Entry criteria for invasive aspergillosis in salvage caspofungin study1

Pulmonary: Pulmonary cases were either proven or probable diagnoses.

Proven pulmonary:  Tissue histopathology showing septate, acute, branching hyphae with or without a positive culture for Aspergillus species from the same site or, in the absence of histopathology, a positive culture from tissue obtained by an invasive procedure such as transbronchial biopsy or percutaneous needle aspiration.

Probable pulmonary

Patients with chest radiographic appearance consistent with invasive aspergillosis in the context of neutropenia, receipt of a cytotoxic agent for malignant or immunologic disease, corticosteroid dose of >10 mg prednisone or equivalent daily, or congenital or acquired immunodeficiency2,

and 2 sputum or 1 BAL culture positive for Aspergillus spp.

or positive for septate hyphae on microscopic or cytologic exam of BAL 

OR

Patients with chest CT consistent with invasive aspergillosis (‘halo’ sign or ‘air crescent’ sign)

and a positive direct (microscopic or cytologic) exam for hyphae

or culture of sputum or BAL for Aspergillus spp.,

or where available, positive galactomannan ELISA (aspergillus antigen) from BAL or serum (on at least 2 consecutive tests)

or at least 2 positive PCR tests for Aspergillus spp. in BAL.

Extrapulmonary: Extrapulmonary cases required a proven diagnosis

Single Organ

Histopathological evidence of invasion by Aspergillus with or without culture confirmation

or positive culture of Aspergillus spp. from deep sterile site, (obtained by needle aspiration or surgical biopsy)

Disseminated disease:  

Infection at ≥ 2 noncontiguous sites (one proven by histopathology or culture positive for Aspergillus spp.) or positive blood cultures for Aspergillus spp., (with supporting imaging data).

References

  1. Maertens J, Raad I, Sable CA, Ngai A, Berman R, Patterson TF, Denning DW, Walsh T. Multicenter, noncomparative study to evaluate safety and efficacy of caspofungin (CAS) in adults with invasive aspergillosis (IA) refractory (R) or intolerant (I) to amphotericin B (AMB), AMB lipid formulations (lipid AMB), or azoles.  Interscience Conference on Antimicrobial Agents and Chemotherapy, Toronto, Sept 16-20 2000.
  2. [Mycoses Study Group Criteria] Denning DW, Lee JY, Hostetler JS, Pappas P, Kauffman CA, Dewsnup DH, Galgiani JN, Graybill JR, Sugar AM, Catanzaro A, Gallis H, Perfect JR, Dockery B, Dismukes WE, Stevens DA, NIAID Mycoses Study Group multicenter trial of oral itraconazole therapy of invasive aspergillosis.  Am J Med 1994; 97: 135-144.

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