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

NCT01091493 | Completed Phase 4 DMC

• 1 other identifier: AEPOC-ATB
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 4

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

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

  Six months

Secondary Outcomes (4)

• 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

  Hospitalization day 1 and six months

Study Arms (2)

Non-Antibiotic

NO INTERVENTION

Patients will not receive antibiotics, although the study is double-blind.

Antibiotic

ACTIVE COMPARATOR

Patients will receive in a masked way, moxifloxacin.

Drug: Moxifloxacin

Interventions

Moxifloxacin DRUG

Moxifloxacin 400 mg administered once a day for 5 days

Also known as: Actira

Antibiotic

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundacion Clinic per a la Recerca Biomédica: lead
• Instituto de Salud Carlos III: collaborator

Study Sites (4)

Hospital Miquel Servet

Zaragoza, Aragon, 50009, Spain

Location

Fundacio Clinic Per la Recerca Biomèdica - Hospital Clinic de Barcelona

Barcelona, Catalonia, 08036, Spain

Location

Fundació La Fe- Hospital La Fe

Valencia, Valencia, 46009, Spain

Location

Hospital Clínica Platón

Barcelona, 08006, Spain

Location

Related Publications (3)

• 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.

  PMID: 17630021 BACKGROUND

• 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.

  PMID: 8887592 BACKGROUND

• 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.

  PMID: 11296188 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Moxifloxacin

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Nestor Soler, MD,PhD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Especialista Senior

Study Record Dates

• First Submitted: March 19, 2010
• First Posted: March 24, 2010
• Study Start: July 1, 2010
• Primary Completion: July 5, 2018
• Study Completion: July 5, 2018
• Last Updated: July 6, 2018

Record last verified: 2018-07

Locations

ES (4)