NCT01178177

Brief Summary

Invasive pulmonary aspergillosis (IPA) is an opportunistic infection that primarily affects recipients of solid organ transplants (SOTs) and patients with chemotherapy- induced neutropenia.Although both of these populations are at high risk for IPA, they differ with regards to the specific defects in host defense mechanisms that increase their risk for IPA. Chemotherapy- induced neutropenia is the principal defect affecting patients with hematologic malignancies, whereas transplant recipients tend to have dysfunctional T cells and phagocytes, as a result of immunosuppressive drug therapy. Thus, the patterns of IPA-related infection and inflammation may differ according to the type of underlying immune defect. Although the clinical and radiological features of IPA in patients with neutropenia have been extensively studied, little is known about the characteristics of IPA in SOT recipients. The investigators therefore compared the IPA- related clinical and radiological findings in SOT recipients with those of neutropenic patients.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2008

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 10, 2010

Completed
Last Updated

May 16, 2013

Status Verified

May 1, 2013

Enrollment Period

2.1 years

First QC Date

August 9, 2010

Last Update Submit

May 14, 2013

Conditions

Keywords

Invasive pulmonary aspergillosisSolid organ transplantationHematologic disease

Study Arms (2)

SOT recipients

solid organ transplant recipients with invasive pulmonary aspergillosis

Hematologic disease

Hematologic disease patients with invasive pulmonary aspergillosis

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All adult patients who are diagnosed with invasive pulmonary aspergillosis (IPA)between January 2008 and February 2010.

You may qualify if:

  • IPA cases with solid organ transplant recipients and hematologic disease patients
  • proven and probable invasive pulmonary aspergillosis by modified EORTC/MSG criteria

You may not qualify if:

  • under 16 years old
  • possible cases of invasive pulmonary aspergillosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Park SY, Lim C, Lee SO, Choi SH, Kim YS, Woo JH, Song JW, Kim MY, Chae EJ, Do KH, Song KS, Seo JB, Kim SH. Computed tomography findings in invasive pulmonary aspergillosis in non-neutropenic transplant recipients and neutropenic patients, and their prognostic value. J Infect. 2011 Dec;63(6):447-56. doi: 10.1016/j.jinf.2011.08.007. Epub 2011 Aug 16.

MeSH Terms

Conditions

Hematologic DiseasesInvasive Pulmonary Aspergillosis

Condition Hierarchy (Ancestors)

Hemic and Lymphatic DiseasesPulmonary AspergillosisAspergillosisMycosesBacterial Infections and MycosesInfectionsInvasive Fungal InfectionsLung Diseases, FungalLung DiseasesRespiratory Tract Diseases

Study Officials

  • Sung-Han Kim, MD

    Department of Infectious Diseases, Asan Medical Center

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistantant Professor

Study Record Dates

First Submitted

August 9, 2010

First Posted

August 10, 2010

Study Start

January 1, 2008

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

May 16, 2013

Record last verified: 2013-05