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This study compared the clinical efficacy and safety of azithromycin with that of amoxicillin-clavulanic acid, in patients between the ages of 35 and 75 years, presenting with an exacerbation of chronic bronchitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 2 | Active Comparator |
| |
| Group 1 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amoxicillin/clavulinic acid | Drug | amoxicillin/clavulinic acid 500 mg/62.5 mg tablet; take 2 tablets by mouth twice daily (BID) for 10 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess clinical efficacy (clinical recovery or clinical failure) | Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of exacerbations | Day 30 to Day 90 | |
| Bacteriological monitoring (a descriptive analysis of streptococci in the bacterial flora and their sensitivity to antibiotics at the different collections of sputum) | continuous |
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Inclusion Criteria:
Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Anzin | 59410 | France | |||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Azithromycin | Drug | Azithromycin 250 mg tablet; take 2 tablets by mouth on the first day, then 1 tablet by mouth from Days 2 to 5 |
|
| Avignon |
| 84 000 |
| France |
| Pfizer Investigational Site | Avignon | 84000 | France |
| Pfizer Investigational Site | Dijon | 21000 | France |
| Pfizer Investigational Site | Escaudain | 59 124 | France |
| Pfizer Investigational Site | Équeurdreville-Hainneville | 50120 | France |
| Pfizer Investigational Site | Le Grand-Quevilly | 76120 | France |
| Pfizer Investigational Site | Les Lilas | 93 260 | France |
| Pfizer Investigational Site | Lyon | 69001 | France |
| Pfizer Investigational Site | Mantes-la-Jolie | 78200 | France |
| Pfizer Investigational Site | Maromme | 76150 | France |
| Pfizer Investigational Site | Marseille | 13 008 | France |
| Pfizer Investigational Site | Maubeuge | 59600 | France |
| Pfizer Investigational Site | Mont-Saint-Martin | 54350 | France |
| Pfizer Investigational Site | Nancy | 54000 | France |
| Pfizer Investigational Site | Paris | 75 016 | France |
| Pfizer Investigational Site | Paris | 75012 | France |
| Pfizer Investigational Site | Paris | 75017 | France |
| Pfizer Investigational Site | Paris | 75020 | France |
| Pfizer Investigational Site | Saint-Aulaire | 19 130 | France |
| Pfizer Investigational Site | Savigny | 91600 | France |
| Pfizer Investigational Site | Soissons | 02 200 | France |
| Pfizer Investigational Site | Tourcoing | 59200 | France |
| Pfizer Investigational Site | Tulette | 26 790 | France |
| Pfizer Investigational Site | Valenton | 94460 | France |
| Pfizer Investigational Site | VAUX S/ Seine | 78740 | France |
| Pfizer Investigational Site | Villejuif | 94800 | France |
| Pfizer Investigational Site | Vincennes | 94300 | France |
| Pfizer Investigational Site | Vitry | 94 400 | France |
| Pfizer Investigational Site | Wattrelos | 59150 | France |
| Pfizer Investigational Site | Yerres | 91330 | France |
| ID | Term |
|---|---|
| D029481 | Bronchitis, Chronic |
| ID | Term |
|---|---|
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000658 | Amoxicillin |
| D017963 | Azithromycin |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
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