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Phase 4 N=162 Randomized Treatment

Two Different Antibiotics Versus One Antibiotic for Pediatric Perforated Appendicitis

Perforated Appendicitis · Postoperative Infection

Enrolled (actual)
162
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcome: Primary: Number of Participants With a Postoperative Intra-abdominal Abscess — 19; 5 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Piperacillin, Tazobactam Drug Combination (Drug)
Age
Pediatric, Adult
Sex
All
Sponsor
Phoenix Children's Hospital
Primary completion
Nov 2021

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With a Postoperative Intra-abdominal Abscess
19; 5
SECONDARY
Number of Participants With Postoperative Surgical Site Infection
4; 4
SECONDARY
Number of Participants With a Postoperative Readmission
11; 4

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Nonperforated Gangrenous Appendicitis
  • Nonperforated Purulent Appendicitis
  • Open Appendectomy
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03289351). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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