Safety and Efficacy of Mupirocin in Eradicating Colonization With S. Aureus in Critically Ill Infants
Staphylococcal Infection
About this trial
This is an interventional prevention trial for Staphylococcal Infection focused on measuring antibacterial agent, children, colonisation, critically ill, infants, mupirocin, prevention, Staphylococcus aureus
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Sites / Locations
- Emory University Hospital Midtown - Neonatal Intensive Care Unit
- University of Maryland Medical Center - Children's Hospital - Neonatal Intensive Care Unit
- Children's Mercy Hospital and Clinics - Infectious Diseases
- Saint Louis University School of Medicine - Cardinal Glennon Children's Medical Center - NICU
- Cincinnati Children's Hospital Medical Center - Infectious Diseases
- Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Group 1
Group 2
Subjects receive a 5-day course of mupirocin calcium ointment 2 % 20 mg intranasally applied every 8 hours and a topical skin application (umbilical and perianal area) of mupirocin calcium cream 2% 20 mg applied every 8 hours for a total of 15 doses
No treatment