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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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

Criteria

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