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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
73
Moxifloxacin 400 mg administered once a day for 5 days
Hospital Miquel Servet
Zaragoza, Aragon, Spain
Fundacio Clinic Per la Recerca Biomèdica - Hospital Clinic de Barcelona
Barcelona, Catalonia, Spain
Fundació La Fe- Hospital La Fe
Valencia, Valencia, Spain
Hospital Clínica Platón
Barcelona, Spain
Efficacy of treatment WITHOUT antibiotics in non-purulent exacerbations of COPD
Time frame: Six months
Efficacy/Safety in treatment on re-hospitalizations at six months.
Time frame: Six monts
In-hospital stay (days)
Time frame: Six months
All cause mortality
Time frame: One and Six months
Quality of Life (QoL) measured by the Saint George Respiratory Questionnaire
This item will be measured by the application of the Saint George Respiratory Questionnaire (SGRQ)
Time frame: Hospitalization day 1 and six months
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