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

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

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 Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: Moxifloxacin

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08006
    • Hospital Clínica Platón
  • Aragon
    • Zaragoza, Aragon, Spain, 50009
      • Hospital Miquel Servet
  • Catalonia
    • Barcelona, Catalonia, Spain, 08036
      • Fundacio Clinic Per la Recerca Biomèdica - Hospital Clinic de Barcelona
  • Comunitat Valenciana
    • Valencia, Comunitat Valenciana, Spain, 46009
      • Fundació La Fe- Hospital La Fe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Non-Antibiotic; Patients will not receive antibiotics, although the study is double-blind.
Active Comparator: Antibiotic; Patients will receive in a masked way, moxifloxacin.	Drug: Moxifloxacin; Moxifloxacin 400 mg administered once a day for 5 days; Other Names: Actira

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Efficacy of treatment WITHOUT antibiotics in non-purulent exacerbations of COPD	Six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy/Safety in treatment on re-hospitalizations at six months.		Six monts
In-hospital stay (days)		Six months
All cause mortality		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)	Hospitalization day 1 and six months

Collaborators and Investigators

• Sponsor: Fundacion Clinic per a la Recerca Biomédica
• Collaborators: Instituto de Salud Carlos III
• Investigators: Principal Investigator: Nestor Soler, MD,PhD, Hospital Clinic of Barcelona

Publications and helpful links

General Publications

• Connors AF Jr, Dawson NV, Thomas C, Harrell FE Jr, Desbiens N, Fulkerson WJ, Kussin P, Bellamy P, Goldman L, Knaus WA. Outcomes following acute exacerbation of severe chronic obstructive lung disease. The SUPPORT investigators (Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments). Am J Respir Crit Care Med. 1996 Oct;154(4 Pt 1):959-67. doi: 10.1164/ajrccm.154.4.8887592. Erratum In: Am J Respir Crit Care Med 1997 Jan;155(1):386.
• Murray CJ, Lopez AD, Black R, Mathers CD, Shibuya K, Ezzati M, Salomon JA, Michaud CM, Walker N, Vos T. Global burden of disease 2005: call for collaborators. Lancet. 2007 Jul 14;370(9582):109-110. doi: 10.1016/S0140-6736(07)61064-2. No abstract available.
• Snow V, Lascher S, Mottur-Pilson C; Joint Expert Panel on COPD of the American College of Chest Physicians and the American College of Physicians-Amercian Society of Internal Medicine. The evidence base for management of acute exacerbations of COPD: clinical practice guideline, part 1. Chest. 2001 Apr;119(4):1185-9. doi: 10.1378/chest.119.4.1185. No abstract available.

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): July 5, 2018
• Study Completion (Actual): July 5, 2018

Study Registration Dates

• First Submitted: March 19, 2010
• First Submitted That Met QC Criteria: March 23, 2010
• First Posted (Estimate): March 24, 2010

Study Record Updates

• Last Update Posted (Actual): July 6, 2018
• Last Update Submitted That Met QC Criteria: July 5, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: COPD
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Moxifloxacin
• Other Study ID Numbers: AEPOC-ATB