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OpenTrials
Completed

NCT Number: NCT03289351

Two Different Antibiotics Versus One Antibiotic for Pediatric Perforated Appendicitis

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.

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Key information

Conditions

Perforated Appendicitis Appendicitis Cecal Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Infections Intestinal Diseases Intraabdominal Infections Postoperative Infection

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Phoenix Children's Hospital, Phoenix, Arizona, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Postoperative Perforated Appendicitis (documented by intraoperative photo)
  • Postoperative Laparoscopic Appendectomy

Exclusion criteria

  • Nonperforated Gangrenous Appendicitis
  • Nonperforated Purulent Appendicitis
  • Open Appendectomy

Treatment and study plan

Piperacillin, Tazobactam Drug Combination

Drug

Single drug therapy

Other names: piperacillin-tazobactam, Zosyn

Primary outcomes

  1. Number of Participants With a Postoperative Intra-abdominal Abscess

    Time frame: 30 days

    Intra-abdominal abscess documented by ultrasound or computerized tomography

Secondary outcomes

  1. Number of Participants With Postoperative Surgical Site Infection

    Time frame: 30 days

    surgical site infections including superficial port site infection

  2. Number of Participants With a Postoperative Readmission

    Time frame: 30 days

    readmission within 30 days for any gastrointestinal complaints or infectious complications

Sponsors and collaborators

Lead sponsor

Phoenix Children's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2023
First posted
Sep 20, 2017
Registry last updated
Jan 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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