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

Chronic Obstructive Pulmonary Disease Clinical Trial

— AEPOC-ATB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01091493
• Other study ID #: AEPOC-ATB
• Status: Completed
• Phase: Phase 4
• Start date: July 2010
• Est. completion date: July 5, 2018

Study information

• Verified date: July 2018
• Source: Fundacion Clinic per a la Recerca Biomédica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: July 5, 2018
• Est. primary completion date: July 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Moxifloxacin
Moxifloxacin 400 mg administered once a day for 5 days

Locations

Country	Name	City	State
Spain	Fundacio Clinic Per la Recerca Biomèdica - Hospital Clinic de Barcelona	Barcelona	Catalonia
Spain	Hospital Clínica Platón	Barcelona
Spain	Fundació La Fe- Hospital La Fe	Valencia	Comunitat Valenciana
Spain	Hospital Miquel Servet	Zaragoza	Aragon

Sponsors (2)

Lead Sponsor	Collaborator
Fundacion Clinic per a la Recerca Biomédica	Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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. Erratum in: Am J Respir Crit Care Med 1997 Jan;155(1):386. — View Citation

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):109-10. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of treatment WITHOUT antibiotics in non-purulent exacerbations of COPD		Six months
Secondary	Efficacy/Safety in treatment on re-hospitalizations at six months.		Six monts
Secondary	In-hospital stay (days)		Six months
Secondary	All cause mortality		One and Six months
Secondary	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