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NCT03231228 · ClinicalTrials.gov registry record · Phase 4

Safety of 1 g and 2 g of Cefazolin in Pediatric Subjects

A Phase 4 study, sponsored by B. Braun Medical.

Terminated
Registry status
Phase 4
Development phase
61
Enrollment target

NCT03231228: Clinical Trial Phase 4 study, sponsored by B. Braun Medical.

NCT03231228 is a Phase 4 study that was terminated before completion, run by B. Braun Medical. The registered enrollment target is 61 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03231228, a Phase 4 study, was terminated before completion, sponsored by B. Braun Medical.

TERMINATED
Registry status
Phase 4
Development phase
61 participants
Enrollment target

Study Summary

This is a Phase 4, open-label, single-dose, parallel-group, multicenter, safety study of cefazolin (1 g or 2 g) in pediatric subjects between 10 and 17 years of age (inclusive) scheduled for surgery.

Primary Outcome

Safety will be assessed by monitoring adverse events (AEs), physical examinations, vital signs, ECGs, and clinical laboratory results.

Interventions

  • DRUG Cefazolin 1 g Infusion
  • DRUG Cefazolin 2 g Infusion

Trial Details

FieldValue
Enrollment Target 61 participants
Start Date 2017-11-20
Est. Completion 2019-07-31
Phase Phase 4
B. Braun Medical

8 total trials

Why NCT03231228 stopped before completion

NCT03231228 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower).

The record links to 0 conditions, and to 2 interventions - of which Cefazolin 1 g Infusion is the first listed.

NCT03231228 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03231228 about?

NCT03231228 is a clinical study titled "Safety of 1 g and 2 g of Cefazolin in Pediatric Subjects". This is a Phase 4, open-label, single-dose, parallel-group, multicenter, safety study of cefazolin (1 g or 2 g) in pediatric subjects between 10 and 17 years of age (inclusive) scheduled for surgery.

What is the current status of trial NCT03231228?

This trial is currently terminated. It is a Phase 4 study. The enrollment target is 61 participants. The study started on 2017-11-20. Estimated completion is 2019-07-31.

What interventions are being tested in trial NCT03231228?

The interventions under investigation include: Cefazolin 1 g Infusion (DRUG), Cefazolin 2 g Infusion (DRUG).

Who is sponsoring clinical trial NCT03231228?

This trial is sponsored by B. Braun Medical, which has 8 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03231228's enrollment target sits among peer trials

61 1119th of 2000 higher than 876 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 NCT03231228, the US trial registry maintained by the National Library of Medicine. NCT03231228 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.