Two Different Antibiotics Versus One Antibiotic for Pediatric Perforated Appendicitis

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

Tracking Information

• First Submitted Date: September 18, 2017
• First Posted Date: September 20, 2017
• Last Update Posted Date: August 30, 2019
• Actual Study Start Date: May 22, 2017
• Estimated Primary Completion Date: December 22, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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 (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: Two Different Antibiotics Versus One Antibiotic for Pediatric Perforated Appendicitis
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Perforated Appendicitis
• Postoperative Infection

Intervention

Drug: piperacillin-tazobactam

Single drug therapy

Study Arms

• No Intervention: 2-drug Therapy
  ceftriaxone/metronidazole
• Experimental: 1-drug Therapy
  piperacillin-tazobactam
  Intervention: Drug: piperacillin-tazobactam

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 18, 2017): 242
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 22, 2020
• Estimated Primary Completion Date: December 22, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• Nonperforated Gangrenous Appendicitis
• Nonperforated Purulent Appendicitis
• Open Appendectomy

Sex/Gender

• Sexes Eligible for Study: All

• Ages: up to 18 Years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Justin Lee, MD; (602) 933-7007; jlee8@phoenixchildrens.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03289351
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: Phoenix Children's Hospital
• Study Sponsor: Phoenix Children's Hospital
• Collaborators: Not Provided

Investigators

• Principal Investigator: Justin Lee, MD; Phoenix Childrens Hospital

• PRS Account: Phoenix Children's Hospital
• Verification Date: August 2019