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Clinical Trials/NCT01091493
NCT01091493
Completed
Phase 4

Utility of Antibiotic Treatment in Acute Non-purulent Exacerbations of COPD: a Double Blinded, Randomized, Placebo-controlled Trial of Security and Efficacy

Fundacion Clinic per a la Recerca Biomédica4 sites in 1 country73 target enrollmentJuly 2010

Overview

Phase
Phase 4
Intervention
Moxifloxacin
Conditions
Chronic Obstructive Pulmonary Disease
Sponsor
Fundacion Clinic per a la Recerca Biomédica
Enrollment
73
Locations
4
Primary Endpoint
Efficacy of treatment WITHOUT antibiotics in non-purulent exacerbations of COPD
Status
Completed
Last Updated
7 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
July 2010
End Date
July 5, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Fundacion Clinic per a la Recerca Biomédica
Responsible Party
Principal Investigator
Principal Investigator

Nestor Soler Porcar, MD, PhD

Especialista Senior

Fundacion Clinic per a la Recerca Biomédica

Eligibility 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

Arms & Interventions

Antibiotic

Patients will receive in a masked way, moxifloxacin.

Intervention: Moxifloxacin

Outcomes

Primary Outcomes

Efficacy of treatment WITHOUT antibiotics in non-purulent exacerbations of COPD

Time Frame: Six months

Secondary Outcomes

  • In-hospital stay (days)(Six months)
  • All cause mortality(One and Six months)
  • Efficacy/Safety in treatment on re-hospitalizations at six months.(Six monts)
  • Quality of Life (QoL) measured by the Saint George Respiratory Questionnaire(Hospitalization day 1 and six months)

Study Sites (4)

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