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Detection of Invasive Pulmonary Aspergillosis in Haematological Malignancy Patients by using Lateral-flow Technology
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Impact of Changes of the 2020 Consensus Definitions of Invasive Aspergillosis on Clinical Trial Design: Unintended

John R Wingard1, Barbara D Alexander2, Lindsey R Baden3

  • 1Department of Medicine, University of Florida College of Medicine, Gainesville, Florida, USA.

Open Forum Infectious Diseases
|October 11, 2021
PubMed
Abstract

Insights

The 2020 invasive fungal disease (IFD) definitions reduced the classification of probable invasive aspergillosis (IA) cases. This impacts clinical trial design, particularly for antifungal prophylaxis studies in immunocompromised patients.

Area of Science:

  • Medical Mycology
  • Clinical Trials
  • Infectious Diseases

Background:

  • Consensus definitions for invasive fungal diseases (IFDs) were updated in 2020 to enhance diagnostic certainty for clinical trials.
  • The impact of these revised definitions on clinical trial outcomes remains largely unexamined.

Purpose of the Study:

  • To evaluate the effect of the 2020 updated consensus definitions on the classification of invasive aspergillosis (IA).
  • To assess the implications of these changes for clinical trial design, specifically in antifungal prophylaxis studies.

Main Methods:

  • Reclassification of 226 proven/probable IA cases and 139 possible IFD cases using the 2020 criteria.
  • Analysis of cases from the Aspergillus Technology Consortium (AsTeC) and the BMT CTN 0101 antifungal prophylaxis trial.

Main Results:

  • Fewer cases met the stringent 2020 criteria for probable IA.
  • 22% of evaluable probable IA cases were reclassified to possible IFD.
  • Diagnosis date was delayed by a median of 3 days for 15% of probable IA cases.
  • Antifungal prophylaxis trial power decreased substantially under the new definitions.

Conclusions:

  • The updated 2020 IA consensus definitions necessitate adjustments in clinical trial designs.
  • These changes may particularly affect antifungal prophylaxis studies by altering case ascertainment and statistical power.
Keywords:
antifungal clinical trialsantifungal prophylaxisantifungal treatmentinvasive aspergillosisinvasive fungal diseases

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