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An Evaluation of Sequential Computed Tomography of the Chest in Management of Invasive Pulmonal Aspergillosis in Neutropenic Patients With Haematological Malignancies

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ClinicalTrials.gov Identifier: NCT02773342
Recruitment Status : Unknown
Verified May 2016 by Prof. Dr. Oliver A. Cornely, University Hospital of Cologne.
Recruitment status was:  Not yet recruiting
First Posted : May 16, 2016
Last Update Posted : May 16, 2016
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Oliver A. Cornely, University Hospital of Cologne

Brief Summary:

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

Condition or disease
Invasive Aspergillosis

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Retrospective
Study Start Date : June 2013
Actual Primary Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aspergillosis

Group/Cohort
Pathological findings in chest CT



Primary Outcome Measures :
  1. Overall survival (%) [ Time Frame: 48 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Immunocompromised patients with proven or probable invasive aspergillosis received caspofungin once daily as an intravenous infusion
Criteria

Inclusion Criteria:

  • At least two subsequent, evaluable CT examinations of the chest performed while on study

Exclusion Criteria:

  • Diagnosis of underlying disease other than haematological malignancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02773342


Contacts
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Contact: Jörg-Janne Vehreschild, MD +0049 (0)221 478-6494 janne.vehreschild@ctuc.de
Contact: Oliver Cornely, MD +0049 (0)221 478-6494 oliver.cornely@ctuc.de

Locations
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Germany
University Hospital of Cologne
Cologne, North Rhine-Westphalia, Germany, 50924
Contact: Jörg-Janne Vehreschild, MD    +0049 (0)221 478-6494    janne.vehreschild@ctuc.de   
Contact: Oliver Cornely, MD    0049 (0)221 478-6494    oliver.cornely@ctuc.de   
Sponsors and Collaborators
University Hospital of Cologne
Additional Information:
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Responsible Party: Prof. Dr. Oliver A. Cornely, University Hospital of Cologne
ClinicalTrials.gov Identifier: NCT02773342    
Other Study ID Numbers: CT_IPA_NEUT
First Posted: May 16, 2016    Key Record Dates
Last Update Posted: May 16, 2016
Last Verified: May 2016
Keywords provided by Prof. Dr. Oliver A. Cornely, University Hospital of Cologne:
Invasive Pulmonal Aspergillosis
Neutropenic Patients
Haematological Malignancies
Chest Computed Tomography
Additional relevant MeSH terms:
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Aspergillosis
Mycoses