationships between local resistant strains with global strains
Secondary objective:
- To describe the clinical characteristics and treatment outcome of patients with proven or probable invasive aspergillosis
- To evaluate the clinical impact of azole resistance in patients with proven or probable invasive aspergillosis in a case-control study
Detailed description
Cumulative evidence described the emergence and geographical expansion of azole-resistant Aspergillus fumigatus associated with azole treatment failure. Multiple amino acid substitutions in the cyp51A gene have been described to be associated with azole resistance that emerges during azole treatment, while a resistance mechanism, TR34/L98H mutation in cyp51A, has been linked to the agricultural use of azole fungicides in Europe, which have also been widely used in Taiwan for years. The current prevalence of azole-resistant Aspergillus isolates and mechanisms of azole resistance in Taiwan is not clear. Considering the potential of geographic migration of resistant isolates from neighboring countries and the possibility of emergence of locally revolved resistant strains, this 2-year multi-center project aims to investigate the prevalence rate of azole resistance in Aspergillus clinical and environmental isolates, to determine the molecular mechanisms of azole resistance, and to describe the clinical characteristics and treatment outcome of Aspergillus diseases in Taiwan. Clinical and environmental Aspergillus isolates will be collected and examined, and clinical data from patients with Aspergillus diseases or colonization will be retrieved and analyzed. Through this study the investigators anticipate increase in awareness of prevalence and impact of azole resistance in patient safety in participating hospitals. In addition, the investigators may update Taiwan treatment guideline for aspergillosis on the basis of these evidence and knowledge.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A total of 10 hospitals located in different geographic location of Taiwan will be invited to participate this project. These hospitals are selected based on three criteria: better quality of routine microbiology laboratory (not reference laboratory), one or more physicians or microbiologists who are interested in medical mycology, and geographic location of the hospitals.
Key inclusion criteria (3 listed)
- Patients with one or more clinical specimens culture positive of Aspergillus
- patients with proven or probable invasive aspergillosis
- Case patients: patients infected by azole-resistant isolates Control patients: patients infected by azole-susceptible isolates
Key exclusion criteria (3 listed)
- Is not a human pathogen of Aspergillus
- no clinical data available
- For secondary objectives (a case-control study in a 1:4 ratio)
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
Treatment success
Time frame: 6 weeks after diagnosis of proven or probable invasive aspergillosis
The proportion of patients with complete response or partial response according to the definition described in "Segal BH, Herbrecht R, Stevens DA, Ostrosky-Zeichner L, Sobel J, Viscoli C, et al. Defining responses to therapy and study outcomes in clinical trials of invasive fungal diseases: Mycoses Study Group and European Organization for Research and Treatment of Cancer consensus criteria. Clin Infect Dis. Sep 1 2008;47(5):674-683."
5 secondary outcomes
All-cause mortality
Time frame: 6 weeks after diagnosis of proven or probable invasive aspergillosis
All-cause mortality
Time frame: 12 weeks after diagnosis of proven or probable invasive aspergillosis
Breakthrough mold infections
Time frame: 6 weeks after diagnosis of proven or probable invasive aspergillosis
Breakthrough invasive fungal diseases
Time frame: 12 weeks after diagnosis of proven or probable invasive aspergillosis
Treatment success
Time frame: 12 weeks after diagnosis of proven or probable invasive aspergillosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2017.
- Individual participant dataSharing planned: Undecided
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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.
ICMJE contact
WHO, ICMJE WHO and ICMJE study director
WHO and ICMJE
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 Infection; Aspergillus, run by National Taiwan University Hospital at 1 site in Taiwan.
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 3 inclusion and 3 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 18 Jan 2017. 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 Taiwan. 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?
Contact Chen Yee-Chun, MD, PhD (886-2-23123456 ext. 65908, yeechunchen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment success (time frame: 6 weeks after diagnosis of proven or probable invasive aspergillosis). 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 18 Jan 2017.