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Diagnostic and Management Strategies for Invasive Aspergillosis

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ClinicalTrials.gov Identifier: NCT00816088
Recruitment Status : Completed
First Posted : December 31, 2008
Last Update Posted : December 23, 2014
Sponsor:
Information provided by (Responsible Party):
Mansour Ceesay, King's College Hospital NHS Trust

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Fungal infections caused by Aspergillus fumigatus are now identified in up to 45% of patients dying from haematological malignancy. There has been a significant increase in deaths from IA over the last 20 years. Our current diagnostic approach is neither sensitive nor specific. The purpose of this study is to prospectively assess the value of current diagnostic tools, as well as test other new diagnostic methods for the diagnosis of IA among haemato-oncology patients undergoing chemotherapy or stem cell transplantation.

Condition or disease
Invasive Aspergillosis Neutropenia

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Study Design
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Study Type : Observational
Actual Enrollment : 203 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diagnostic and Management Strategies for Invasive Aspergillosis in Neutropenic Adult Haemato-Oncology Patients With a Proposal for Investigation of a Novel Potential Marker for Early Diagnosis: a Prospective Cohort Study
Study Start Date : December 2008
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aspergillosis
U.S. FDA Resources

Groups and Cohorts
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Group/Cohort
neutropenia
Patients undergoing stem cell transplantation or chemotherapy likely to lead to prolonged neutropenia.


Outcome Measures
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Primary Outcome Measures :
  1. To determine the incidence of IFD using a comprehensive diagnostic approach [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Evaluation of established and experimental diagnostic methods [ Time Frame: 2-3 years ]
  2. Costing analysis [ Time Frame: 2-3 years ]
  3. Establish the prognostic value of CT appearances in patients with IA [ Time Frame: 2-3 years ]
  4. Assessing the value of methylene blue 'tattooing' prior to surgical biopsy [ Time Frame: 2-3 years ]

Biospecimen Retention:   Samples With DNA
Seum, Whole blood, urine, broncho-alveolar lavage, tissue

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Haemato-oncology patients undergoing high dose chemotherapy or stem cell transplantation likely to render them neutropenic.
Criteria

Inclusion Criteria:

  • All adult haemato-oncology patients admitted for transplant or high dose chemotherapy and able to consent.

Exclusion Criteria:

  • children (< 18 years old) or inability or refusal to consent.
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT00816088


Locations
United Kingdom
King's College Hospital NHS Foundation Trust
London, United Kingdom, SE5 9RS
Sponsors and Collaborators
King's College Hospital NHS Trust
Investigators
Principal Investigator: M.Mansour Ceesay, FRCPath Kings College Hospital
Principal Investigator: Antonio Pagliuca, FRCPath Kings College Hospital
Principal Investigator: Jim Wade, FRCPath Kings College Hospital
Principal Investigator: Melvyn Smith, PhD Kings College Hospital
Principal Investigator: Sujal Desai, FRCR Kings College Hospital
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Mansour Ceesay, Clinical Research Fellow, King's College Hospital NHS Trust
ClinicalTrials.gov Identifier: NCT00816088     History of Changes
Other Study ID Numbers: 08/H0808/154
08HA11
First Posted: December 31, 2008    Key Record Dates
Last Update Posted: December 23, 2014
Last Verified: December 2014

Keywords provided by Mansour Ceesay, King's College Hospital NHS Trust:
chemotherapy
Stem cell transplantation

Additional relevant MeSH terms:
Neutropenia
Aspergillosis
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
 Mycoses
Hyalohyphomycosis
Dermatomycoses
Lung Diseases, Fungal
Skin Diseases, Infectious
Skin Diseases