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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 155 participants |
| Start Date | 2014-04-30 |
| Est. Completion | 2016-06-21 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗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.
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