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| NB: The information displayed below does not replace the protocol. The latest protocol version should always be consulted before making clinical decisions. |
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Early Diagnosis of Invasive Aspergillosis
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Early diagnosis of invasive aspergillosis in a high risk group of patients using serum and bronchoalveolar lavage fluid, real time PCR and Galactomannan ELISA
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Topic
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Cancer
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Portfolio Eligibility
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UKCRN adopted, non-commercial study
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ISRCTN
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85866583
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EudraCT
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MREC N° |
05/Q0603/68
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UKCRN ID |
2242
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WHO ID
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Research Summary
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Invasive fungal infections in immunocompromised patients carry a high mortality and diagnosis can be very dificult. Treatment is often commenced empirially in the context of a febrile illness and neutropenia unresponsive to antibiotics. Antifungal agents are expensive and toxic for this hospital-acquired infection. Improvement in diagnostic techniques would allow genuine fungal infection to be treated early and unnesssary harmful therapy to be withheld. The aim of the study is to determine characteristics for two diagnostics tests in invasive aspergillosis (IA) in patients at high risk with neutropenia following intensive chemotherapy or allogenic bone marrow transpant. This will include sensitivity and specificity and the calculation of positive and negative predictive values for our population. This is a single centre prospective study, which requires twice weekly blood samples from inpatients fulfilling the inclusion criteria in addition to collection of exhaled breath condensate, which will be measured from the onset of neutropenia at weekly intervals until resolution of fever or recovery of the neutrophil count. This is a novel application for a well recognised, well tolerated, non-invasive technique. As such, data from EBC will be analysed after the first 10 patients to assess its utility. In patients with abnormal chest radiology, bronchoscopy and bronchoalveolar lavage (BAC) 72 hours after onset of fever unresponsive to routine antibiotics will be carried out as part of routine management. A part of the sample obtained will also be used in this study, where applicable. Simple clinical information will be collected during their admission. Recovery of the neutrophil count or from infection will signify the end of the study period. Each course of chemotherapy will count as a separate episode therefore patients may be included in the trial more than once. Consent will be sought separately for each inclusion. This study requires 400 patient episodes and should be
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Study Type |
Both
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Design Type |
Diagnosis, Validn of investig/therapeutic procs
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Disease(s) |
Miscellaneous
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Phase |
N/A
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Current Status
| Open |
| Closure Date | 01/09/2008 |
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Sample Size
| 300 |
| Accrual to Date |
 | 81% |
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Geographical Scope
| Single Centre |
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Lead Country
| Unknown (also active in England) |
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Open to new sites
| No |
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Main Inclusion Criteria
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•Informed consent.
•Patients with AML, MDS and ALL undergoing intensive chemotherapy (predicted neutropenia of <0.5 x 109/L for > 10 days) and/or receiving high dose steroids
•Patients undergoing allogeneic haematopoietic stem cell transplantation (HSCT).
•Patients requiring high dose steroids for graft versus host disease post HSCT.
•Patients with a history of probable or proven invasive aspergillosis and having chemotherapy, regardless of their underlying haematological malignancy.
•Age greater than 18.
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Main Exclusion Criteria
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•Inability to give informed consent.
•Patients aged less than 18
•Pre-existing chest disease
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Chief Investigator(s)
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| Dr Samir G Agrawal |
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Further details, please contact
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Dr Samir G Agrawal
Barts and The London Trust
Department of Haematology
St. Bartholomews Hospital
West Smithfield
London
EC1A 7BE
UNITED KINGDOM
s.g.agrawal@qmul.ac.uk
| Mrs Denise Andrews
North East London Cancer Research Network
Ground Floor
Pathology Block
St. Bartholomews Hospital
West Smithfield
London
EC1A 7BE
UNITED KINGDOM
Tel: 0207 601 8815
denise.andrews@bartsandthelondon.nhs.uk
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Funder(s) |
Pfizer
Gilead Sciences Inc
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Sponsor(s) |
Barts and The London Trust
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