Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT01827358 · ClinicalTrials.gov registry record · Phase 2

Safety and Efficacy of Mupirocin in Eradicating Colonization With S. Aureus in Critically Ill Infants

A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 2
Development phase
155
Enrollment target

NCT01827358 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 155 participants.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT01827358, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 2
Development phase
155 participants
Enrollment target

Study Summary

The objective of this trial is 1) to evaluate the safety and clinical acceptability of a 5-day course of mupirocin applied every 8 hours (± 2 hours) to the nares, umbilical and perianal areas of infants residing in the ICU. 2) to examine the efficacy of mupirocin in eradicating SA colonization of infants in the ICU, defined as the absence of SA in cultures of the nares, umbilical, and perianal areas on day 8 (± 2) (primary decolonization) 3) to examine the efficacy of mupirocin in achieving persistent eradication of SA colonization among infants residing in the ICU,defined as the absence of SA in cultures of the nares, umbilical, and perianal areas. Duration is 36 months. Enrolled infants will continue to receive medical care as they otherwise would if they were not enrolled in the trial. The study will be powered with a primary endpoint with 126 participants. Enrollment may continue to 500 participants to power secondary and exploratory endpoints and assist design subsequent studies.

Interventions

  • DRUG Mupirocin calcium

Trial Details

FieldValue
Enrollment Target 155 participants
Start Date 2014-04-30
Est. Completion 2016-06-21
Phase Phase 2

What the Registry Record Tells You About NCT01827358

The ClinicalTrials.gov registry entry for NCT01827358 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 155 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Mupirocin calcium is the first listed.

NCT01827358 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01827358 about?

NCT01827358 is a clinical study titled "Safety and Efficacy of Mupirocin in Eradicating Colonization With S. Aureus in Critically Ill Infants". The objective of this trial is 1) to evaluate the safety and clinical acceptability of a 5-day course of mupirocin applied every 8 hours (± 2 hours) to the nares, umbilical and perianal areas of infants residing in the ICU. 2) to examine the efficacy of mupirocin in eradicating SA colonization of in...

What is the current status of trial NCT01827358?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 155 participants. The study started on 2014-04-30. Estimated completion is 2016-06-21.

What interventions are being tested in trial NCT01827358?

The interventions under investigation include: Mupirocin calcium (DRUG).

Who is sponsoring clinical trial NCT01827358?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

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

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.