CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 162 enrolled
Drug / intervention
Piperacillin, Tazobactam Drug Combinationdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03289351
NCT03289351Phase 4Completed

Randomized Control Trial: Two Different Antibiotics Versus One Antibiotic for Pediatric Perforated Appendicitis

Phoenix Children's Hospital·interventional·Posted Sep 20, 2017·Updated Jan 12, 2024

In Brief

A Phase 4 clinical trial evaluating Piperacillin, Tazobactam Drug Combination for Perforated Appendicitis and Postoperative Infection. Completed, enrolled 162 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedSep 20, 2017
Enrollment StartMay 22, 2017
Primary CompletionNov 17, 2021
Study CompletionNov 7, 2023
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 8.8 years ago

Interventions

Piperacillin, Tazobactam Drug Combinationdrug

Single drug therapy