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Early diagnosis of invasive aspergillosis

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)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN85866583
Enrollment
300
Registered
2010-05-19
Start date
2005-06-01
Completion date
Unknown
Last updated
2017-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: National Cancer Research Network

Interventions

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

Sponsors

Barts and The London NHS Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. Inability to give informed consent 2. Patients aged less than 18 years 3. Pre-existing chest disease

Design outcomes

Primary

MeasureTime frame
GM ELISA from serum and BALF, measured within 6 months of the conclusion of the study

Secondary

MeasureTime frame
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

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026