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Surveillance of Azole Resistance in Aspergillus Isolates in Taiwan

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ClinicalTrials.gov Identifier: NCT03024281
Recruitment Status : Recruiting
First Posted : January 18, 2017
Last Update Posted : January 18, 2017
Sponsor:
Collaborator:
National Health Research Institutes, Taiwan
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief 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. To characterize the molecular mechanisms of azole resistance in Aspergillus isolates in Taiwan
  4. To investigate the clonality of Aspergillus clinical and environmental isolates in Taiwan
  5. To describe the genetic relationships between local resistant strains with global strains

Secondary objective:

  1. To describe the clinical characteristics and treatment outcome of patients with proven or probable invasive aspergillosis
  2. To evaluate the clinical impact of azole resistance in patients with proven or probable invasive aspergillosis in a case-control study

Condition or disease
Infection; Aspergillus

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 Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Surveillance of Azole Resistance in Aspergillus
Study Start Date : July 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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."


Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: 6 weeks after diagnosis of proven or probable invasive aspergillosis ]
    The proportion of non-survivors. Discharge against medical advice and in critical condition and lost to follow up will categorized as mortality.

  2. All-cause mortality [ Time Frame: 12 weeks after diagnosis of proven or probable invasive aspergillosis ]
    The proportion of non-survivors. Discharge against medical advice and in critical condition and lost to follow up will categorized as mortality.

  3. Breakthrough mold infections [ Time Frame: 6 weeks after diagnosis of proven or probable invasive aspergillosis ]
    The proportion of patients with breakthrough mold infections

  4. Breakthrough invasive fungal diseases [ Time Frame: 12 weeks after diagnosis of proven or probable invasive aspergillosis ]
    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

  5. Treatment success [ Time Frame: 12 weeks after diagnosis of proven or probable invasive aspergillosis ]
    The proportion of patients with complete response or partial response.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

For primary objectives

Inclusion Criteria:

  • Patients with one or more clinical specimens culture positive of Aspergillus

Exclusion Criteria:

  • Is not a human pathogen of Aspergillus
  • no clinical data available

For secondary objectives (a case-control study in a 1:4 ratio)

Inclusion Criteria:

  • patients with proven or probable invasive aspergillosis

Case patients: patients infected by azole-resistant isolates Control patients: patients infected by azole-susceptible isolates


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03024281


Contacts
Contact: Chen Yee-Chun, MD, PhD 886-2-23123456 ext 65908 yeechunchen@gmail.com
Contact: ICMJE

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Chen Yee-Chun, MD, PhD    886-2-23123456 ext 65908    yeechunchen@gmail.com   
Sponsors and Collaborators
National Taiwan University Hospital
National Health Research Institutes, Taiwan
Investigators
Study Director: WHO, ICMJE WHO and ICMJE WHO and ICMJE

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03024281     History of Changes
Other Study ID Numbers: 201605098RIPA
First Posted: January 18, 2017    Key Record Dates
Last Update Posted: January 18, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by National Taiwan University Hospital:
Aspergillus
Antifungal susceptibility
Azole resistance

Additional relevant MeSH terms:
Aspergillosis
Mycoses
Hyalohyphomycosis
Dermatomycoses
Lung Diseases, Fungal
Skin Diseases, Infectious
Skin Diseases