Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 )
This is a multicenter, randomised, double-blind controlled trial, comparing amoxicillin-clavulanic acid administered for 7 days to a placebo.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Amoxicillin-clavulanic |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amoxicillin-clavulanic | Drug | Amoxicillin-clavulanic |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christian BRUN-BUISSON, Pr,MD,PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Henri Mondor | Créteil | Val de Marne | 94000 | France | ||
| Assistance Publique-Hopitaux de Paris |
Not provided
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
Not provided
Not provided
| ID | Term |
|---|---|
| D019980 | Amoxicillin-Potassium Clavulanate Combination |
| ID | Term |
|---|---|
| D019818 | Clavulanic Acid |
| D002969 | Clavulanic Acids |
| D047090 | beta-Lactams |
| D007769 | Lactams |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Paris |
| Île-de-France Region |
| 75000 |
| France |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012120 | Respiration Disorders |
| D000577 |
| Amides |
| D009930 | Organic Chemicals |
| D000658 | Amoxicillin |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |