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The primary objective was to compare the bacteriological efficacy at Day 10 of azithromycin pediatric suspension (20 mg/kg/day once daily for 3 consecutive days) versus amoxicillin pediatric suspension (50 mg/kg/day in 2 doses for 6 consecutive days) in children aged 3-15 years with Group A streptococcal acute pharyngitis/tonsillitis. Secondary objectives were assessments of bacteriological efficacy at Day 30 and clinical efficacy at Day 10 and Day 30.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zithromax | Drug | azithromycin (Zithromax) pediatric suspension formulation (200 mg/5 ml) administered as an oral suspension at a dose of 20 mg/kg once a day (maximal dose 500 mg/day) for 3 consecutive days |
| Measure | Description | Time Frame |
|---|---|---|
| Bacteriologic success (Eradication: elimination of the original GABS; or Colonization: elimination of the original GABS but isolation of another stain of GABS) or failure (Persistence: presence of original GABS on repeated culture samples) rate | Day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Bacteriological success or failure rate | Day 30 | |
| Clinical success (resolution of signs and symptoms, or sufficient improvement; no additional antibacterial therapy indicated) or failure (insufficient improvement or worsening of signs and symptoms; additional antibacterial therapy indicated) rate |
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Inclusion Criteria:
Outpatients with an acute pharyngitis erythematous or erythematopultaceous with modification of pharynx aspect and fever of ≥38° C, and patients either with or without spontaneous pharyngeal pain or upon swallowing and enlargement of the cervical lymph node (mandibular area) were eligible for inclusion. All subjects should have had a positive rapid strep test and a positive culture for Group A beta-hemolytic streptococcus.
Exclusion Criteria:
Patients with pseudomembranous, vesicular, ulcerous or ulceronecrotic pharyngitis were excluded.
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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 | Ancenis | 44150 | 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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| Clamoxyl | Drug | Amoxicillin (Clamoxyl) pediatric formulation (500 mg/5 ml) administered as an oral suspension at a dose of 25 mg/kg twice daily (maximal dose 2 g/day) for 6 consecutive days |
|
| Day 10 |
| Clinical success or failure rate | Day 30 |
| Serious and non-serious adverse events (AEs) rates | continuous |
| Rate of poststreptococcal complications and new disease occurrence since Day 10 | Day 30 |
| Asnières-sur-Seine |
| 92600 |
| France |
| Pfizer Investigational Site | Auch | 32000 | France |
| Pfizer Investigational Site | Boulogne | 92100 | France |
| Pfizer Investigational Site | Brest | 29200 | France |
| Pfizer Investigational Site | Brivé | 19100 | France |
| Pfizer Investigational Site | Cannes LA BOCA | 06150 | France |
| Pfizer Investigational Site | Chambéry | 73000 | France |
| Pfizer Investigational Site | Champigny-sur-Marne | 94500 | France |
| Pfizer Investigational Site | Châlons-en-Champagne | 51000 | France |
| Pfizer Investigational Site | Combs-la-Ville | 77380 | France |
| Pfizer Investigational Site | Dijon | 21000 | France |
| Pfizer Investigational Site | Draguignan | 33170 | France |
| Pfizer Investigational Site | Draguignan | 83300 | France |
| Pfizer Investigational Site | Essey-lès-Nancy | 54270 | France |
| Pfizer Investigational Site | Lagny | 77400 | France |
| Pfizer Investigational Site | Les Sables-d'Olonne | 85100 | France |
| Pfizer Investigational Site | Les Ulis | 91940 | France |
| Pfizer Investigational Site | Levallois-Perret | 92300 | France |
| Pfizer Investigational Site | Marseille | 13006 | France |
| Pfizer Investigational Site | Marseille | 13013 | France |
| Pfizer Investigational Site | Marseille | 13014 | France |
| Pfizer Investigational Site | Massy | 91300 | France |
| Pfizer Investigational Site | Meudon-la-Forêt | 92360 | France |
| Pfizer Investigational Site | Meysieu | 69330 | France |
| Pfizer Investigational Site | Millery | 69390 | France |
| Pfizer Investigational Site | Nogent-sur-Marne | 94130 | France |
| Pfizer Investigational Site | Paris | 75004 | France |
| Pfizer Investigational Site | Paris | 75005 | France |
| Pfizer Investigational Site | Paris | 75015 | France |
| Pfizer Investigational Site | Paris | 75019 | France |
| Pfizer Investigational Site | Paris | 75020 | France |
| Pfizer Investigational Site | Saint-Marcel | 71380 | France |
| Pfizer Investigational Site | Saint-Quentin | 02100 | France |
| Pfizer Investigational Site | Salon-de-Provence | 13300 | France |
| Pfizer Investigational Site | Sartrouville | 78500 | France |
| Pfizer Investigational Site | Sélestat | 67600 | France |
| Pfizer Investigational Site | Strasbourg | 67100 | France |
| Pfizer Investigational Site | Thionville | 57100 | France |
| Pfizer Investigational Site | Tours | 37000 | France |
| Pfizer Investigational Site | Tresses | 33370 | France |
| Pfizer Investigational Site | Vandœuvre-lès-Nancy | 54500 | France |
| Pfizer Investigational Site | Varois-et-Chaignot | 21490 | France |
| Pfizer Investigational Site | Vence | 06140 | France |
| Pfizer Investigational Site | Versailles | 78000 | France |
| ID | Term |
|---|---|
| D014069 | Tonsillitis |
| ID | Term |
|---|---|
| D010612 | Pharyngitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D017963 | Azithromycin |
| D000658 | Amoxicillin |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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