Utility of Diagnostic Criteria for Invasive Aspergillosis: Consistency of Diagnosis in a Clinical Trial.
Background: Lack of standardized diagnostic criteria has made entry of patients into clinical trials of invasive aspergillosis difficult. We established criteria including radiological findings to facilitate diagnosis. Methods: Review teams of clinicians and radiologists in Europe and USA jointly established diagnostic criteria and separately reviewed cases enrolled in a clinical trial for eligibility. Definite cases required positive histopathology and culture while probable cases required positive cultures with defined clinical and/or radiological findings in appropriate hosts. A neutropenic or BMT patient with a CT ``halo or ``air crescent was defined as probable invasive pulmonary aspergillosis. The initial 40 patients enrolled were reviewed by each team and the results compared to assess consistency of study entry as determined by the blinded review teams and study investigators. Results: Of the initial 40 patients enrolled, 36/40 (90%) were defined by both teams as meeting established criteria for definite or probable invasive aspergillosis. Four patients were determined by one of the teams to have probable infection but were not confirmed by the other panel to meet eligibility requirements based on the presence of other diagnoses, lack of documentation of infection, and others. Both radiographic and clinical features were interpreted consistently by each of the panels. Conclusion: These results show that these diagnostic criteria including radiological findings of a halo or air crescent can be consistently applied for entry of patients into a clinical trial. Early detection of invasive aspergillosis may be a means to facilitate patient enrollment in clinical trials and may ultimately lead to improved outcome of infection in patients with this lethal disease.
Full conference title:
Abstracts of the 40th Interscience Conference on Antimicrobial Agents and Chemotherapy