Invasive Aspergillosis Clinical Trial
The incidence of invasive pulmonary aspergillosis (IPA) is increasing in all parts of the
world. Despite introduction of new antifungal agents for prophylaxis and treatment of IPA in
the last decade, the outcome of patients with IPA is still unsatisfactory and needs
improvement. Particularly, recent developments in diagnostic imaging, including introduction
of high-resolution computed tomography (CT) into standard procedures, made a place for
improvement of diagnosis of IPA.
Computed tomography of the chest is the optimal, recommended imaging procedure for diagnosis
of pneumonia in febrile neutropenic patients and it is significantly superior to
conventional chest X-ray. However, the method is associated with some difficulties mostly
due to the broad spectrum of pathological findings in patients with IPA and their evolution
over time. This has been described in retrospective studies on relatively small groups of
patients. Prospective studies on larger populations are still missing, as well as studies on
combination of different diagnostic modalities e.g. diagnostic imaging and microbiology.
We recently published the results of the clinical trial: "A Phase II Dose Escalation Study
of Caspofungin in Patients with Invasive Aspergillosis" which used caspofungin doses of 70
to 200 mg daily for the first line treatment of IPA. The maximum tolerated dose was not
reached, but response rates were impressive with complete plus partial responses accounting
for 54.3% and overall mortality at 12-week follow-up as low as 28.3%. There was a tendency
towards higher doses yielding higher response rates.
For the majority of these patients we obtained serial chest CT. So, for the first time a
patient population is at hand, in which the kinetics of infiltrates over time can be
described.
The main objective is to describe the pathological findings in chest CT performed
sequentially in IPA patients while receiving effective antifungal therapy. The specific
objectives are:
1. Characteristics of pathological findings in sequential chest CTs
- To describe the pathological findings (e.g. halo sign, air crescent sign and air
consolidation) in sequential high resolution computed tomogrphy (HRCT)
examinations
- To calculate the incidence of individual pathological findings in sequential CT
examinations
- To calculate a total volume of fungal infiltrates in sequential CT examinations
2. Correlation of pathological findings in sequential CT with corresponding white blood
count (WBC) and absolute neutrophil count (ANC)
- To correlate the appearance or disappearance of individual pathological findings
with WBC and ANC
- To correlate the volume of fungal infiltrates in sequential CT examinations with
WBC and absolute neutrophil count
3. Correlation of pathological findings in sequential CT with the serum galactomannan
index
- To correlate the appearance or disappearance of individual pathological findings
with the serum galactomannan index
- To correlate the volume of fungal infiltrates in sequential HRCT examinations with
the serum galactomannan index
4. Correlation of pathological findings in sequential HRCT with outcome of IFI
- To correlate the appearance or disappearance of individual pathological findings
with outcome of IFI
- To correlate the volume of fungal infiltrates in sequential HRCT examinations with
outcome of IFI
n/a
Observational Model: Cohort, Time Perspective: Retrospective
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