Mupirocin for Decolonization of Infants in Neonatal Intensive Care Units.

Karen L Kotloff, Debbie-Ann T Shirley, C Buddy Creech, Sharon E Frey, Christopher J Harrison, Mary Staat, Evan J Anderson, Susan Dulkerian, Isaac P Thomsen, Mohamad Al-Hosni, Barbara A Pahud, David I Bernstein, Jumi Yi, Joshua E Petrikin, Beth Haberman, Kathy Stephens, Ina Stephens, Randolph E Oler, Tom M Conrad
Author Information
  1. Karen L Kotloff: Department of Pediatrics and kkotloff@som.umaryland.edu.
  2. Debbie-Ann T Shirley: Department of Pediatrics and.
  3. C Buddy Creech: Vanderbilt Vaccine Research Program, Department of Pediatrics, School of Medicine, Vanderbilt University, Nashville, Tennessee.
  4. Sharon E Frey: Departments of Medicine and.
  5. Christopher J Harrison: Children's Mercy Hospital, Kansas City, Missouri.
  6. Mary Staat: Department of Pediatrics, Cincinnati Children's Hospital Medical Center and University of Cincinnati, Cincinnati, Ohio.
  7. Evan J Anderson: Departments of Medicine and.
  8. Susan Dulkerian: Department of Pediatrics and.
  9. Isaac P Thomsen: Vanderbilt Vaccine Research Program, Department of Pediatrics, School of Medicine, Vanderbilt University, Nashville, Tennessee.
  10. Mohamad Al-Hosni: Pediatrics, Saint Louis University, St Louis, Missouri.
  11. Barbara A Pahud: Children's Mercy Hospital, Kansas City, Missouri.
  12. David I Bernstein: Department of Pediatrics, Cincinnati Children's Hospital Medical Center and University of Cincinnati, Cincinnati, Ohio.
  13. Jumi Yi: Pediatrics, School of Medicine, Emory University, Atlanta, Georgia; and.
  14. Joshua E Petrikin: Children's Mercy Hospital, Kansas City, Missouri.
  15. Beth Haberman: Department of Pediatrics, Cincinnati Children's Hospital Medical Center and University of Cincinnati, Cincinnati, Ohio.
  16. Kathy Stephens: Pediatrics, School of Medicine, Emory University, Atlanta, Georgia; and.
  17. Ina Stephens: Department of Pediatrics and.
  18. Randolph E Oler: Emmes Corporation, Rockville, Maryland.
  19. Tom M Conrad: Emmes Corporation, Rockville, Maryland.

Abstract

: media-1vid110.1542/5849573989001PEDS-VA_2018-1565 BACKGROUND AND OBJECTIVES: (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 ( < .001). Twenty-one of 46 (45.7%) treated infants were persistently decolonized compared with 1 of 48 (2.1%) controls ( < .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.

Associated Data

ClinicalTrials.gov | NCT01827358

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Grants

  1. HHSN272200800006C/NIAID NIH HHS
  2. HHSN272200800057C/NIAID NIH HHS
  3. HHSN272200800008C/NIAID NIH HHS
  4. HHSN272200800013C/NIAID NIH HHS
  5. HHSN272200800005C/NIAID NIH HHS
  6. HHSN272200800003C/NIAID NIH HHS

MeSH Term

Anti-Bacterial Agents
Female
Humans
Infant
Intensive Care Units, Neonatal
Male
Mupirocin
Staphylococcal Infections
Staphylococcus aureus

Chemicals

Anti-Bacterial Agents
Mupirocin

Word Cloud

Created with Highcharts 10.0.0infantsmupirocinSANICUdecolonization2Mupirocintreatedamongcolonizationnasalinfectionintranasaleradicating8randomlyassignedversusperianaldaybodysitesoccurred37%<001:media-1vid1101542/5849573989001PEDS-VA_2018-1565BACKGROUNDANDOBJECTIVES:secondleadingcauselate-onsetsepsismucosaand/orskinfrequentlyprecedesinvasivestrategiesapplicationattemptedpreventclinicaldatasupportingapproachlimitedconductedphasemulticenteropen-labelrandomizedtrialassesssafetyefficacyplustopicalcriticallyillMETHODS:April2014May2016<24monthsoldstudycentersunderwentserialscreeningColonizedmeteligibilitycriteriareceive5daysperiumbilicalareaseffectsprimarypersistent22threeassessedRESULTS:total155generallywelltoleratedrashesusuallymildsignificantlyoftenuntreatedPrimary6266939%644controlTwenty-one4645persistentlydecolonizedcompared1481%controlsCONCLUSIONS:ApplicationmultiplesafeefficaciouscarriagehoweverweeksmanyremainedhospitalizedbecamerecolonizedDecolonizationInfantsNeonatalIntensiveCareUnits

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