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NCT01549613 · ClinicalTrials.gov registry record · Phase 4

Evaluation of Daptomycin for the Emergency Department Treatment of Complicated Skin and Skin Structure Infections

A Phase 4 study of Cellulitis and Skin Infections, sponsored by University of Cincinnati.

Completed
Registry status
Phase 4
Development phase
104
Enrollment target
1
Study location

NCT01549613 is a Phase 4 study of Cellulitis and Skin Infections that has completed, run by University of Cincinnati. The registered enrollment target is 104 participants, below the 561-participant average among 11 other Cellulitis trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01549613, a Phase 4 study of Cellulitis and Skin Infections, has completed, sponsored by University of Cincinnati.

COMPLETED
Registry status
Phase 4
Development phase
104 participants
Enrollment target
1
Study location

Study Summary

This is a prospective, randomized clinical trial comparing daptomycin to vancomycin in the Emergency Department (ED) treatment of complicated skin and skin structure infection in the Rapid Diagnosis and Treatment Center (RDTC). In brief, a convenience sample of patients who are admitted to the RDTC cellulitis protocol in the ED will be randomized to either vancomycin, which is currently an accepted care standard in the RDTC cellulitis protocol, or daptomycin, which is the experimental treatment in this study. The primary hypothesis is that daptomycin treatment is as efficacious as standard therapy in the treatment of ED cellulitis.

Interventions

  • DRUG Vancomycin
  • DRUG Daptomycin

Study Locations (1)

Ohio

  • University of Cincinnati, Dept. of Emergency Medicine - Cincinnati

Trial Details

FieldValue
Enrollment Target 104 participants
Start Date 2012-05
Est. Completion 2013-07
Phase Phase 4

Sponsor

University of Cincinnati

245 total trials

What the Registry Record Tells You About NCT01549613

The ClinicalTrials.gov registry entry for NCT01549613 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 104 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 561-participant average among 11 other Cellulitis trials with a reported enrollment target (81% lower). The listed sponsor is University of Cincinnati, which has 245 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Cellulitis appearing as the primary indexed condition, and to 2 interventions - of which Vancomycin is the first listed.

NCT01549613 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.

Frequently Asked Questions

What is clinical trial NCT01549613 about?

NCT01549613 is a clinical study titled "Evaluation of Daptomycin for the Emergency Department Treatment of Complicated Skin and Skin Structure Infections". This is a prospective, randomized clinical trial comparing daptomycin to vancomycin in the Emergency Department (ED) treatment of complicated skin and skin structure infection in the Rapid Diagnosis and Treatment Center (RDTC). In brief, a convenience sample of patients who are admitted to the RDTC ...

What is the current status of trial NCT01549613?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 104 participants. The study started on 2012-05. Estimated completion is 2013-07.

What conditions does trial NCT01549613 study?

This clinical trial studies the following conditions: Cellulitis, Skin Infections.

What interventions are being tested in trial NCT01549613?

The interventions under investigation include: Vancomycin (DRUG), Daptomycin (DRUG).

Who is sponsoring clinical trial NCT01549613?

This trial is sponsored by University of Cincinnati, which has 245 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01549613 being conducted?

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

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.