- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00816088
Diagnostic and Management Strategies for Invasive Aspergillosis
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
Descripción general del estudio
Estado
Condiciones
Descripción detallada
The basis of the diagnosis of invasive aspergillosis is usually based on radiological appearances, which are neither sensitive nor specific. The burden of this problem is also not properly documented and there is paucity of prospective data in the literature. Therefore, we want to prospectively collect complete epidemiological data on all our patients. In addition we want to collaborate with radiological, respiratory, and microbiological colleagues to develop a unified approach to diagnosis. In the initial 12-18 months of the study all adult haemato-oncology patients likely to be rendered neutropenic during their treatment will be enrolled. All clinical data will be collected including dose, duration, and side-effects of anti-fungals administered. We will evaluate accepted diagnostic modalities for IA including the determination of optimum cut-offs for galactomannan and B-D-glucan in serum and urine in this cohort. In addition we would investigate the utility of other approaches for the diagnosis of IA such as markers for tissue injury and cytokine profiling.
We would test the urine in parallel with blood for galactomannan and B-D glucan to assess its usefulness with respect to blood.
CT scanning forms an important cornerstone of our diagnostic workup currently. However, there is paucity of data on the natural history and spectrum of CT changes in neutropenic patients with IA. Thus, our aim is to carefully document such changes in our cohort. We aim to rationalise CT imaging in the following way:
Baseline CT:
We aim to perform an initial non-contrast enhanced thin-section continuous volume acquisition thoracic CT study on all the study patients. This will allow us to establish a "baseline" of normality in addition to potentially identifying those patients with pre-existing but indeterminate pulmonary lesions prior to chemotherapy or stem-cell transplantation.
Diagnostic CT:
Neutropaenic patients with febrile episodes that are unresponsive to standard second-line broad-spectrum antibiotics combination (currently meropenem and vancomycin) will be referred for a contrast-enhanced thin section continuous volume CT scan. The purpose of this CT study is primarily to support the clinical suspicion of a diagnosis of IA and to determine its morphological extent. The purpose of the contrast injection is to test the hypothesis that in patients with IA, regions of necrotic lung (in contrast to other "inflammatory" or infective lesions) should not demonstrate any contrast enhancement.
- Follow-up CTs (x2):
In patients with CT features of IA on the Diagnostic CT (see No. 2 above) and who have been commenced on antifungal chemotherapy, two follow-up, low-dose CTs (without iv contrast) will be performed at 10 days and 4 weeks after the diagnostic CT. These CT studies will not only allow us to evaluate the serial changes on CT but also determine the potential relationships between the initial CT features, haematological factors and outcome.
To increase the diagnostic yield, patients who are referred for lung biopsy, will undergo the technique of preoperative "labeling": small indeterminate lung nodules are frequently invisible and impalpable. There is an encouraging literature which indicates that preoperative labeling of lung lesions with a small (0.3-0.5ml) volume of methylene blue which acts a guidance track for the surgeon, may significantly improve the diagnostic yield from surgical (open or video-assisted thoracoscopic) biopsy.
Transplant patients typically would have 2-4 cycles of chemotherapy prior to admission for transplant. As such they have more chance of developing neutropenic infection and IA. Therefore we would perform a baseline bronchoscopy and washing (BAL) to assess the cytokine profile at admission and ensure that no infection is apparent before the initiation of transplant conditioning. A small amount of the BAL sample would be frozen and stored for future studies. Additional bronchoscopy may be done later during admission for both transplant and non-transplant patients if the clinical situation warrants it according to our current clinical practice.
Management strategies would also be assessed prospectively to evaluate the role of both prophylaxis and treatment. We are currently using itraconazole as our prophylactic agent of choice. Serum itraconazole levels will be measured on a weekly basis in all patients to ensure therapeutic levels are achieved.
We will be conducting costing analysis.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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London, Reino Unido, SE5 9RS
- King's College Hospital NHS Foundation Trust
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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neutropenia
Patients undergoing stem cell transplantation or chemotherapy likely to lead to prolonged neutropenia.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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To determine the incidence of IFD using a comprehensive diagnostic approach
Periodo de tiempo: 3 years
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3 years
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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Evaluation of established and experimental diagnostic methods
Periodo de tiempo: 2-3 years
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2-3 years
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Costing analysis
Periodo de tiempo: 2-3 years
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2-3 years
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Establish the prognostic value of CT appearances in patients with IA
Periodo de tiempo: 2-3 years
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2-3 years
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Assessing the value of methylene blue 'tattooing' prior to surgical biopsy
Periodo de tiempo: 2-3 years
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2-3 years
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: M.Mansour Ceesay, FRCPath, Kings College Hospital
- Investigador principal: Antonio Pagliuca, FRCPath, Kings College Hospital
- Investigador principal: Jim Wade, FRCPath, Kings College Hospital
- Investigador principal: Melvyn Smith, PhD, Kings College Hospital
- Investigador principal: Sujal Desai, FRCR, Kings College Hospital
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 08/H0808/154
- 08HA11
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