drugset / Trial / NCT03289351

Two Different Antibiotics Versus One Antibiotic for Pediatric Perforated Appendicitis

NCT03289351

Phase 4 Completed 162 enrolled Phoenix Children's Hospital
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2017-05-22
Primary completion
2021-11-17
Completion
2023-11-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Piperacillin Small molecule
Subject Tazobactam Small molecule

Indications