- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01306279
The Infective Pulmonary Exacerbations in Cystic Fibrosis - an Ecological Perspective
Given the treatment burden and excess morbidity and mortality associated with acute infective exacerbations in cystic fibrosis, a clear understanding of the mechanisms involved in the origins of an infective exacerbation and the response to antibiotics is vital to improving long-term outcomes in CF.
This study will examine 3 areas of interest in CF exacerbations.
- Bacterial biodiversity and its clinical significance
- The role of bacteria which are able to rapidly mutate (hypermutators)
- Inter-bacterial communication and its role in infective exacerbations
Study Hypothesis 1
Increased microbiological diversity represents a balanced community of bacteria. The presence of a diverse population of bacteria in CF infections therefore predicts a better outcome for treatment than when a population consists of a small number of more virulent organisms.
Study Hypothesis 2
Pseudomonas aeruginosa hypermutators can mutate much more often than ordinary Pseudomonas aeruginosa bacteria. Hypermutators are likely to grow better when the bacteria are under stress, such as during antibiotic treatment or during an infection. They are, however, weaker organisms because of the multiple mutations they have undergone. Their presence does not relate to clinical outcome but may be associated with the emergence of antibiotic resistance.
Study Hypothesis 3
Some Pseudomonas aeruginosa bacteria communicate with each other by secreting and responding to chemicals known as quorum sensing (QS)molecules. As well as affecting the behaviour of bacteria, these QS molecules can cause inflammation in the lung of CF patients. Selective growth of QS-producing organisms can trigger lung exacerbations in CF. If antibiotics kill this population of bacteria and QS molecule levels drop in the lung, patients recover from infection quickly. Failure to kill these bacteria with antibiotics allow QS molecule levels to remain elevated and patients to have prolonged infections.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
We will sequentially recruit patients attending our CF centre with an infective exacerbation of CF, who are chronically infected with Pseudomonas aeruginosa.
We will record spirometry, blood markers of inflammation, quality of life questionnaires and investigate sputum samples for:
- Routine microbiology
- Bacterial diversity using 16s RNA identification techniques
- Relative abundance of P.aeruginosa hypermutators
- Levels of quorum sensing molecules
These observations will be undertaken before commencing intravenous antibiotic therapy, on days 7, 10 and the last day of antibiotic therapy. Patients will also be reviewed one month after the end of antibiotic therapy where spirometry and a sputum sample will be collected for the above investigations.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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London, Reino Unido, SW3 6NP
- Department of Cystic Fibrosis, NHLI, Imperial College,
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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:
- Confirmed diagnosis of Cystic Fibrosis
- Chronic Pseudomonas aeruginosa
- Symptoms and signs of infective exacerbation
Exclusion Criteria:
- age under 16
- unable to give consent or patients with significant mental health problems
- co-existent active allergic bronchopulmonary aspergillosis requiring a change in steroid or antifungal therapy
- a previous participant in this study
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
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Cystic Fibrosis, infection
Cystic Fibrosis patients with an infective exacerbation
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Margaret Hodson, MD MSc FRCP, Imperial College London
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio
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
- 11/H0713/7
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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