Antibiotic or Not in Non-purulent Exacerbations of COPD: a Trial of Security and Efficacy (AEPOC-ATB)
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Moxifloxacin
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD
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
Sites / Locations
- Hospital Miquel Servet
- Fundacio Clinic Per la Recerca Biomèdica - Hospital Clinic de Barcelona
- Fundació La Fe- Hospital La Fe
- Hospital Clínica Platón
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Non-Antibiotic
Antibiotic
Arm Description
Patients will not receive antibiotics, although the study is double-blind.
Patients will receive in a masked way, moxifloxacin.
Outcomes
Primary Outcome Measures
Efficacy of treatment WITHOUT antibiotics in non-purulent exacerbations of COPD
Secondary Outcome Measures
Efficacy/Safety in treatment on re-hospitalizations at six months.
In-hospital stay (days)
All cause mortality
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)
Full Information
NCT ID
NCT01091493
First Posted
March 19, 2010
Last Updated
July 5, 2018
Sponsor
Fundacion Clinic per a la Recerca Biomédica
Collaborators
Instituto de Salud Carlos III
1. Study Identification
Unique Protocol Identification Number
NCT01091493
Brief Title
Antibiotic or Not in Non-purulent Exacerbations of COPD: a Trial of Security and Efficacy
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
July 5, 2018 (Actual)
Study Completion Date
July 5, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundacion Clinic per a la Recerca Biomédica
Collaborators
Instituto de Salud Carlos III
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
73 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Non-Antibiotic
Arm Type
No Intervention
Arm Description
Patients will not receive antibiotics, although the study is double-blind.
Arm Title
Antibiotic
Arm Type
Active Comparator
Arm Description
Patients will receive in a masked way, moxifloxacin.
Intervention Type
Drug
Intervention Name(s)
Moxifloxacin
Other Intervention Name(s)
Actira
Intervention Description
Moxifloxacin 400 mg administered once a day for 5 days
Primary Outcome Measure Information:
Title
Efficacy of treatment WITHOUT antibiotics in non-purulent exacerbations of COPD
Time Frame
Six months
Secondary Outcome Measure Information:
Title
Efficacy/Safety in treatment on re-hospitalizations at six months.
Time Frame
Six monts
Title
In-hospital stay (days)
Time Frame
Six months
Title
All cause mortality
Time Frame
One and Six months
Title
Quality of Life (QoL) measured by the Saint George Respiratory Questionnaire
Description
This item will be measured by the application of the Saint George Respiratory Questionnaire (SGRQ)
Time Frame
Hospitalization day 1 and six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nestor Soler, MD,PhD
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Miquel Servet
City
Zaragoza
State/Province
Aragon
ZIP/Postal Code
50009
Country
Spain
Facility Name
Fundacio Clinic Per la Recerca Biomèdica - Hospital Clinic de Barcelona
City
Barcelona
State/Province
Catalonia
ZIP/Postal Code
08036
Country
Spain
Facility Name
Fundació La Fe- Hospital La Fe
City
Valencia
State/Province
Comunitat Valenciana
ZIP/Postal Code
46009
Country
Spain
Facility Name
Hospital Clínica Platón
City
Barcelona
ZIP/Postal Code
08006
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
17630021
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):109-110. doi: 10.1016/S0140-6736(07)61064-2. No abstract available.
Results Reference
background
PubMed Identifier
8887592
Citation
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.
Results Reference
background
PubMed Identifier
11296188
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. doi: 10.1378/chest.119.4.1185. No abstract available.
Results Reference
background
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Antibiotic or Not in Non-purulent Exacerbations of COPD: a Trial of Security and Efficacy
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