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NCT03289351 · ClinicalTrials.gov registry record · Phase 4

Two Different Antibiotics Versus One Antibiotic for Pediatric Perforated Appendicitis

A Phase 4 study, sponsored by Phoenix Children's Hospital.

Completed
Registry status
Phase 4
Development phase
162
Enrollment target

NCT03289351: Completed Phase 4 study, sponsored by Phoenix Children's Hospital.

NCT03289351 is a Phase 4 study that has completed, run by Phoenix Children's Hospital. The registered enrollment target is 162 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03289351, a Phase 4 study, has completed, sponsored by Phoenix Children's Hospital.

COMPLETED
Registry status
Phase 4
Development phase
162 participants
Enrollment target

Study 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.

Primary Outcome

Intra-abdominal abscess documented by ultrasound or computerized tomography

Interventions

  • DRUG Piperacillin, Tazobactam Drug Combination

Trial Details

FieldValue
Enrollment Target 162 participants
Start Date 2017-05-22
Est. Completion 2023-11-07
Phase Phase 4
Phoenix Children's Hospital

26 total trials

What the finished NCT03289351 record still lists

NCT03289351 is an interventional study that assigns participants to a tested intervention. The registered 162 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (69% lower).

The record links to 0 conditions, and to 1 intervention - of which Piperacillin, Tazobactam Drug Combination is the first listed.

NCT03289351 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03289351 about?

NCT03289351 is a clinical study titled "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 ...

What is the current status of trial NCT03289351?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 162 participants. The study started on 2017-05-22. Estimated completion is 2023-11-07.

What interventions are being tested in trial NCT03289351?

The interventions under investigation include: Piperacillin, Tazobactam Drug Combination (DRUG).

Who is sponsoring clinical trial NCT03289351?

This trial is sponsored by Phoenix Children's Hospital, which has 26 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03289351's enrollment target sits among peer trials

162 503rd of 2000 higher than 1,495 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03289351, the US trial registry maintained by the National Library of Medicine. NCT03289351 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.