ECMM/MSGERC Clinical Trial Response Criteria
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- Outdated success criteria, requires new lens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.