Table 5. Responses to antifungal therapy in systemic histoplasmosis.
| Outcome, response | Criteria |
|---|---|
| Success | |
| Complete response | Survival and resolution of all attributable symptoms and signs of disease; plus |
| Resolution of radiological lesion(s); persistence of only a scar or postoperative changes can be equated with a complete radiological response; plus | |
| Documented clearance of infected sites that are accessible to repeated sampling (e.g., blood and CSF) | |
| If infected sites are not accessible to repeat sampling for cultures, clearance of Histoplasma antigen from serum and urine (if detected at baseline) can be used as a mycological criterion for complete response. | |
| Partial response | Survival and improvement of attributable symptoms and signs of disease; plus |
| Improvement in radiological lesions; plus | |
| Documented clearance of infected sites that are accessible to repeated sampling (e.g., blood and CSF) | |
| If infected sites are not accessible to repeated sampling for cultures, a decrease in the serum Histoplasma antigen level of at least 50% during the first 3 months of therapy, relative to the baseline level, can be equated with a partial mycological response | |
| Failure | |
| Stable response | Survival and minor or no improvement in attributable symptoms and signs of disease; plus |
| Radiological stabilization; or | |
| Persistently positive results of cultures of specimens from infected sites; or | |
| If infected sites are not accessible to repeated sampling for culture, lack of a decrease in the serum Histoplasma antigen level of at least 50% after 3 months of therapy can be equated with a stable mycological response | |
| Progression of disease | Worsening clinical symptoms or signs of disease; plus |
| New sites of disease or radiological worsening of preexisting lesions; or | |
| Persistently positive results of cultures of specimens from infected sites; or | |
| If infected sites are not accessible to repeated sampling for cultures, an increase in the serum Histoplasma antigen level of >20% can be a mycological criterion for worsening of disease | |
| Death | Death during the prespecified period of evaluation, regardless of attribution |
NOTE. Three months from time of initiation of study drug is a suggested minimum period of observation for systemic histoplasmosis. Because some patients develop relapsed disease while receiving antifungal therapy, assessment of outcome at 12 months after initiation of study drug is suggested as a secondary end point.