Diagnostic and Management Strategies for Invasive Aspergillosis

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Mansour Ceesay, King's College Hospital NHS Trust

ClinicalTrials.gov Identifier:

NCT00816088

First received: December 30, 2008

Last updated: December 22, 2014

Last verified: December 2014

History of Changes

Purpose

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
Invasive Aspergillosis Neutropenia


Study Type:	Observational
Study Design:	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

Resource links provided by NLM:

Genetics Home Reference related topics: cyclic neutropenia

MedlinePlus related topics: Aspergillosis

Genetic and Rare Diseases Information Center resources: Granulocytopenia Aspergillosis

U.S. FDA Resources

Further study details as provided by King's College Hospital NHS Trust:

Primary Outcome Measures:

To determine the incidence of IFD using a comprehensive diagnostic approach [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evaluation of established and experimental diagnostic methods [ Time Frame: 2-3 years ] [ Designated as safety issue: No ]
Costing analysis [ Time Frame: 2-3 years ] [ Designated as safety issue: No ]
Establish the prognostic value of CT appearances in patients with IA [ Time Frame: 2-3 years ] [ Designated as safety issue: No ]
Assessing the value of methylene blue 'tattooing' prior to surgical biopsy [ Time Frame: 2-3 years ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Seum, Whole blood, urine, broncho-alveolar lavage, tissue


Enrollment:	203
Study Start Date:	December 2008
Study Completion Date:	December 2011
Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

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

Show Detailed Description

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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

Buckner SL, Ceesay MM, Pagliuca A, Morgan PE, Flanagan RJ. Measurement of posaconazole, itraconazole, and hydroxyitraconazole in plasma/serum by high-performance liquid chromatography with fluorescence detection. Ther Drug Monit. 2011 Dec;33(6):735-41. doi: 10.1097/FTD.0b013e3182381bb1.


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
Study First Received:	December 30, 2008
Last Updated:	December 22, 2014
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by King's College Hospital NHS Trust:


chemotherapy Stem cell transplantation

Additional relevant MeSH terms:


Neutropenia Aspergillosis Agranulocytosis Leukopenia Leukocyte Disorders Hematologic Diseases	Hyalohyphomycosis Dermatomycoses Skin Diseases, Infectious Infection Mycoses Skin Diseases

ClinicalTrials.gov processed this record on September 23, 2016

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