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临床试验/NCT04401553
NCT04401553撤回4 期

First Tier Versus Second Tier Antibiotics for Surgical Site Infections Following Hysterectomy In the Patients With a Beta-Lactam Allergy: A Prospective, Randomized, Single-Blinded Clinical Trial

University of Texas Southwestern Medical Center0 个研究点开始时间: 2024年8月16日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
撤回
主要终点
Surgical site infections during early postoperative period

研究概览

简要总结

Postoperative surgical site infection (SSI) is associated with unnecessary use of heath care resources including prolonged hospitalization and increased hospital readmission. Perioperative antibiotic prophylaxis is one of the most important strategies for prevention of SSI. If there is a beta-lactam allergy, second tier antibiotics (vancomycin and clindamycin) are recommended alternatives to first- and second-generation cephalosporins because of fears of possible allergy.

This prospective, randomized, and single-blinded clinical trial is designed to examine causality between second tier antibiotics use and surgical site infections in the subjects with a documented unverified penicillin allergy. Unverified beta-lactam allergy could be associated with antimicrobial treatment failure with second tires antibiotics during postoperative period.

详细描述

In this prospective, randomized, single-blinded clinical trial, eligible subjects will be identified based on scheduled elective hysterectomy. Subjects with documented beta-lactam allergy in their chart will be evaluated to differentiate true allergy and allergy-like events. Subjects with history of allergy-like event to beta-lactam antibiotics will be randomized to either receive first tier antibiotic or second tier antibiotics before anesthesia induction.

Preoperative Screening of Allergy The potential subjects' history of allergy will be reviewed according to described criteria of allergy like events. Subjects with documented anaphylaxis to first tier and second tier antibiotics will be excluded. Only subjects with a history of previous allergic-like event after beta-lactam antibiotic will be enrolled to the study.

An allergy self-screening questionnaires will be reviewed before the surgery to identify true allergy or allergy-like event to beta-lactam (penicillin). Allergic-like events include nausea, vomiting, feeling dizziness, dermatitis seen after beta-lactam antibiotic, or any other description of hypersensitivity reactions other than anaphylactic shock, angioedema, laryngeal spasm, and shock. Administration of the potential confounding drugs such as antihistamines, systemic and topical corticosteroids and potential confounding diagnosis such as autoimmune disease will be also reviewed together with allergy history of the subjects to differentiate true hypersensitivity and allergy-like events to penicillin and other beta-lactam antibiotics.

Postoperative Follow-up for SSI:

Subjects will be followed postoperatively for post-discharge SSIs or clostridium infection by reviewing medical records and contacting via phone and survey. If the subject received care outside the clinic, their provider will be contacted to obtain outside clinic record with subject permission.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • The subjects age 18 and older
  • Subjects undergoing open total abdominal hysterectomy
  • Subjects with documented beta-lactam allergy

排除标准

  • Subjects with documented anaphylaxis to Tier 1 or Tier 2 antibiotics
  • Surgical procedure within 30 days prior to hysterectomy
  • Robotic hysterectomy
  • Presence of multidrug resistant organism such as methicillin-resistant Staphylococcus aureus (MRSA)
  • Immunocompromised subject
  • Cognitive deficits 7- Chronic Kidney Disease or patients on dialysis 8- Severe liver disease

研究组 & 干预措施

First Tier Antibiotic

Experimental

First tier antibiotics, cephalosporin, will be given before anesthesia induction in the subjects with a history of allergy-like event to beta-lactam

干预措施: cephalosporin (Drug)

Second Tier Antibiotic

Active Comparator

Second tier antibiotics, vancomycin, will be given before anesthesia induction for infection prevention in the subjects with a history of allergy-like event to beta-lactam

干预措施: Second tier antibiotic (Vancomycin) (Drug)

结局指标

主要结局

Surgical site infections during early postoperative period

时间窗: Early post-operative period within a 30-day after hysterectomy

Incidence of surgical site infections after hysterectomy

次要结局

  • Infectious hospital readmission(the postoperative period within a 90-days after hysterectomy)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mark Haney

Assistant Professor

University of Texas Southwestern Medical Center

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