Early diagnosis of invasive aspergillosis

ISRCTN	ISRCTN85866583
DOI	https://doi.org/10.1186/ISRCTN85866583
Protocol serial number	2242
Sponsor	Barts and The London NHS Trust (UK)
Funders	Gilead Sciences Inc (USA), Pfizer (UK)

Submission date: 19/05/2010
Registration date: 19/05/2010
Last edited: 14/03/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

http://www.cancerhelp.org.uk/trials/a-trial-looking-at-2-new-tests-to-diagnose-a-fungal-infection

Contact information

Mrs Denise Andrews
Scientific

Ground Floor, Pathology Block
St. Bartholomews Hospital
West Smithfield
London
EC1A 7BE
United Kingdom

Study information

Primary study design	Observational
Study design	Single centre observational diagnosis and validation of investigative/therapeutic process study
Secondary study design	Cohort study
Study type	Participant information sheet
Scientific title	Early diagnosis of invasive aspergillosis in a high risk group of patients using serum and bronchoalveolar lavage fluid, real time polymerase chain reaction (PCR) and galactomannan enzyme-linked immunosorbent assay (ELISA)
Study objectives	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.
Ethics approval(s)	East London and the City Research Ethics Board, 01/06/2005, ref: 05/Q0603/68
Health condition(s) or problem(s) studied	Topic: National Cancer Research Network; Subtopic: Lung Cancer; Disease: Miscellaneous
Intervention	Study interventions will begin prior to the start of chemo/immunosuppression and continue until recovery of the neutrophil count to greater than 1.0 x 10^9/L. If fungal infection occurs, then testing should continue until discharge. Samples will be analysed in batches. A febrile episode is defined as any of the following: 1. Temperature greater than 38°C for more than 4 hours 2. Temperature greater than 38°C on two occassions greater than 4 hours apart within a 24 hour period 3. Temp greater than 38.5°C on one occassion PCR: PCR for fungal DNA will be performed twice weekly.
Intervention type	Other
Primary outcome measure(s)	GM ELISA from serum and BALF, measured within 6 months of the conclusion of the study
Key secondary outcome measure(s)	Measured within 6 months of the conclusion of the study: 1. To establish cut off points to rule IA in or out 2. GM Elisa in prognosis 3. Inflamatory marker and cytokine profil in EBC 4. Non-invasive EBC in IA 5. PCR for Aspergillus 6. PCR for Aspergillus from blood and BALF 7. Repeated measures over time or a combination of markers 8. Role of BAL
Completion date	31/07/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	300
Key inclusion criteria	1. Informed consent 2. Patients with acute myeloid leukemia (AML), myelodysplastic syndromes (MDS) and acute lymphoblastic leukemia (ALL) undergoing intensive chemotherapy (predicted neutropenia of less than 0.5 x 10^9/L for greater than 10 days) and/or receiving high dose steroids 3. Patients undergoing allogeneic haematopoietic stem cell transplantation (HSCT) 4. Patients requiring high dose steroids for graft versus host disease post HSCT 5. Patients with a history of probable or proven invasive aspergillosis and having chemotherapy, regardless of their underlying haematological malignancy 6. Aged greater than 18 years, either sex
Key exclusion criteria	1. Inability to give informed consent 2. Patients aged less than 18 years 3. Pre-existing chest disease
Date of first enrolment	01/06/2005
Date of final enrolment	31/07/2011

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Ground Floor, Pathology Block

London
EC1A 7BE
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

14/03/2017: No publications found in PubMed, verifying study status with principal investigator
17/02/2011: The anticipated end date for this trial has been updated from 01/09/2008 to 31/07/2011