Status:
COMPLETED
Safety and Efficacy of Mupirocin in Eradicating Colonization With S. Aureus in Critically Ill Infants
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Staphylococcal Infection
Eligibility:
All Genders
Up to 24 years
Phase:
PHASE2
Brief 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 infan...
Detailed Description
This is a Phase 2, open label, multi-center, randomized trial to determine the safety and efficacy of mupirocin in eradicating colonization with Staphylococcus aureus (SA) and preventing the occurrenc...
Eligibility Criteria
Inclusion
- 1\. Currently admitted to a NICU or ICU at a participating site 2. Chronological age less than 24 months 3. Evidence of colonization with SA (MRSA or MSSA) based on a positive nasal surveillance culture. Randomization must occur within 7 days (168 hours) of when the site's laboratory reports the first SA positive nasal surveillance swab 4. The attending neonatologist/ intensivist anticipates that the infant will remain in the ICU for a minimum of 14 days after enrollment 5. Parent or legal guardian agrees that the infant will not participate in a research trial involving the administration of an investigational drug for 14 days following enrollment
Exclusion
- 1\. Receipt of an investigational drug as part of a research trial within the past 14 days 2. Previously enrolled and participated in this trial 3. Has an active or previous SA infection 4. Currently receiving topical or intranasal mupirocin 5. Has a rash in an area to which mupirocin will be directly applied 6. Has any of the following congenital abnormalities: --A congenital skin disorder (i.e. - epidermolysis bullosa, icthyosis) --An opened neural tube defect --Confirmed or suspected choanal atresia --Any of the following abdominal wall defects: wound dehiscence, gastroschisis, open abdominal wound (small abdominal wall defects such as ostomy sites or peritoneal drain sites are not exclusionary) 7. Is nasally intubated 8. Known hypersensitivity to the trial product or its constituents 9. Known or suspected immune deficiency. Infants born to HIV-seropositive mothers with the following risk factors for intrapartum transmission will not be eligible to participate: --Mother's most recent viral load within the past 3 months was \> 1,000 copies/ml or --Mother's viral load is not known or has has not been measured in the past 3 months. 10. Any other condition(s) that in the opinion of the investigator would jeopardize the safety or rights of a participant or would render the participant unable to comply with the protocol
Key Trial Info
Start Date :
April 30 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 21 2016
Estimated Enrollment :
155 Patients enrolled
Trial Details
Trial ID
NCT01827358
Start Date
April 30 2014
End Date
June 21 2016
Last Update
July 7 2017
Active Locations (6)
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1
Emory University Hospital Midtown - Neonatal Intensive Care Unit
Atlanta, Georgia, United States, 30308-2208
2
University of Maryland Medical Center - Children's Hospital - Neonatal Intensive Care Unit
Baltimore, Maryland, United States, 21201-1595
3
Children's Mercy Hospital and Clinics - Infectious Diseases
Kansas City, Missouri, United States, 64108-4619
4
Saint Louis University School of Medicine - Cardinal Glennon Children's Medical Center - NICU
St Louis, Missouri, United States, 63104-1003