Antibiotic or Not in Non-purulent Exacerbations of COPD: a Trial of Security and Efficacy
Status:
Completed
Trial end date:
2018-07-05
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 4
Details
Lead Sponsor:
Fundacion Clinic per a la Recerca Biomédica
Collaborator:
Instituto de Salud Carlos III
Treatments:
Anti-Bacterial Agents Antibiotics, Antitubercular Moxifloxacin Norgestimate, ethinyl estradiol drug combination