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The purpose of the study is to assess the efficacy of amoxicillin-clavulanate in treating acute otitis media in children. The primary end point is time to disappearance of middle ear effusion which monitored by daily tympanometry performed by families and study physicians.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amoxicillin-clavulanate | Experimental | Oral amoxicillin-clavulanate 40 mg/kg/day divided in two daily doses for 7 days |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amoxicillin-clavulanate | Drug | Amoxicillin-clavulanate 40 mg/kg/day in two daily doses for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time (days) to disappearance of middle ear effusion | Disappearance of middle ear effusion is defined as the first day of receiving a normal tympanogram (A-curve) in tympanometry. | Within 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time (days) to disappearance of pain | Within 60 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matti Uhari, Professor | University of Oulu | Study Director |
| Terhi Tapiainen, MD, PhD | University of Oulu | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pediatrics, Oulu University Hospital | Oulu | 90014 | Finland | |||
| Lääkärikeskus Mehiläinen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24797294 | Derived | Tapiainen T, Kujala T, Renko M, Koivunen P, Kontiokari T, Kristo A, Pokka T, Alho OP, Uhari M. Effect of antimicrobial treatment of acute otitis media on the daily disappearance of middle ear effusion: a placebo-controlled trial. JAMA Pediatr. 2014 Jul;168(7):635-41. doi: 10.1001/jamapediatrics.2013.5311. |
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| ID | Term |
|---|---|
| D010035 | Otitis Media, Suppurative |
| D010034 | Otitis Media with Effusion |
| ID | Term |
|---|---|
| D013492 | Suppuration |
| D007239 | Infections |
| D010033 | Otitis Media |
| D010031 | Otitis |
| D004427 |
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| ID | Term |
|---|---|
| D019980 | Amoxicillin-Potassium Clavulanate Combination |
| ID | Term |
|---|---|
| D019818 | Clavulanic Acid |
| D002969 | Clavulanic Acids |
| D047090 | beta-Lactams |
| D007769 | Lactams |
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| Placebo | Drug | Placebo mixture in two daily doses for 7 days |
|
| Oulu |
| 90100 |
| Finland |
| Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| 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 |