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Two Different Antibiotics Versus One Antibiotic for Pediatric Perforated Appendicitis

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ClinicalTrials.gov Identifier: NCT03289351
Recruitment Status : Recruiting
First Posted : September 20, 2017
Last Update Posted : August 30, 2019
Sponsor:
Information provided by (Responsible Party):
Phoenix Children's Hospital

Tracking Information
First Submitted Date  ICMJE September 18, 2017
First Posted Date  ICMJE September 20, 2017
Last Update Posted Date August 30, 2019
Actual Study Start Date  ICMJE May 22, 2017
Estimated Primary Completion Date December 22, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2017)
Postoperative Intra-abdominal Abscess [ Time Frame: 30 days ]
Intra-abdominal abscess documented by ultrasound or computerized tomography
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2019)
  • Postoperative Surgical Site Infection [ Time Frame: 30 days ]
    surgical site infections including superficial port site infection
  • Postoperative Readmission [ Time Frame: 30 days ]
    readmission within 30 days for any gastrointestinal complaints or infectious complications
  • Postoperative Antibiotic Charge [ Time Frame: 30 days ]
    any additional antibiotics prescribed due to infectious complications
  • Interventions for postoperative abscess [ Time Frame: 30 days ]
    drain placement by interventional radiology or peripherally inserted central catheter (PICC) placement for long term antibiotics
Original Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2017)
  • Postoperative Surgical Site Infection [ Time Frame: 30 days ]
    surgical site infections including superficial port site infection
  • Postoperative Readmission [ Time Frame: 30 days ]
    readmission within 30 days for any gastrointestinal complaints or infectious complications
  • Postoperative Antibiotic Charge [ Time Frame: 30 days ]
    any additional antibiotics prescribed due to infectious complications
  • Interventions for postoperative abscess [ Time Frame: 30 days ]
    drain placement by interventional radiology or PICC placement for long term antibiotics
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Two Different Antibiotics Versus One Antibiotic for Pediatric Perforated Appendicitis
Official Title  ICMJE Randomized Control Trial: Two Different Antibiotics Versus One Antibiotic for Pediatric Perforated Appendicitis
Brief Summary After appendix has been removed for perforated appendicitis, patients will receive postoperative antibiotics. In the last 5 years, the literature has transitioned from a 3 -drug therapy to 2-drug therapy. Now there is a recent literature suggesting a single-drug therapy may be safe and adequate. In fact, using zosyn (piperacillin-tazobactam) as a single-drug therapy, there are additional benefits of simplicity, compliance, and lower infectious complications. Currently surgeons are already using both 2-drug regimen (ceftriaxone/metronidazole) and single-drug regimen (zosyn) interchangeable as both are FDA approved and regulated antibiotics for intra-abdominal infection. There is a clear need to compare outcomes between these two options.
Detailed Description The diagnosis of perforated appendicitis will be documented intraoperatively with photos of extraluminal fecal contents or visible holes on the appendix. Patients will be randomized to 121 in each arm. Postoperative antibiotic therapy option will be decided based on blinded sequence model. 30 day postoperative follow up visit or calls will be made to assess and collect infectious complications.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Perforated Appendicitis
  • Postoperative Infection
Intervention  ICMJE Drug: piperacillin-tazobactam
Single drug therapy
Study Arms  ICMJE
  • No Intervention: 2-drug Therapy
    ceftriaxone/metronidazole
  • Experimental: 1-drug Therapy
    piperacillin-tazobactam
    Intervention: Drug: piperacillin-tazobactam
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 18, 2017)
242
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 22, 2020
Estimated Primary Completion Date December 22, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Postoperative Perforated Appendicitis (documented by intraoperative photo)
  • Postoperative Laparoscopic Appendectomy

Exclusion Criteria:

  • Nonperforated Gangrenous Appendicitis
  • Nonperforated Purulent Appendicitis
  • Open Appendectomy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Justin Lee, MD (602) 933-7007 jlee8@phoenixchildrens.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03289351
Other Study ID Numbers  ICMJE 17-011
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Phoenix Children's Hospital
Study Sponsor  ICMJE Phoenix Children's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Justin Lee, MD Phoenix Childrens Hospital
PRS Account Phoenix Children's Hospital
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP