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临床试验/NCT02712307
NCT02712307已完成4 期

A Randomized Controlled Study of 5 and 10 Days Treatment With Phenoxymethylpenicillin for Pharyngotonsillitis Caused by Streptococcus Group A

Ass. Prof. Katarina Hedin17 个研究点 分布在 1 个国家目标入组 433 人开始时间: 2015年9月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

Phenoxymethylpenicillin 800 mg x 4 for 5 days

干预措施: Phenoxymethylpenicillin (Drug)

10 days

Active Comparator

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

发起方
Ass. Prof. Katarina Hedin
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Ass. Prof. Katarina Hedin

Professor

Public Health Agency of Sweden

研究点 (17)

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