Chronic Obstructive Lung Disease (COLD)
Conditions
Keywords
Chronic Obstructive Lung Disease (COLD), Randomized Clinical Trial, Antibiotics, Acute Exacerbation, Mechanical, Ventilation, Intensive Care, Length of Stay, Mortality
Brief summary
Intensive Care Unit (ICU) admission for acute exacerbation of chronic obstructive lung disease (COLD) is a major cause of morbidity and mortality in such patients. Although bacterial of mortality in such patients. Although bacterial and or viral infections are considered as the major precipitating factor, the antibiotic strategy in this setting is unclear. The absence of overt infection remains controversial, and has not been adequately studied in patients admitted to the ICU. To assess the benefit ( or lack thereof ) of routine early systemic antibiotic therapy in patients with COLD admitted to the ICU. The primary objective of the essay is to evaluate the effectiveness of the precocious antibiotic therapy on the length of the respiratory symptoms with the admitted patients in polyvalent medical intensive care of chronic obstructive lung disease ( COLD )
Detailed description
This is a multicenter, randomised, double-blind controlled trial, comparing amoxicillin-clavulanic acid administered for 7 days to a placebo.
Interventions
DRUGAmoxicillin-clavulanic
Amoxicillin-clavulanic
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients included are those with documented or suspected COLD, exclusive of other bronchial or lung disease, and admitted for acute exacerbation, in the absence of overt sepsis or broncho-pneumonia, and having no other organ.
Exclusion criteria
* Patients recently hospitalised, having received antibiotics since more than 24h, or on long-term steroids will not be included
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A 20% reduction of the duration of clinical symptoms of exacerbation is expected | during de study | A 20% reduction of the duration of clinical symptoms of exacerbation is expected |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of documented infection, antibiotic use, the proportion of patients having infection with resistant bacteria | during the study | The incidence of documented infection, antibiotic use, the proportion of patients having infection with resistant bacteria |
Countries
France
Outcome results
None listed