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NCT06002607 · ClinicalTrials.gov registry record

Shorter Versus Extended Course of Antibiotic Therapy for Necrotizing Soft Tissue Infections

A clinical trial of Necrotizing Soft Tissue Infection, sponsored by University of California, Irvine.

Recruiting
Registry status
50
Enrollment target
1
Study location

NCT06002607: Recruiting study of Necrotizing Soft Tissue Infection, sponsored by University of California, Irvine.

NCT06002607 is a study of Necrotizing Soft Tissue Infection that is actively recruiting participants, run by University of California, Irvine. The registered enrollment target is 50 participants, below the 331-participant average among 3 other Necrotizing Soft Tissue Infection trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06002607, a study of Necrotizing Soft Tissue Infection, is actively recruiting participants, sponsored by University of California, Irvine.

RECRUITING
Registry status
50 participants
Enrollment target
1
Study location

Study Summary

Necrotizing soft tissue infection (NSTI) is a devastating disease that results in a high rate of in-hospital complications and despite advances in critical care, wound care, and early intervention, NSTI continues to be associated with a mortality rate of nearly 30%. The antibiotics used in this treatment are Clindamycin, Vancomycin, Piperacillin Tazobactam; these antibiotics may be administered combined or individually, based on individualized patient treatment. Although one of the tenets of management for NSTI is early broad-spectrum intravenous antibiotics (listed above), the duration of antibiotics needed is not well defined. Currently, there exists wide variation in the duration of antibiotics for NSTI ranging between 2-16 days. The objective of this study is to evaluate the safety of a shorter course of antibiotics hypothesizing that a short duration of antibiotics for 48-hours after source-control is achieved will have similar risk of morbidity and mortality compared to a 7-day course of antibiotics post source control. A second aim of this study will be to identify if serum procalcitonin levels/ratio correspond to resolution of systemic infection in patients with NSTI.

Primary Outcome

In-hospital complications

Interventions

  • OTHER Antibiotic duration (short course)
  • OTHER Antibiotic duration (extended course)

Study Locations (1)

California

  • University of California Irvine Medical Center - Orange

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2023-12-28
Est. Completion 2026-12-01
University of California, Irvine

368 total trials

What NCT06002607 shows while recruiting

NCT06002607 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 331-participant average among 3 other Necrotizing Soft Tissue Infection trials with a reported enrollment target (85% lower).

The record links to 1 condition, with Necrotizing Soft Tissue Infection appearing as the primary indexed condition, and to 2 interventions - of which Antibiotic duration (short course) is the first listed.

NCT06002607 reports a single indexed study location in California.

Frequently Asked Questions

What is clinical trial NCT06002607 about?

NCT06002607 is a clinical study titled "Shorter Versus Extended Course of Antibiotic Therapy for Necrotizing Soft Tissue Infections". Necrotizing soft tissue infection (NSTI) is a devastating disease that results in a high rate of in-hospital complications and despite advances in critical care, wound care, and early intervention, NSTI continues to be associated with a mortality rate of nearly 30%. The antibiotics used in this trea...

What is the current status of trial NCT06002607?

This trial is currently recruiting. The enrollment target is 50 participants. The study started on 2023-12-28. Estimated completion is 2026-12-01.

What conditions does trial NCT06002607 study?

This clinical trial studies the following conditions: Necrotizing Soft Tissue Infection.

What interventions are being tested in trial NCT06002607?

The interventions under investigation include: Antibiotic duration (short course) (OTHER), Antibiotic duration (extended course) (OTHER).

Who is sponsoring clinical trial NCT06002607?

This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06002607 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT06002607, the US trial registry maintained by the National Library of Medicine. NCT06002607 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.