High-dose cephalexin for cellulitis: a pilot randomized controlled trial,Canadian Journal of Emergency Medicine

当前位置： X-MOL 学术 › Can. J. Emerg. Med. › 论文详情

Our official English website, www.x-mol.net, welcomes your feedback! (Note: you will need to create a separate account there.)

High-dose cephalexin for cellulitis: a pilot randomized controlled trial
Canadian Journal of Emergency Medicine ( IF 2.0 ) Pub Date : 2023-01-02 , DOI: 10.1007/s43678-022-00433-7
Krishan Yadav _{1,

2,

3,

4} , Debra Eagles _{1,

2,

3} , Jeffrey J Perry _{1,

2,

3} , Monica Taljaard _{2,

3} , Gabriel Sandino-Gold ₃ , Marie-Joe Nemnom ₃ , Vicente Corrales-Medina _{3,

5} , Kathryn N Suh _{3,

5} , Ian G Stiell _{1,

2,

3}

Affiliation

Background

Up to 3% of all Emergency Department (ED) visits are due to skin and soft tissue infections such as non-purulent cellulitis. The current treatment failure rate is approximately 20%. Evidence is lacking regarding the optimal outpatient management of cellulitis.

Objectives

To evaluate the feasibility of a randomized trial comparing high-dose (1000 mg) to standard-dose (500 mg) cephalexin to treat ED patients with cellulitis.

Methods

A parallel arm double-blind randomized controlled pilot trial conducted at two EDs in Canada. Eligible participants were adults (age ≥ 18 years) presenting to the ED with non-purulent cellulitis and determined by the treating emergency physician to be eligible for outpatient management with oral antibiotics. Participants were randomized to high-dose or standard-dose cephalexin four times daily for 7 days. The primary feasibility outcome was participant recruitment rate (target ≥ 35%). The preliminary primary effectiveness outcome was oral antibiotic treatment failure.

Results

Of 134 eligible participants approached for trial participation, 69 (51.5%, 95% CI 43.1 to 59.8%) were recruited and randomized. After excluding three randomized participants due to an alternate diagnosis, 33 participants were included in each arm. Nineteen eligible cases (14.2%) were missed. Loss to follow-up was 6.1%. Treatment failure occurred in four patients (12.9%) in the standard-dose arm versus one patient (3.2%) in the high-dose arm. A greater proportion had minor adverse events in the high-dose arm. No patients had an unplanned hospitalization within 14 days.

Conclusion

This pilot randomized controlled trial comparing high-dose to standard-dose cephalexin for ED patients with cellulitis demonstrated a high participant recruitment rate and that a full-scale trial is feasible. High-dose cephalexin had fewer treatment failures but with a higher proportion of minor adverse effects. The findings of this pilot will be used to inform the design of a future large trial.

Trial registration

This trial was registered at ClinicalTrials.gov (NCT04471246).

中文翻译：

大剂量头孢氨苄治疗蜂窝组织炎：一项随机对照试验

背景

高达 3% 的急诊科 (ED) 就诊是由于皮肤和软组织感染，例如非化脓性蜂窝组织炎。目前治疗失败率约为20%。缺乏关于蜂窝组织炎最佳门诊管理的证据。

目标

评估比较高剂量（1000 毫克）和标准剂量（500 毫克）头孢氨苄治疗 ED 蜂窝织炎患者的随机试验的可行性。

方法

在加拿大的两个急诊室进行的平行臂双盲随机对照试点试验。符合条件的参与者是因非化脓性蜂窝组织炎到急诊室就诊并由主治急诊医师确定有资格接受口服抗生素门诊治疗的成人（年龄≥18 岁）。参与者被随机分配到高剂量或标准剂量头孢氨苄，每天四次，持续 7 天。主要可行性结果是参与者招募率（目标 ≥ 35%）。初步的主要有效性结果是口服抗生素治疗失败。

结果

在参与试验的 134 名符合条件的参与者中，招募并随机分配了 69 名（51.5%，95% CI 43.1 至 59.8%）。由于替代诊断排除了三名随机参与者后，每组包括 33 名参与者。漏诊了 19 例符合条件的病例 (14.2%)。失访率为 6.1%。标准剂量组有 4 名患者 (12.9%) 发生治疗失败，而高剂量组有 1 名患者 (3.2%) 发生治疗失败。更大比例的人在高剂量组中有轻微的不良事件。没有患者在 14 天内意外住院。