A Randomized Controlled Study of 5 and 10 Days Treatment With Phenoxymethylpenicillin for Pharyngotonsillitis Caused by Streptococcus Group A
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 433
- 试验地点
- 17
- 主要终点
- Clinical cure
研究概览
简要总结
The primary objective of the study is to compare the clinical efficacy of 5 days (800 mg x 4) versus 10 days (1000 mg x 3) treatment with phenoxymethylpenicillin (PcV) in adults, adolescents and children with streptococcal tonsillitis. Patients are recruited from 17 primary Health care centres in the south of Sweden. Adult men and women, youth and children ≥ 6 years of age who are visiting the primary Health care for sore throat with suspected tonsillitis and meeting the criteria in accordance with current treatment recommendations for pharyngotonsillitis, ie 3-4 Centor criteria (fever≥ 38.5, tender lymph nodes, coatings of the tonsils and absence of cough) and a positive rapid antigen detection test (RADT) for Group A streptococcus (GAS) will be included in the study. Patients will be randomized to be prescribed PcV of 5 and 10 days. Each patient or guardian fills daily in a short diary including aches, fever, PcV doses, pain relievers, adverse events etc. Five to seven days after last intake of PcV the general practioner make a clinical judgement if the patient has recovered from the pharyngotonsillitis. Questions to be asked are if remaining symptoms or new symptoms of sore throat is present, if adverse events have been noted or of any extra physician visits have been made. Throat swab for semi quantitative cultures of Streptococcus group A, C and G are made at randomization and five to seven days after last intake of PcV. A study nurse will contact the patients one month and three months after the last treatment day for follow-up. If the patient has reconsulted or been hospitalised for a sore throat or possible complication, those patient records will be examined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults, adolescents and children ≥ 6 years of age with verified streptococcal pharyngotonsillitis.
排除标准
- •Signs of serious infection.
- •Known hypersensitivity against penicillin.
- •Chronic disease with effect on the immune response.
- •Immunosuppressive treatment.
- •Streptococcal tonsillitis within one month (relapse).
研究组 & 干预措施
5 days
Phenoxymethylpenicillin 800 mg x 4 for 5 days
干预措施: Phenoxymethylpenicillin (Drug)
10 days
Phenoxymethylpenicillin 1000 mg x 3 for 10 days
干预措施: Phenoxymethylpenicillin (Drug)
结局指标
主要结局
Clinical cure
时间窗: 5-7 days after discontinuation of treatment
Difference between treatment groups in the rate of clinical cure. Clinical cure is defined as clinical judgement by physician and absence of Centor criteria (coating, fever and swollen Large Granular Lymphocyte glands).
次要结局
- Frequency of complications(Within 3 months after discontinuation of treatment)
- Bacteriological cure(5-7 days after discontinuation of treatment)
- Frequency of relapses(1 month after discontinuation of treatment)
研究者
Ass. Prof. Katarina Hedin
Professor
Public Health Agency of Sweden
