Antibiotic or Not in Non-purulent Exacerbations of COPD: a Trial of Security and Efficacy (AEPOC-ATB)

Fundacion Clinic per a la Recerca Biomédica

Status and phase

Completed

Phase 4

Conditions

Chronic Obstructive Pulmonary Disease

Treatments

Drug: Moxifloxacin

Study type

Interventional

Funder types

Other

Identifiers

NCT01091493

AEPOC-ATB

Details and patient eligibility

About

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.

Enrollment

73 patients

Sex

All

Ages

40 to 90 years old

Volunteers

No Healthy Volunteers

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