StopStop@HITH - Clinical Efficacy of Stopping Oral Antibiotics When Symptoms Stop, Compared to 'Finishing the Course', for Children With Bacterial Infections Through Hospital-in-the-Home (HITH): a Basket Randomised Controlled Trial (RCT)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The proportion of children with clinical failure within 28 days of initial dose of antibiotics, defined as the requirement to restart antibiotics (either IV or oral) due to the reoccurrence of symptoms attributable to study condition [basket 1]
研究概览
简要总结
The aim of the StopStop@HITH study is to see if stopping antibiotics when symptoms stop is as good as finishing the course of antibiotics. The study will enrol children at the Royal Children's Hospital who are prescribed oral antibiotics after completing a course of intravenous (IV) antibiotics for the treatment of cellulitis, urinary tract infection (UTI), lower respiratory tract infection (LRTI) and lymphadenitis.
The aims of the study are:
- To determine if oral antibiotics can be safely stopped once symptoms stop in children with cellulitis (who have completed a course of IV antibiotics).
- To assess feasibility of a larger study of other common infections across multiple hospitals.
The participants parent/guardian will complete a daily symptom tracker for the duration of the prescribed oral antibiotic course and attend a telehealth appointment with the study team once the participants symptoms have resolved. There are additional follow up surveys at day 14, day 28 and day 180.
详细描述
This is a single-centre, basket, randomised controlled trial (RCT). There are four baskets in the trial related to infection type - cellulitis (basket 1), urinary tract infection (UTI) (basket 2), lower respiratory tract infection (LRTI) (basket 3) and lymphadenitis (basket 4). The primary objective (related to non-inferiority of efficacy) will be evaluated in children with cellulitis (basket 1) and the trial is powered for this objective. Secondary objectives related to feasibility will be evaluated in baskets 2-4 and will be used to inform a larger multi-site RCT to evaluate efficacy in these populations.
Children admitted to the Royal Children's Hospital (RCH) who are initially treated with IV antibiotics will be enrolled, and will then be switched to oral antibiotics to complete treatment for their infection. In all baskets, children in intervention arms will stop antibiotics when symptoms stop, children in control arms will finish their course of antibiotics as prescribed as standard of care. Recruitment will start with patients on the Hospital in the Home (HITH) program, and progress to including patients from inpatient wards who will be monitored through the clinical governance of HITH.
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
- 1 Year 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between the ages of ≥ 1 years and ≤ 17 years at enrolment
- •Diagnosis of cellulitis, urinary tract infection (UTI), lower respiratory tract infection (LRTI) or lymphadenitis
- •Prescription of oral antibiotics as a switch from IV antibiotics
排除标准
- •Clinician determined need for >10-day oral antibiotic course
- •Child with immunosuppression (e.g. as a result of cancer treatment)
- •Second episode of same bacterial infection within the last 28 days
- •Child is unable to take oral antibiotics
- •Previous enrolment in StopStop@HITH
- •Parent/guardian does not speak English
- •Clinician determined need for 10-day course of oral antibiotics for treatment/clearance of streptococcal infection
- •UTI only: known impaired renal function (e.g. renal transplant patients or known chronic renal failure)
- •LRTI only: known chronic respiratory condition (e.g. cystic fibrosis or bronchiectasis) or need for long term respiratory support (e.g. home oxygen, Continuous Positive Airway Pressure [CPAP] or tracheostomy); empyema or lung abscess
研究组 & 干预措施
Intervention arm
Oral antibiotics for the duration of the child's symptoms (minimum 3 days IV plus oral)
干预措施: Antibiotics for duration of symptoms (Drug)
Control arm
Oral antibiotics for the duration of the prescribed course (as per RCH Clinical Practice Guidelines for each infection)
干预措施: Antibiotics for duration of prescribed course (Drug)
结局指标
主要结局
The proportion of children with clinical failure within 28 days of initial dose of antibiotics, defined as the requirement to restart antibiotics (either IV or oral) due to the reoccurrence of symptoms attributable to study condition [basket 1]
时间窗: Day 14 & Day 28
The need to restart antibiotics will be assessed by a clinician independent of the study (e.g. General practitioner \[GP\], HITH or Emergency Department \[ED\] clinician). The need to restart antibiotics will be documented on the follow up study-specific survey via REDCap and will be completed by the parent/guardian at 14 and 28 days.
次要结局
- The proportion of children with clinical failure within 28 days of initial dose of antibiotics defined as the requirement to restart antibiotics (either IV or oral) due to the reoccurrence of symptoms attributable to study condition [basket 2-4](Day 14 & Day 28)
- The proportion of children who, after telehealth review, can stop antibiotics early i.e. at the time of symptom resolution [baskets 1-4](Day 10)
- The number of days taking oral antibiotics [baskets 1-4](Baseline to Day 28)
- The proportion of children with antimicrobial resistant [AMR] pathogens (ESBL or MRSA) on day 28 [baskets 1-4](Day 28)
- The number of adverse events [baskets 1-4](Baseline to Day 14)
- The proportion of children with parent-reported reoccurrence of study condition within six months of initial antibiotic dose [baskets 1-4](Day 180)
- The proportion of children with parent reported occurrence of any AMR infection within 6 months of initial antibiotic dose [baskets 1-4](Day 180)