Oral Antibiotics Alone in Children Aged 4 Weeks to 2 Months With a Suspected or Confirmed Uncomplicated Urinary Tract Infection. A Single-arm Multicenter Prospective Observational Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 125
- 试验地点
- 4
- 主要终点
- Number of days admitted related to urinary tract symptoms
研究概览
简要总结
The goal of this prospective study is to investigate whether oral antibiotic therapy alone is feasible and safe in clinically stable children aged 4 weeks to 2 months without any past high-risk medical history with a suspected or confirmed urinary tract infection.
详细描述
All children aged 4 weeks to 2 months with a suspected urinary tract infection will be observed and examined by physicians and nurses as recommended by current guidelines. Children needing empirical antibiotic therapy will be admitted. The remaining will be contacted by phone if the urine culture is positive, and antibiotic therapy will be initiated if a urinary tract infection is still suspected due to persistent symptoms.
Clinically stable (see eligibility criteria) children without any past high-risk medical history (see eligibility criteria) will initiate oral antibiotic therapy. As empirical oral therapy, amoxicillin-clavulanic acid 50 mg/kg/day divided into 3 doses will be used. If the sensitivity pattern is available, a smaller-spectrum antibiotic can be used instead. If these children at any time point become clinically unstable or have a positive blood culture without suspected contamination, parenteral antibiotic therapy will be initiated. As empirical parenteral therapy, gentamicin 5 mg/kg once daily and ampicillin 100 mg/kg/day divided into 3 doses will be used. If the sensitivity pattern is available, another parenteral antibiotic regime can be used instead.
Admitted children can be sent home when they have clinically improved (judged by the physician) and have been hospitalized at least until the ward round the following day. Parents will be informed to contact the pediatric emergency department immediately if the child worsens or does not tolerate the antibiotics.
A physical or virtual follow-up will be conducted on day 3 (approximately 72 hours after treatment initiation) to ensure clinical improvement and treatment adherence. If needed, antibiotic therapy will be changed according to the sensitivity pattern. Children with a negative urine culture will be informed to stop antibiotic therapy.
The duration of antibiotic therapy will be 10 days. All children will undergo a renal ultrasound within the treatment period.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 4 Weeks 至 2 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Oral antibiotic therapy
Clinically stable (see eligibility criteria) children without any past high-risk medical history (see eligibility criteria) will initiate oral antibiotic therapy.
干预措施: Oral antibiotic therapy (Drug)
结局指标
主要结局
Number of days admitted related to urinary tract symptoms
时间窗: Within 28 days after treatment initiation
Proportion of participants with recurrent urinary tract infection regardless of the pathogen or death of any cause
时间窗: Within 28 days after end of treatment
次要结局
- Proportion of participants with a recurrent urinary tract infection regardless of the pathogen or death of any cause.(Within 100 days after end of treatment)
- Number of days with antibiotic-related non-serious adverse events.(From date of treatment initiation until the date of treatment stop for the baseline infection, assessed up to 14 days)
- Proportion of participants with a recurrent infection with a bacterium resistant to the antibiotic given for the baseline infection or an opportunistic infection(Within 100 days after end of treatment)
研究者
Ulrikka Nygaard
Principal investigator
Rigshospitalet, Denmark