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

May 13, 2016 updated by: Prof. Dr. Oliver A. Cornely, University Hospital of Cologne

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

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • North Rhine-Westphalia
      • Cologne, North Rhine-Westphalia, Germany, 50924
        • University Hospital of Cologne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders 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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Pathological findings in chest CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival (%)
Time Frame: 48 weeks
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of Cologne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

May 6, 2013

First Submitted That Met QC Criteria

May 13, 2016

First Posted (Estimate)

May 16, 2016

Study Record Updates

Last Update Posted (Estimate)

May 16, 2016

Last Update Submitted That Met QC Criteria

May 13, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT_IPA_NEUT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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