Safety and Efficacy of Mupirocin in Eradicating Colonization With S. Aureus in Critically Ill Infants
Public ClinicalTrials.gov record NCT01827358. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Safety and Efficacy of Intranasal and Topical Mupirocin in Eradicating Colonization With Staphylococcus Aureus (SA) in Critically Ill Infants - a Phase 2, Multi-Center, Open Label, Randomized Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01827358
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 155 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- Up to 24 Months
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 29, 2014
- Primary completion
- Jun 6, 2016
- Completion
- Jun 20, 2016
- Last update posted
- Jul 6, 2017
2014 – 2016
United States locations
- U.S. sites
- 6
- U.S. states
- 5
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Emory University Hospital Midtown - Neonatal Intensive Care Unit | Atlanta | Georgia | 30308-2208 | — |
| University of Maryland Medical Center - Children's Hospital - Neonatal Intensive Care Unit | Baltimore | Maryland | 21201-1595 | — |
| Children's Mercy Hospital and Clinics - Infectious Diseases | Kansas City | Missouri | 64108-4619 | — |
| Saint Louis University School of Medicine - Cardinal Glennon Children's Medical Center - NICU | St Louis | Missouri | 63104-1003 | — |
| Cincinnati Children's Hospital Medical Center - Infectious Diseases | Cincinnati | Ohio | 45229-3039 | — |
| Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center | Nashville | Tennessee | 37232-2573 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01827358, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 6, 2017 · Synced Sep 10, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01827358 live on ClinicalTrials.gov.