Effectiveness of Antibiotic Therapy for Exacerbations of Chronic Obstructive Pulmonary Disease
Information source: Catalan Society of Family Medicine
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Obstructive Pulmonary Disease
Intervention: Placebo (Drug); Amoxicillin and clavulanic acid (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Catalan Society of Family Medicine Official(s) and/or principal investigator(s):
Carl Llor, Doctor, Principal Investigator, Affiliation: Catalan Society of Family Medicine
Marc Miravitlles, Doctor, Study Director, Affiliation: Hospital Clinic
Ana Moragas, Family doc., Study Director, Affiliation: Catalan Society of Family Medicine
Overall contact:
Ana Moragas, Family doc., Phone: +34 600072170, Email: amoragasm@medynet.com
Summary
The purpose of this study is to determine the effectiveness of antibiotic therapy for
patients with acute exacerbations of mild-to-moderate chronic obstructive pulmonary disease.
Clinical Details
Official title: Situations That do Not Require Antibiotics for Acute Exacerbations of Mild-to-Moderate Chronic Obstructive Pulmonary Disease
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Cure rate
Secondary outcome: Number of days till the next exacerbation
Detailed description:
Antibiotics are usually prescribed for acute exacerbations of chronic obstructive pulmonary
disease (COPD) even though their benefit in mild-to-moderate COPD is not demonstrated. The
aim of this study is to assess the effectiveness of antibiotic therapy for exacerbations of
COPD, what clinical variables are associated with an improved clinical response with
antibiotic therapy with respect to placebo and to identify which patients might recover from
an acute exacerbation without antibiotic therapy. Methodology: prospective, randomised,
double blind, placebo-controlled clinical trial, in which exacerbations (at least one
criterion present: increase of dyspnoea, increase of sputum production and/or increase of
purulence) of patients older than 40 yr., smokers or ex-smokers of more than 10 pack-years,
with COPD and FEV1 greater than 50%, diagnosed by spirometry and a predicted ratio
FEV1/FVC<0. 7%. Exclusion criteria: severe COPD (FEV1<50%), active neoplasm, tracheotomy,
pneumonia, hospitalization criteria, patients previously being on antibiotics,
immunodepressed, history of hypersensitivity to beta-lactams or intolerance to clavulanate,
enrollment in other clinical trials, patients who refuse to take part in this study, and
patients who have not had a spirometry test for the past two years. Sample size: 677
patients. Interventions: first visit: the patient will be given details of the clinical trial
and will be asked to sign informed consent; other data: sputum color, chest X-ray ordered to
rule out pneumonia, C-reactive protein levels, and peak flow measurement. The patient will be
randomised to receive amoxicillin plus clavulanate or placebo and will be scheduled to return
for a 2nd follow-up visit after 3 or 4 days to assess the clinical response and peak flow
measurements and to rule out any worsening of the condition. Third visit: scheduled after
9-11 days to assess the clinical response, drug-compliance and peak flow measurement. Fourth
visit after 15-20 days for clinical assessment and to observe whether any relapses have
occurred. Date of the following exacerbation will be recorded.
Eligibility
Minimum age: 40 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Acute exacerbations (at least one criterion present: increase of dyspnoea, increase of
sputum production and/or increase of purulence) of
- patients older than 40 years old,
- smokers or ex-smokers of more than 10 pack-years,
- with COPD and FEV1 greater than 50%, diagnosed by spirometry and a predicted ratio
FEV1/FVC<0. 7%.
Exclusion Criteria:
- Severe COPD (FEV1<50%)
- Pneumonia
- Active neoplasm
- Tracheotomy
- Criteria for hospitalisation
- Patients previously being on antibiotics
- Immunodepressed patients
- History of hypersensitivity to beta-lactams or intolerance to clavulanate
- Enrollment in other clinical trials
- Patients who refuse to take part in this study
- Patients who have not had a spirometry test for the past two years
Locations and Contacts
Ana Moragas, Family doc., Phone: +34 600072170, Email: amoragasm@medynet.com
Primary Healthcare Center Valls Urbà, Valls, CAtalonia 43600, Spain; Not yet recruiting
Carolina Bayona, Family doc., Principal Investigator
Dolors Llovet, Family doc., Sub-Investigator
Primary Healthcare Centre Jaume I, Tarragona, Catalonia 43005, Spain; Recruiting
Ana Moragas, Family doc., Phone: +34600072170, Email: amoragasm@meditex.es
Silvia Hernandez, Doctor, Sub-Investigator
Yvonne Fernandez, Family doc., Sub-Investigator
Aitor Alfaro, Family doc., Sub-Investigator
Manel Perez, Family doc., Sub-Investigator
Carl Llor, Doctor, Principal Investigator
Primary Healthcare Center La Marina, Barcelona, Catalonia 08038, Spain; Not yet recruiting
Josep Maria Cots, Family doc., Principal Investigator
José Miguel Baena, Family doc., Sub-Investigator
Primary Healthcare Centre Breda-Hostalric, Hostalric, Catalonia 17450, Spain; Not yet recruiting
José Paredes, Family doc., Principal Investigator
Primary Healthcare Center Montilivi, Girona, Catalonia 17003, Spain; Not yet recruiting
Carlos Cerezo, Family doc., Principal Investigator
Primary Healthcare Center Reus-3, Reus, Catalonia 43203, Spain; Not yet recruiting
Ramon Descarrega, Family doc., Principal Investigator
Manuel Prieto, Family doc., Sub-Investigator
Primary Healthcare Center Figueres, Figueres, Catalonia 17600, Spain; Not yet recruiting
Zoila Bastardo, Family doc., Principal Investigator
Primary Healthcare Centre Olot, Olot, Catalonia 17800, Spain; Not yet recruiting
Jacint Caula, Family doc., Principal Investigator
Primary Healthcare Center Girona-4, Girona, Catalonia 17007, Spain; Not yet recruiting
Anna Picas, Family doc., Principal Investigator
Primary Healthcare Center Lleida, Lleida, Catalonia 25001, Spain; Not yet recruiting
Jesus Pujol, Family doc., Principal Investigator
Primary Healthcare Center Les Muralles, Tarragona, Catalonia 43003, Spain; Not yet recruiting
Elena Taverna, Family doc., Principal Investigator
Ramon Monegal, Family doc., Sub-Investigator
Hospital Clínic, Barcelona, Catalonia 08036, Spain; Not yet recruiting
Marc Miravitlles, Pneumologist, Principal Investigator
Additional Information
Starting date: October 2007
Ending date: March 2010
Last updated: May 27, 2008
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