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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

Tracking Information
First Submitted Date May 6, 2013
First Posted Date May 16, 2016
Last Update Posted Date May 16, 2016
Study Start Date June 2013
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 13, 2016)
Overall survival (%) [ Time Frame: 48 weeks ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title An Evaluation of Sequential Computed Tomography of the Chest in Management of Invasive Pulmonal Aspergillosis in Neutropenic Patients With Haematological Malignancies
Official Title Not Provided
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
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Immunocompromised patients with proven or probable invasive aspergillosis received caspofungin once daily as an intravenous infusion
Condition Invasive Aspergillosis
Intervention Not Provided
Study Groups/Cohorts Pathological findings in chest CT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: May 13, 2016)
40
Original Estimated Enrollment Same as current
Study Completion Date Not Provided
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT02773342
Other Study ID Numbers CT_IPA_NEUT
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Prof. Dr. Oliver A. Cornely, University Hospital of Cologne
Study Sponsor University Hospital of Cologne
Collaborators Not Provided
Investigators Not Provided
PRS Account University Hospital of Cologne
Verification Date May 2016