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Two Different Antibiotics Versus One Antibiotic for Pediatric Perforated Appendicitis

Sponsor
Phoenix Children's Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03289351
Collaborator
(none)
162
Enrollment
2
Locations
2
Arms
68.6
Anticipated Duration (Months)
81
Patients Per Site
1.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Piperacillin, Tazobactam Drug Combination
 Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
162 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Randomized Control Trial: Two Different Antibiotics Versus One Antibiotic for Pediatric Perforated Appendicitis
Actual Study Start Date :
May 22, 2017
Actual Primary Completion Date :
Feb 8, 2022
Anticipated Study Completion Date :
Feb 8, 2023

Arms and Interventions

Arm Intervention/Treatment
No Intervention: 2-drug Therapy

ceftriaxone/metronidazole
Experimental: 1-drug Therapy

piperacillin-tazobactam

Drug: Piperacillin, Tazobactam Drug Combination
Single drug therapy
Other Names:
  • piperacillin-tazobactam
  • Zosyn

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Postoperative Intra-abdominal Abscess [30 days]

      Intra-abdominal abscess documented by ultrasound or computerized tomography

    Secondary Outcome Measures

    1. Postoperative Surgical Site Infection [30 days]

      surgical site infections including superficial port site infection

    2. Postoperative Readmission [30 days]

      readmission within 30 days for any gastrointestinal complaints or infectious complications

    3. Postoperative Antibiotic Charge [30 days]

      any additional antibiotics prescribed due to infectious complications

    4. Interventions for postoperative abscess [30 days]

      drain placement by interventional radiology or peripherally inserted central catheter (PICC) placement for long term antibiotics

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Postoperative Perforated Appendicitis (documented by intraoperative photo)

    • Postoperative Laparoscopic Appendectomy

    Exclusion Criteria:

    • Nonperforated Gangrenous Appendicitis

    • Nonperforated Purulent Appendicitis

    • Open Appendectomy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Phoenix Children's Hospital Phoenix Arizona United States 85016
    2 Children's Mercy Hospital Kansas City Missouri United States 64108

    Sponsors and Collaborators

    • Phoenix Children's Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Phoenix Children's Hospital
    ClinicalTrials.gov Identifier:
    NCT03289351
    Other Study ID Numbers:
    • 17-011
    First Posted:
    Sep 20, 2017
    Last Update Posted:
    Apr 29, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Appendicitis
    Tazobactam
    Piperacillin
    Piperacillin, Tazobactam Drug Combination

    Study Results

    No Results Posted as of Apr 29, 2022