Antibiotic or Not in Non-purulent Exacerbations of COPD: a Trial of Security and Efficacy (AEPOC-ATB)
Utility of Antibiotic Treatment in Acute Non-purulent Exacerbations of COPD: a Double Blinded, Randomized, Placebo-controlled Trial of Security and Efficacy
COPD is one of the most important causes of morbidity and mortality and supposes a sanitary problem in Europe and USA. Patients with COPD usually have 1-2 episodes of acute exacerbation of COPD (AECOPD) per year, being these the principal causes of of hospitalizations, respiratory problems and medical visits. After an episode of AECOPD, the majority of patients develop a transitory (or permanent) worsening in their quality of life and 50% of them will require a new hospitalization. Globally, a 75%& of the exacerbations might be associated with a respiratory tract infection, and among them, 50% might be related to bacteria and in 45% an evidence of viral infection could be documented. Even though the antibiotic treatment might not be useful for a majority of patients with AECOPD, is generalized its use(almost an 85% in some series) in hospitalized patients. The non-controlled use of antibiotics in AECOPD results in a very expensive disease and raises the rate of resistance of bacteria. The available literature have shown that there's a relation between exacerbations and infections, based on sputum samples.
In summary, is well known that at least a 50% of the episodes of AECOPD might be associated with pathogenic bacteria in the lower respiratory tract. Prescription of antibiotics is wide and generalized in hospitalized patients. Clinical trials have shown correlation between AECOPD with sputum purulence (which correlates with presence of bacteria), however they've not included NON-purulent AECOPD, even though they're a significative group of patients hospitalized by this cause too. It's necessary to evaluate the efficacy nor the security of antibiotic treatment in this group of patients in a well designed trial.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 4
Contactos y Ubicaciones
Ubicaciones de estudio
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Barcelona, España, 08006
- Hospital Clínica Platón
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Aragon
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Zaragoza, Aragon, España, 50009
- Hospital Miquel Servet
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Catalonia
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Barcelona, Catalonia, España, 08036
- Fundacio Clinic Per la Recerca Biomèdica - Hospital Clinic de Barcelona
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Comunitat Valenciana
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Valencia, Comunitat Valenciana, España, 46009
- Fundació La Fe- Hospital La Fe
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- COPD diagnosis according to GOLD guidelines
- Hospitalization for any acute exacerbation of chronic obstructive pulmonary disease
- Failure of outpatient treatment
- Increasing of dyspnea in the last days
- Comorbidity that causes detriment of respiratory function
Exclusion Criteria:
- Life expectancy of less than 6 months
- Mechanical Ventilation
- Cardiovascular condition that causes exacerbation
- Immunosuppression
- Pulmonary infiltrates that suggest pneumonia
- Antibiotic treatment in the last month
- Pregnancy
- ECG with a large QT segment
- Hypokalemia
- Hepatic failure or renal failure
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Sin intervención: Non-Antibiotic
Patients will not receive antibiotics, although the study is double-blind.
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Comparador activo: Antibiotic
Patients will receive in a masked way, moxifloxacin.
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Moxifloxacin 400 mg administered once a day for 5 days
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Efficacy of treatment WITHOUT antibiotics in non-purulent exacerbations of COPD
Periodo de tiempo: Six months
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Six months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Efficacy/Safety in treatment on re-hospitalizations at six months.
Periodo de tiempo: Six monts
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Six monts
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In-hospital stay (days)
Periodo de tiempo: Six months
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Six months
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All cause mortality
Periodo de tiempo: One and Six months
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One and Six months
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Quality of Life (QoL) measured by the Saint George Respiratory Questionnaire
Periodo de tiempo: Hospitalization day 1 and six months
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This item will be measured by the application of the Saint George Respiratory Questionnaire (SGRQ)
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Hospitalization day 1 and six months
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Nestor Soler, MD,PhD, Hospital Clinic of Barcelona
Publicaciones y enlaces útiles
Publicaciones Generales
- Connors AF Jr, Dawson NV, Thomas C, Harrell FE Jr, Desbiens N, Fulkerson WJ, Kussin P, Bellamy P, Goldman L, Knaus WA. Outcomes following acute exacerbation of severe chronic obstructive lung disease. The SUPPORT investigators (Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments). Am J Respir Crit Care Med. 1996 Oct;154(4 Pt 1):959-67. doi: 10.1164/ajrccm.154.4.8887592. Erratum In: Am J Respir Crit Care Med 1997 Jan;155(1):386.
- Murray CJ, Lopez AD, Black R, Mathers CD, Shibuya K, Ezzati M, Salomon JA, Michaud CM, Walker N, Vos T. Global burden of disease 2005: call for collaborators. Lancet. 2007 Jul 14;370(9582):109-110. doi: 10.1016/S0140-6736(07)61064-2. No abstract available.
- Snow V, Lascher S, Mottur-Pilson C; Joint Expert Panel on COPD of the American College of Chest Physicians and the American College of Physicians-Amercian Society of Internal Medicine. The evidence base for management of acute exacerbations of COPD: clinical practice guideline, part 1. Chest. 2001 Apr;119(4):1185-9. doi: 10.1378/chest.119.4.1185. No abstract available.
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 (Actual)
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
- Enfermedades de las vías respiratorias
- Enfermedades pulmonares
- Enfermedades Pulmonares Obstructivas
- Enfermedad Pulmonar Obstructiva Crónica
- Mecanismos moleculares de acción farmacológica
- Agentes antiinfecciosos
- Inhibidores de enzimas
- Agentes antineoplásicos
- Inhibidores de la topoisomerasa II
- Inhibidores de la topoisomerasa
- Agentes antibacterianos
- Moxifloxacino
Otros números de identificación del estudio
- AEPOC-ATB
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