NCT07845812尚未招募4 期
Short vs Standard Amoxicillin for Pediatric Strep Throat: A Patient-Centered Pragmatic Trial
The University of Texas Health Science Center, Houston1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2026年9月28日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Number of participants that demonstrate resolution of throat pain and fever as reported by the participant/caregiver
研究概览
简要总结
The purpose of this study is to compare 5-day vs 10-day amoxicillin for strep throat in children.
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
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •confirmed Group A streptococcal (GAS) pharyngitis, defined by a positive rapid antigen detection test
- •Receiving care at either the University of Texas Pediatrics General Clinic or the Memorial Hermann Emergency Department
- •Written informed consent obtained from a parent or legal guardian, with assent from the child when developmentally appropriate and required by institutional policy.
排除标准
- •Known allergy or hypersensitivity to penicillin, amoxicillin, or other beta-lactam antibiotics
- •Severe or complicated illness requiring hospitalization at presentation.
- •History of acute rheumatic fever, post-streptococcal glomerulonephritis, or other conditions for which prolonged antibiotic therapy is specifically indicated.
- •Immunocompromised state, including but not limited to: Active malignancy receiving chemotherapy, Solid-organ or hematopoietic stem cell transplant, Chronic systemic immunosuppressive therapy
- •Antibiotic use with activity against Group A Streptococcus within the preceding 7 days.
- •Inability to take oral medications or anticipated inability to complete outpatient therapy.
研究组 & 干预措施
5 day short course antibiotic treatment
Experimental
干预措施: 5 day short course antibiotic treatment (Drug)
10 day standard of care antibiotic treatment
Active Comparator
干预措施: 10 day standard of care antibiotic treatment (Drug)
结局指标
主要结局
Number of participants that demonstrate resolution of throat pain and fever as reported by the participant/caregiver
时间窗: about 14 days after treatment initiation
Number of participants that do not require additional or alternative antibiotic therapy for Group A Streptococcal (GAS) pharyngitis
时间窗: about 14 days after treatment initiation
次要结局
- Number of participants that complete the prescribed antibiotic course, assessed by caregiver report(Day 14)
- Number of participants that demonstrate improvement in treatment tolerance(From baseline to day 14)
- Number of participants that demonstrate improvement in pain(From baseline to day 14)
- Number of participants that demonstrate improvement in fever(From baseline to day 14)
- Number of participants that have Antibiotic-Associated Adverse Effects(From baseline to day 14)
- Number of participants that have recurrence of symptomatic GAS pharyngitis requiring additional medical evaluation or treatment.(From the end of study treatment through Day 30)
- Number of participants with an emergency department visit, urgent care visit, or unplanned clinic encounter related to pharyngitis symptoms(Within 30 days after completion of study treatment)
- Number of school days missed due to pharyngitis-related illness, as reported by the caregiver.(Within 14 days after completion of study treatment)
- Number of caregiver workdays missed due to the child's illness(Within 14 days after completion of study treatment)
研究者
Guliz Erdem
Professor
The University of Texas Health Science Center, Houston
研究点 (1)
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