Safety and Efficacy of Mupirocin in Eradicating Colonization With S. Aureus in Critically Ill Infants
Condition: Staphylococcal Infection
MeSH terms: Staphylococcal Infections; Critical Illness
Intervention: Mupirocin calcium; Mupirocin calcium
Intervention description: Mupirocin calcium cream 2% applied topically to umbilicus and perianal area every 8 hours for 5 days, for a total of 15 applications; Mupirocin calcium ointment 2% will be applied intranasally every 8 hours for 5 days, for a total of 15 applications
Intervention MeSH terms: Calcium, Dietary; Mupirocin; Calcium
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Single Group Assignment
Enrollment: 155.0
Sex: All
Maximum age: 24 Months
Healthy volunteers: No
Keywords: antibacterial agent; children; colonisation; critically ill; infants; mupirocin; prevention; Staphylococcus aureus

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.
    

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