Phase 4
N=162
Two Different Antibiotics Versus One Antibiotic for Pediatric Perforated Appendicitis
Perforated Appendicitis · Postoperative Infection
Bottom Line
View on ClinicalTrials.gov: NCT03289351 ↗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
| Outcome | Result | p-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
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.