Blastomycosis Clinical Trial
Official title:
Case Series of Continuously-infused Amphotericin-B and Follow-up Voriconazole Therapy for Severe Blastomycosis Pulmonary Infections
All patients with pulmonary blastomycosis requiring mechanical ventilation will have their blood concentrations measured for the antifungal drugs, amphotericin-B and voriconazole; as well as an analysis of the susceptibility of their infecting species of blastomyces. This information will then be analyzed relative to their rate of clinical recovery from this serious fungal infection.
To evaluate six intensively studied patients admitted to medical intensive care with
pulmonary blastomycosis requiring mechanical ventilation. Interventionally, all patients will
receive continuously infused amphotericin-B (1 mg/kg/d); and then stepped down to oral or
i.v. voriconazole once clinically responding. Blood will be sampled for amphotericin-B
concentrations for the 3 first days (i.e. one blood sample per day); and when eventually
changed over to voriconazole (i.e. generally after a total dose of 1 g has been reached of
Amphotericin-B; as per usual practice). Once switched to oral or intravenous voriconazole, at
the treating physicians discretion, then blood would once again be sampled for the next 3
days for voriconazole concentrations. MIC's of the infecting blastomyces would also be
analyzed. The fungal isolate would be sent off to the Fungus Testing Laboratory at the
University of Texas in San Antonio for susceptibility testing.
Clinical response to therapy relative to their initial pharmacokinetic and pharmacodynamic
indices for amphotericin-B (i.e. daily free maximal concentration divided by the MIC) would
be assessed in these 6 intensively studied patients. Clinical parameters assessed would be
1). time to fever defervescence; 2). time to white cell count resolution, and 3).
improvements in respiratory gas exchange (i.e. specifically the rate of rise of the pressure
of arterial oxygen (Pa02) divided by the fraction of inspired oxygen (Fi02) delivered through
the ventilator (or PF ratio).
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