Antimicrobial Stewardship in Pediatric Surgery (AbxPS)
2018年3月16日 更新者：Dr Anna Shawyer、Alberta Children's Hospital
An Antimicrobial Stewardship Intervention Program in Pediatric Surgery
Acute appendicitis is a common surgical emergency in children. Non-perforated appendicitis patients do not require antibiotics after appendectomy. Although guidelines and recommendations exist to decrease post-operative antibiotic mis-use after appendectomy, surgeons continue to prescribe unwarranted antibiotics.
The aim of this study is to determine if an Antimicrobial Stewardship Program in Pediatric Surgery will decrease the use of un-warranted antibiotics.
調査の概要
詳細な説明
Many surgeons continue to treat non-perforated or "borderline perforated" appendicitis with postoperative antibiotics despite an evidence-based definition of perforation (in the pediatric surgical literature) and many guidelines and recommendations that specify that no postoperative antibiotics are required. Children with perforated appendicitis are also often treated with longer-than-necessary courses of antibiotics. Although surgeons may feel that they only prescribe additional doses on occasion, evidence suggests that this behavior occurs in over 50% of children with non-perforated appendicitis.
These additional doses contribute to a longer length of stay, excess costs to the health care system, and disrupt patient flow. Additionally, the patients are exposed to more antibiotics and their potential for adverse effects (such as incorrect dose, incorrect medication, allergic reaction, antimicrobial resistance or c difficile infection).
Antimicrobial stewardship programs have been successful in pediatrics and adult general surgery in curbing unwarranted antibiotic use, but have never been evaluated in pediatric general surgery.
研究の種類
観察的
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳未満 (子、大人)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
サンプリング方法
確率サンプル
調査対象母集団
The study population is the pediatric surgeons at our institution who will have their antibiotic prescribing audited.
説明
Inclusion Criteria:
- Participant (surgeon) is a pediatric surgeon at McMaster Children's Hospital and takes care of patients under the age of 18 who undergo appendectomy.
- Participant (surgeon) is able to read, write and understand English.
- Participant (surgeon) is able to provide informed consent.
Exclusion Criteria:
- Participant (surgeon) only has patients who undergo drain insertion, PICC line insertion or a secondary operation during the same admission
- Participant (surgeon) only has patients who do not undergo operation (i.e. "conservative management with interval appendectomy)
- Participant (surgeon) does not provide informed consent
- Participant (surgeon) does not understand written and spoken English diagnosis other than appendicitis at time of operation
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
NO Antimicrobial Stewardship Program
Prospective cohort of children who undergo appendectomy for acute appendicitis (perforated and non-perforated) BEFORE the implementation of the Antimicrobial Stewardship Program.
|
|
|
WITH Antimicrobial Stewardship Program
Prospective cohort of children who undergo appendectomy for acute appendicitis (perforated and non-perforated) WITH the implementation of the Antimicrobial Stewardship Program.
|
Twice weekly meeting with Infectious Disease and Pediatric Surgery team members to audit antibiotics prescribed and suggest role for discontinuation.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Compliance with American Pediatric Surgical Association recommendations for postoperative antibiotics for appendicitis
時間枠：From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
|
Includes both intravenous and oral antibiotics prescribed, both during the time frame from admission until discharge, in addition to any prescription given for home, oral antibiotics.
Measured as yes/no
|
From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Postoperative intravenous antibiotics for non-perforated appendicitis
時間枠：From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
|
measured as number of days (ie number of doses divided by number of doses-per-day)
|
From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
|
|
Postoperative oral antibiotics for non-perforated appendicitis
時間枠：From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
|
measured as number of days (ie number of doses divided by number of doses-per-day)
|
From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Postoperative fever
時間枠：Length of admission
|
Rectal temperature above 100.4ºF
(38ºC), measured as yes/no and on what postoperative day Oral temperature above 100ºF (37.8ºC)
Axillary (armpit) temperature above 99ºF (37.2ºC)
Ear (tympanic membrane) temperature above 100.4ºF
(38ºC) in rectal mode or 99.5ºF (37.5ºC) in oral mode Forehead (temporal artery) temperature above 100.4ºF
(38ºC)
|
Length of admission
|
|
Readmission within 30 days
時間枠：Within 30 days of discharge
|
Need for readmission within 30 days of discharge, measured as yes/no
|
Within 30 days of discharge
|
|
Peripherally inserted intravenous catheter (PICC)
時間枠：From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
|
Need for PICC insertion for long term antibiotics, intravenous fluids or parenteral nutrition, measured as yes/no
|
From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
|
|
Drain insertion
時間枠：From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
|
Need for a drain insertion (by interventional radiology) for postoperative abscess, measured as yes/no
|
From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
|
|
Re-operation
時間枠：From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
|
Need for re-operation on the same admission, measured as yes/no
|
From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
|
|
Length of Stay
時間枠：Length of admission
|
Measured in days (from date of admission until date of discharge)
|
Length of admission
|
|
Adverse reaction to antibiotic
時間枠：From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
|
Measured as yes/no in addition to description of reaction (eg hives, shortness of breath)
|
From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
|
|
Wrong medication/Wrong dose
時間枠：From date of admission until date of first follow-up visit, typically within 4-6 weeks of discharge
|
Measured as yes/no in addition to description of problem (wrong dose, wrong medication)
|
From date of admission until date of first follow-up visit, typically within 4-6 weeks of discharge
|
|
C difficile infection
時間枠：From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
|
Measured as yes/no based on stool assay
|
From date of admission until first follow-up visit, typically within 4-6 weeks of discharge
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Anna Shawyer, MS, MSc、Alberta Children's Hospital
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- St Peter SD, Sharp SW, Holcomb GW 3rd, Ostlie DJ. An evidence-based definition for perforated appendicitis derived from a prospective randomized trial. J Pediatr Surg. 2008 Dec;43(12):2242-5. doi: 10.1016/j.jpedsurg.2008.08.051.
- Lee SL, Islam S, Cassidy LD, Abdullah F, Arca MJ; 2010 American Pediatric Surgical Association Outcomes and Clinical Trials Committee. Antibiotics and appendicitis in the pediatric population: an American Pediatric Surgical Association Outcomes and Clinical Trials Committee systematic review. J Pediatr Surg. 2010 Nov;45(11):2181-5. doi: 10.1016/j.jpedsurg.2010.06.038.
- Srigley JA, Brooks A, Sung M, Yamamura D, Haider S, Mertz D. Inappropriate use of antibiotics and Clostridium difficile infection. Am J Infect Control. 2013 Nov;41(11):1116-8. doi: 10.1016/j.ajic.2013.04.017. Epub 2013 Aug 7.
- Rangel SJ, Fung M, Graham DA, Ma L, Nelson CP, Sandora TJ. Recent trends in the use of antibiotic prophylaxis in pediatric surgery. J Pediatr Surg. 2011 Feb;46(2):366-71. doi: 10.1016/j.jpedsurg.2010.11.016.
- Ghaleb MA, Barber N, Franklin BD, Wong IC. The incidence and nature of prescribing and medication administration errors in paediatric inpatients. Arch Dis Child. 2010 Feb;95(2):113-8. doi: 10.1136/adc.2009.158485. Epub 2010 Feb 4.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2015年1月1日
一次修了 (予想される)
2015年12月1日
研究の完了 (予想される)
2015年12月1日
試験登録日
最初に提出
2014年10月8日
QC基準を満たした最初の提出物
2014年10月21日
最初の投稿 (見積もり)
2014年10月22日
学習記録の更新
投稿された最後の更新 (実際)
2018年3月20日
QC基準を満たした最後の更新が送信されました
2018年3月16日
最終確認日
2018年3月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。