NCT03289351

Two Different Antibiotics Versus One Antibiotic for Pediatric Perforated Appendicitis

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 162 (actual)
• Sponsor: Phoenix Children's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

The diagnosis of perforated appendicitis will be documented intraoperatively with photos of extraluminal fecal contents or visible holes on the appendix. Patients will be randomized to 121 in each arm. Postoperative antibiotic therapy option will be decided based on blinded sequence model. 30 day postoperative follow up visit or calls will be made to assess and collect infectious complications.

Conditions

• Perforated Appendicitis
• Postoperative Infection

Interventions

Type	Name	Description
DRUG	Piperacillin, Tazobactam Drug Combination	Single drug therapy

Timeline

• Start date: 2017-05-22
• Primary completion: 2021-11-17
• Completion: 2023-11-07
• First posted: 2017-09-20
• Last updated: 2024-01-12
• Results posted: 2024-01-12

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study