Chronic Obstructive Lung Disease (COLD) Clinical Trial
Official title:
ANTEAB: a Study of Early Antibiotherapy in the ICU Management of Acute Exacerbations of COPD
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 )
| Status | Completed |
| Enrollment | 520 |
| Est. completion date | October 2006 |
| Est. primary completion date | October 2006 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | Hopital Henri Mondor | Creteil | Val de Marne |
| France | Assistance Publique-Hopitaux de Paris | Paris | Ile de France |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | A 20% reduction of the duration of clinical symptoms of exacerbation is expected | A 20% reduction of the duration of clinical symptoms of exacerbation is expected | during de study | Yes |
| Secondary | The incidence of documented infection, antibiotic use, the proportion of patients having infection with resistant bacteria | The incidence of documented infection, antibiotic use, the proportion of patients having infection with resistant bacteria | during the study | Yes |