High-dose Cephalexin for Cellulitis (HI-DOCC)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 454
- 试验地点
- 19
- 主要终点
- Number of Participants with Oral Antibiotic Treatment Failure
研究概览
简要总结
Cellulitis is a common condition diagnosed and managed in the ED that carries significant burden on healthcare systems globally. Cellulitis is the 8th most common reason patients present to an ED in Canada. Among middle-aged patients (45-64 years) it is the 5th most common reason to visit an ED. This disease is responsible for significant healthcare system burden due to high hospitalization rates and subsequent costs. The Investigators conducted a health records review at two large urban EDs in Ottawa, and found that 29.6% of patients with cellulitis are admitted to hospital. In a separate study, The investigators found that the mean cost of care to hospitalize cellulitis patients for IV antibiotics was $10,145 CDN.
详细描述
Background Non-purulent cellulitis is a bacterial skin and soft tissue infection of the subcutaneous tissue. Group A streptococcus (Streptococcus pyogenes), beta-hemolytic streptococci and methicillin-susceptible Staphylococcus aureus are the most common bacteria causing non-purulent cellulitis. Patients typically present to the emergency department (ED) with pain, redness, swelling and induration (skin hardening due to inflammation) of the affected skin. A minority of patients may have fever or tachycardia. The diagnosis of cellulitis is clinical. Once the diagnosis is made, antibiotic treatment is initiated. The emergency physician must select the appropriate agent, oral versus intravenous (IV) route, dose, frequency and duration.
Rationale For ED adult patients with cellulitis, how does high-dose (1000 mg QID) cephalexin compare with standard-dose (500 mg QID) cephalexin with respect to antibiotic treatment failure, adverse events and health service utilization (i.e., need for IV antibiotics, unscheduled return ED visits and hospitalization)? Hypotheses (superiority): Treatment with high-dose cephalexin will lead to lower rates of oral antibiotic treatment failure than using standard-dose cephalexin.
Methods:
Study Design & Setting The investigators will conduct a multicentre, parallel-arm double-blind, individually randomized trial comparing high-dose (1000 mg) cephalexin to standard-dose (500 mg) cephalexin to treat ED adult patients with cellulitis. This is a superiority trial. The trial will be conducted at 8 Canadian EDs. A total sample size of 446 patients (223 per group) will be required.
Study Population Inclusion Criteria The Investigators will include adults (age ≥18 years) diagnosed with non-purulent cellulitis and determined by the treating emergency physician to be eligible for outpatient oral antibiotics.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Eligible patients will be randomized (1:1) to high-dose versus standard-dose arms. The randomization sequence will be computer-generated by a statistician
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults (age ≥18 years) diagnosed with non-purulent cellulitis and determined by the treating emergency physician to be eligible for outpatient oral antibiotics.
排除标准
- •Age <18 years;
- •Patient already taking oral antibiotics;
- •Treating physician decides IV antibiotics are required;
- •Abscess requiring an incision and drainage procedure;
- •Known prior skin or soft tissue infection secondary to methicillin-resistant Staphylococcus aureus (MRSA);
- •Cellulitis secondary to a human or animal bite wound;
- •Penetrating wound or water exposure resulting in cellulitis;
- •Surgical site infection;
- •Patient found at a follow up visit to have an alternative, non-infectious etiology (e.g., deep vein thrombosis);
- •bilateral symptoms (e.g., both legs involved);
- •Malignancy and currently being treated with chemotherapy;
- •Solid organ or bone marrow transplant recipient;
- •Renal impairment with an estimated glomerular filtration rate <30 mL/min documented on the health record at any time within the past three months;
- •Allergy to cephalosporins or history of anaphylaxis to penicillin;
- •Inability to provide informed consent
研究组 & 干预措施
High Dose Cephalexin
The intervention is high-dose cephalexin (1000mg PO QID) for seven days
干预措施: Cephalexin (Drug)
Standard Dose Cephalexin
The comparator is standard-dose cephalexin (500mg PO QID) plus oral placebo for seven days
干预措施: Cephalexin (Drug)
结局指标
主要结局
Number of Participants with Oral Antibiotic Treatment Failure
时间窗: 7 days
defined as a change in antibiotic (change in class of oral antibiotic or step up to IV therapy) within 7 days due to worsening infection. Any of the following meet criteria for worsening infection (at day 3 or 8 follow-up): (1) New fever (temperature ≥38.0C) or persistent fever at follow-up; (2) Increasing area of erythema (in cm2) ≥20% from baseline; or (3) Increasing pain ≥2 points from baseline (using the numeric rating scale).
次要结局
- Number of Participants with clinical cure(evaluated at day 8 and day 30)
- Number of Participants with clinical response(evaluated at days 3 and 8)
- Number of Participants with unplanned visits to a healthcare provider for cellulitis(30 days)
- Number of Participants with unplanned hospitalization for cellulitis(30 days)
- Number of Participants with adverse events(30 days)
- Number of Participants with antibiotic intolerance(7 days)
- Number of Participants with antibiotic allergy(7 days)
- Number of Participants with medication adherence(7 days)
- Number of Participants with health-related quality of life(30 days)
- Change in antibiotic but not meeting worsening infection(Evaluated at 30 days)
- Additional antibiotics(Evaluated at 30 days)
- Recurrence(Evaluated at 30 days)
- Number of Participants with unplanned visits to a healthcare provider for cellulitis(30 days)
- Number of Participants with antibiotic intolerance(7 days)
- Number of Participants with clinical cure(evaluated at day 8 and day 30)
- Number of Participants with clinical response(evaluated at days 3 and 8)
- Number of Participants with unplanned hospitalization for cellulitis(30 days)
- Number of Participants with adverse events(30 days)
- Number of Participants with antibiotic allergy(7 days)
- Number of Participants with medication adherence(7 days)
- Number of Participants with health-related quality of life(30 days)