High-dose Cephalexin for Cellulitis: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Patient Recruitment Rate
研究概览
简要总结
Cellulitis is a painful bacterial infection of the skin and underlying tissue that needs antibiotic treatment. There are approximately 193,000 visits to Canadian emergency departments (EDs) each year for cellulitis. Emergency doctors who treat patients with cellulitis must decide on the correct antibiotic agent, dose, duration and frequency. Cellulitis is most commonly treated with the oral antibiotic cephalexin. However, there has been little research to guide doctors with respect to cellulitis treatment, which has led to an overuse of intravenous antibiotics. In addition, the current treatment failure rate of 20% is unacceptably high. When compared to standard-dose oral cephalexin, high-dose oral cephalexin may reduce treatment failure, which would help decrease the need for intravenous antibiotics and subsequent hospitalization. A well-designed clinical trial is necessary to determine if high-dose oral cephalexin reduces treatment failure for cellulitis patients. This pilot trial will determine the feasibility and design of such a clinical trial.
详细描述
Background: Cellulitis is a common clinical condition that represents up to 3% of all emergency department (ED) visits. The current treatment failure rate is approximately 20%. This high treatment failure rate may be due to suboptimal dosing of cephalexin. The Investigators hypothesize that high-dose cephalexin may lead to lower rates of treatment failure and subsequently improved patient outcomes (less hospitalizations and avoidance of intravenous antibiotics)
Rationale: Before embarking on a large, multicenter trial, it is essential to conduct a smaller pilot to test and refine study procedures and to demonstrate feasibility.
Methods:
Design: The investigators will conduct a parallel arm double-blind randomized controlled pilot trial at the Civic and General campus ED of The Ottawa Hospital (TOH). The study will operate seven days a week from 0800 to 2000 over a 6-month timeframe. TOH Pharmacy will follow a randomization sequence and prepare study medication packages. Study medication packages will be dispensed to the patient by a registered nurse (RN).
Patients: Adult (age >=18 years) ED patient with non-purulent cellulitis determined by the treating emergency physician to be eligible for outpatient care with 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) with non-purulent cellulitis determined by the treating emergency physician to be eligible for outpatient care with oral antibiotics.
排除标准
- •Age <18 years
- •Patient already taking oral antibiotics
- •Treating physician decides that intravenous therapy is required
- •Abscess requiring an incision and drainage or needle aspiration procedure
- •Known prior cellulitis secondary to methicillin-resistant Staphylococcus aureus
- •Cellulitis secondary to a human or animal bite wound
- •Surgical site infection
- •Malignancy and currently being treated with chemotherapy
- •Febrile neutropenia (temperature >=38C plus absolute neutrophil count <500 cells/uL)
- •Solid organ or bone marrow transplant recipient
- •Renal impairment with creatinine clearance <30 mL/min
- •Pregnant or breastfeeding
- •Allergy to cephalosporins or history of anaphylaxis to penicillin
- •Inability to provide 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 + placebo (Drug)
结局指标
主要结局
Patient Recruitment Rate
时间窗: 6 months
% of patients recruited into the trial
Oral Antibiotic Treatment Failure
时间窗: Each patient was assessed for oral antibiotic treatment failure at the day 3 and day 7 follow-ups
% of patients with oral antibiotic treatment failure Oral antibiotic treatment failure, defined as a change in antibiotic (change in class of oral antibiotic or step up to intravenous therapy) within 7 days due to worsening infection, which is defined as: 1. New fever (temperature ≥ 38.0°C) or persistent fever at Day 3 follow up; or 2. Increasing area of erythema ≥20% from baseline; or 3. Increasing pain ≥2 points from baseline (numeric rating scale)
次要结局
- Ability to Approach Eligible Patients(6 months)
- Assessment of Blinding(Patient were asked which dose of cephalexin they believe they received during the day 7 follow-up)
- Protocol Adherence(7 days)
- Loss to Follow-up(Determined at final follow-up (day 14) if lost to follow-up)
- Clinical Cure(Assessed for clinical cure at day 7and day 14 follow-up)
- Adverse Events(14 days)
- Unplanned ED Visits or Hospitalization(14 days)