Metronidazole Every 24 Hours as Part of Triple Antibiotic Therapy for Ruptured Appendicitis in Children Managed Operatively (METRO): a Noninferiority Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 主要终点
- Length of stay
研究概览
简要总结
The objective of this study is to determine whether administering once-daily doses of metronidazole, an intravenous (IV) antibiotic used to prevent infection in perforated appendicitis, is as effective in children as delivering it in the standard method of once every eight hours. Reducing the frequency of administration has the potential of decreasing personnel time and healthcare cost and increasing the lifespan of the IV line.
To determine the effectiveness once-daily administration, a randomized controlled trial (RCT) will be conducted to compare outcomes between the two treatment schedules. We will recruit 100 patients (50 per treatment) aged 5-18 being surgically treated for perforated appendicitis at the Children's Hospital of Eastern Ontario, who will be randomly assigned to one of the two treatment schedules. To compare the efficacy of the treatments, outcomes such as duration of hospital stay and theoretical cost will be measured and analyzed using statistical tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All children 5-18 years of age, presenting to CHEO with perforated appendicitis (confirmed either in the operating room or diagnosed preoperatively according to radiological criteria), and managed surgically will be assessed for eligibility to participate. These patients may participate if baseline lab values of serum AST (SGOT), AL T (SGPT), LDH, triglycerides and hexokinase glucose are normal, complete physical exam is normal, hGC test is negative for pregnancy (if the patient is a female of reproductive age) and none of the exclusion criteria are present.
排除标准
- •Any known co-existing gastrointestinal disease
- •Uncertainty about the diagnosis
- •Perforated appendicitis with diffuse abdominal fluid on imaging associated with a clinical picture of severe sepsis
- •A known allergy to any of the antibiotics to be used in this trial
- •An active neurological disorder
- •Receiving medical treatment for a neurological disorder
- •A history of blood dyscrasia, hypothyroidism or hypoadrenalism
- •Hepatic disease
- •Renal impairment
- •Patients receiving any other oral or intravenous concomitant antimicrobial at enrollment
- •Pregnancy
- •Under five years of age
- •Patients who have received metronidazole orally or intravenously in the last 14 days, prior to the current admission for appendicitis
- •Patients already taking any of the following medications at admission (as these may interact with Metronidazole as stated in the product monograph): disulfiram, oral anticoagulant therapy (warfarin type), phenytoin or phenobarbital, vecuronium, lithium, busulfan
- •The physician elects to treat the patient conservatively (non-surgically)
研究组 & 干预措施
q24h
Metronidazole given once daily
干预措施: Metronidazole (Drug)
q8h
Metronidazole given every 8 hours
干预措施: Metronidazole (Drug)
结局指标
主要结局
Length of stay
时间窗: until discharge (usually less than one week after admission)
• Duration of hospital stay (in days) during initial admission for perforated appendicitis (Patient will be discharged when eating normal diet, afebrile for 24 hours and no abdominal pain)
次要结局
- Quantity of narcotics(From date of randomization to date of death from any cause or three months after initial discharge from hospital, whichever comes first.)
- Duration of antibiotics oral(From date of randomization to date of death from any cause or three months after initial discharge from hospital, whichever comes first.)
- Duration of narcotics(From date of randomization to date of death from any cause or three months after initial discharge from hospital, whichever comes first.)
- Duration of antibiotics IV(From date of randomization to date of death from any cause or three months after initial discharge from hospital, whichever comes first.)
- Theoretical cost in CAD(From date of randomization to date of death from any cause or three months after initial discharge from hospital, whichever comes first.)
- Failure of antibiotics(during hospital stay (usually less than one week))
研究者
Ahmed Nasr
Principal Investigator
Children's Hospital of Eastern Ontario