MedTrace Logo

Two Different Antibiotics Versus One Antibiotic for Pediatric Perforated Appendicitis

NCT03289351 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2024-01-12

Study results available
· View outcomes & findings →

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.

Conditions

  • Perforated Appendicitis
  • Postoperative Infection

Interventions

DRUG

Piperacillin, Tazobactam Drug Combination

Single drug therapy

Sponsors & Collaborators

  • Phoenix Children's Hospital

    lead OTHER

Principal Investigators

  • Justin Lee, MD · Phoenix Childrens Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-22
Primary Completion
2021-11-17
Completion
2023-11-07
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03289351 on ClinicalTrials.gov