Collaborative Project Purpose
Redefine clinical mycology response criteria for clinical trials and clinical treatment that were initially published by Segal et al., 2008.
Why is this important today?
- Outdated success criteria, requires new lens
- Lock innovation: current diagnostics, "Real World" approaches, new study methodologies
- Lack of patient important outcomes, patient input
- Set the stage for DOOR criteria
General Response Criteria
Segal et al 2008
Clin Infect Dis 47(5): 674-683
doi: 10.1086/590566
| OUTCOME, RESPONSE | CRITERIA |
|---|---|
|
SUCCESS Complete Response |
Survival within the prespecified period of observation, resolution of all attributable S/S of disease and radiologic abnormalities, and mycological evidence of eradication of disease |
| Partial Response | Survival within the prespecified period of observation, improvement of attributable S/S of disease and radiological abnormalities, and evidence of clearance of cultures or reduction of fungal burden, as assessed by a quantitative and validated laboratory marker. |
|
FAILURE Stable Response* |
Survival within the prespecified period of observation and minor or no improvement in fungal disease, but no evidence of progression, as determined based on a composite clinical, radiological criterion. |
| Progression of fungal disease | Evidence of progressive fungal disease based on a composite of clinical, radiological, and mycological criteria. |
| Death | Death during the prespecified period of evaluation, regardless of attribution. |
*In certain invasive fungal disease (e.g., invasive mold disease), stabilization of fungal disease during periods of severe immunocompromise provides evidence of efficacy of treatment and may be a reasonable short-term therapeutic goal until immune recovery occurs.