PER-063-20尚未招募未知
MULTICENTER, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND CLINICAL TRIAL OF SUPERIORITY IN EFFICACY AND SAFETY OF THE FIXED-DOSE COMBINATION OF CEPHALEXIN AND AMBROXOL (BIOBRONCOL®) VERSUS CEPHALEXIN IN THE TREATMENT OF ACUTE BACTERIAL PHARYNGOTONSILLITIS IN THE PEDIATRIC POPULATION.
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 179
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •- Patients between 2 - 15 years
- •- Clinical diagnosis of bacterial pharyngotonsillitis (4 or more McIsaac Modified Centor criteria) with rapid antigenic detection test for positive or negative GABHS, or less than 4 McIsaac Modified Centor criteria with positive GABHS rapid antigenic detection test.
- •- Signed informed consent form.
- •- SARS COV-2 Negative Rapid Test
排除标准
- •- Concomitant respiratory infections such as acute otitis media, acute sinusitis, pneumonia, subpharyngeal infections or tonsillar abscesses.
- •- History of rheumatic heart disease or valve dysfunction of unknown etiology
- •- Immunosuppression
- •-Skin rash
- •- Compromise of kidney or liver function.
- •- Patients with some type of cancer.
- •- History of recurrent or recent pharyngotonsillitis (more than 3 episodes in the last 6 months or 1 episode in the last month)
- •- Have received oral antibiotics in the last 7 days prior to enrollment in the study or have received cephalosporins in the last three months.
- •- History of hypersensitivity to amoxicillin or type 1 hypersensitivity to penicillin.
- •- History of hypersensitivity to ambroxol.
- •- Pregnancy or lactation.
- •- Concurrent treatment with another antibiotic or with corticosteroids.
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