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Trial record 12 of 26566 for:    Anti-Infective Agents

Antimicrobial Stewardship in Pediatric Surgery (AbxPS)

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ClinicalTrials.gov Identifier: NCT02270996
Recruitment Status : Withdrawn
First Posted : October 22, 2014
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
Dr Anna Shawyer, Alberta Children's Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment
Appendicitis Other: Antimicrobial Stewardship Program

Detailed Description:

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.


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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Antimicrobial Stewardship Intervention Program in Pediatric Surgery
Study Start Date : January 2015
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Other: Antimicrobial Stewardship Program
Twice weekly meeting with Infectious Disease and Pediatric Surgery team members to audit antibiotics prescribed and suggest role for discontinuation.




Primary Outcome Measures :
  1. Compliance with American Pediatric Surgical Association recommendations for postoperative antibiotics for appendicitis [ Time Frame: 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


Secondary Outcome Measures :
  1. Postoperative intravenous antibiotics for non-perforated appendicitis [ Time Frame: 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)

  2. Postoperative oral antibiotics for non-perforated appendicitis [ Time Frame: 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)


Other Outcome Measures:
  1. Postoperative fever [ Time Frame: 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)

  2. Readmission within 30 days [ Time Frame: Within 30 days of discharge ]
    Need for readmission within 30 days of discharge, measured as yes/no

  3. Peripherally inserted intravenous catheter (PICC) [ Time Frame: 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

  4. Drain insertion [ Time Frame: 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

  5. Re-operation [ Time Frame: 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

  6. Length of Stay [ Time Frame: Length of admission ]
    Measured in days (from date of admission until date of discharge)

  7. Adverse reaction to antibiotic [ Time Frame: 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)

  8. Wrong medication/Wrong dose [ Time Frame: 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)

  9. C difficile infection [ Time Frame: From date of admission until first follow-up visit, typically within 4-6 weeks of discharge ]
    Measured as yes/no based on stool assay



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The study population is the pediatric surgeons at our institution who will have their antibiotic prescribing audited.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02270996


Sponsors and Collaborators
Alberta Children's Hospital
Investigators
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Principal Investigator: Anna Shawyer, MS, MSc Alberta Children's Hospital

Publications of Results:
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Responsible Party: Dr Anna Shawyer, Dr. Anna Shawyer, Alberta Children's Hospital
ClinicalTrials.gov Identifier: NCT02270996     History of Changes
Other Study ID Numbers: ACH PedSurg ACS 002
First Posted: October 22, 2014    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018

Keywords provided by Dr Anna Shawyer, Alberta Children's Hospital:
antibiotic, antimicrobial, stewardship, child

Additional relevant MeSH terms:
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Appendicitis
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Anti-Infective Agents
Anti-Bacterial Agents