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Clinical Trial
. 2019 Jan;143(1):e20181565.
doi: 10.1542/peds.2018-1565.

Mupirocin for Staphylococcus aureus Decolonization of Infants in Neonatal Intensive Care Units

Karen L Kotloff  1   2 , Debbie-Ann T Shirley  3   2 , C Buddy Creech  4 , Sharon E Frey  5 , Christopher J Harrison  6 , Mary Staat  7 , Evan J Anderson  5   8 , Susan Dulkerian  3 , Isaac P Thomsen  4 , Mohamad Al-Hosni  9 , Barbara A Pahud  6 , David I Bernstein  7 , Jumi Yi  8 , Joshua E Petrikin  6 , Beth Haberman  7 , Kathy Stephens  8 , Ina Stephens  3   2 , Randolph E Oler Jr  10 , Tom M Conrad  10
Affiliations
Clinical Trial

Mupirocin for Staphylococcus aureus Decolonization of Infants in Neonatal Intensive Care Units

Karen L Kotloff et al. Pediatrics. 2019 Jan.

Abstract

: media-1vid110.1542/5849573989001PEDS-VA_2018-1565Video Abstract BACKGROUND AND OBJECTIVES: Staphylococcus aureus (SA) is the second leading cause of late-onset sepsis among infants in the NICU. Because colonization of nasal mucosa and/or skin frequently precedes invasive infection, decolonization strategies, such as mupirocin application, have been attempted to prevent clinical infection, but data supporting this approach in infants are limited. We conducted a phase 2 multicenter, open-label, randomized trial to assess the safety and efficacy of intranasal plus topical mupirocin in eradicating SA colonization in critically ill infants.

Methods: Between April 2014 and May 2016, infants <24 months old in the NICU at 8 study centers underwent serial screening for nasal SA. Colonized infants who met eligibility criteria were randomly assigned to receive 5 days of mupirocin versus no mupirocin to the intranasal, periumbilical, and perianal areas. Mupirocin effects on primary (day 8) and persistent (day 22) decolonization at all three body sites were assessed.

Results: A total of 155 infants were randomly assigned. Mupirocin was generally well tolerated, but rashes (usually mild and perianal) occurred significantly more often in treated versus untreated infants. Primary decolonization occurred in 62 of 66 (93.9%) treated infants and 3 of 64 (4.7%) control infants (P < .001). Twenty-one of 46 (45.7%) treated infants were persistently decolonized compared with 1 of 48 (2.1%) controls (P < .001).

Conclusions: Application of mupirocin to multiple body sites was safe and efficacious in eradicating SA carriage among infants in the NICU; however, after 2 to 3 weeks, many infants who remained hospitalized became recolonized.

Trial registration: ClinicalTrials.gov NCT01827358.

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Conflict of interest statement

POTENTIAL CONFLICT OF INTEREST: Dr Kotloff reports funds to conduct research on rotavirus vaccine in Africa from Merck, Sharpe, and Dohme; Dr Creech reports grant funding and personal consultation fees from GlaxoSmithKline and Pfizer for staphylococcal vaccine development; Dr Harrison reports grants from Merck and GlaxoSmithKline and consultation fees from Pfizer; Dr Pahud reports grant funding from Pfizer and consultation fees from Pfizer, Sanofi, and Sequiris; Dr Bernstein reports consultation fees from Merck and Takeda; Dr Anderson reports funds to conduct clinical research from MedImmune, Regeneron, Pfizer, and Novavax and personal fees from AbbVie; the other authors have indicated they have no potential conflicts of interest to disclose.

Figures

FIGURE 1
FIGURE 1
Study design. Day 1 began at the time the first dose of mupirocin was administered (treatment group) or at the time of randomization (control group) and ended at 11:59 pm of that same day. Subsequent days for patients and controls coincided with calendar days.
FIGURE 2
FIGURE 2
Subject enrollment. a Nasal swabs were collected from all admissions (universal screening) or from infants <24 months old who had an anticipated NICU stay of >14 days and lacked an exclusionary congenital anomaly (selective screening).
FIGURE 3
FIGURE 3
Maximum severity of solicited AEs during 1 to 7 days in infants treated with mupirocin and controls, who were not treated. a Apnea and pain and/or discomfort were collected within 3 to 5 minutes of mupirocin application but were not collected for controls.
See this image and copyright information in PMC

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