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Prevention of Recurrent Infections Caused by Community Acquired Staphylococcus Aureus (CA-SA) in Children

19. september 2016 oppdatert av: Sheldon Kaplan, Baylor College of Medicine

Prevention of Recurrent Infections Caused by Community-Acquired Staphylococcus in Children 3 Months to 18 Years

The primary purpose of this study is to determine if adding bleach baths to routine ways for prevention of Staph infections is helpful. The amount added is a very weak amount. This would provide a relatively inexpensive method to help prevent recurrent skin infections caused by the Staph germ. The investigators will also be studying how often Staphylococcus aureus lives in the nose, throat, and groin area.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

In many areas of the United States, methicillin-resistant Staphylococcus aureus is now an established community pathogen (CA-MRSA). At Texas Children's Hospital (TCH), about 75% of S. aureus isolates recovered from healthy children with infections are CA-MRSA and > 90% of the CA-MRSA isolates are related to one clone, USA300, which also predominates throughout the U.S. From 8/05 to 7/06, 1400 children with CA-MRSA infection were seen at TCH; 60% were admitted to the hospital. Why the USA300 clone is so successful in spreading throughout the community is unclear, but it does harbor a unique set of genes not found in other S. aureus clones. The anterior nose in the most common area of the body colonized with S. aureus but it is not known if this is the primary site for colonization by CA-MRSA USA300 clone.

Approximately 3.5% of children at TCH have a proven recurrence of S. aureus infection within 12 months; we believe this is a minimal estimate and that overall at least 10% of children have recurrences. There is no consensus on the best strategies for preventing recurrent S. aureus infections or spread of S. aureus among family members. At TCH, in addition to routine preventative measures, we often recommend for the patients to take a bath at least twice a week in water to which one teaspoon of household bleach (Clorox) has been added per gallon of water. Anecdotally this approach has decreased the recurrence rate of S. aureus infections, but this common strategy among dermatologists has not been formally evaluated and is thus controversial.

Objectives

The primary objective is to test the hypothesis that in children who have a community-acquired Staphylococcus aureus (CA-SA) infection, sodium hypochlorite baths (Clorox) are a safe and effective component of a prevention strategy that will reduce recurrent medically attended skin and soft tissue infection (MA-SSI).

Specific Aims

  1. Determine the recurrence rate (over a 12 month period) of medically attended skin and soft tissue infection visits in children initially evaluated in the TCH Emergency Center for whom a 3 month prevention strategy includes taking a bath twice a week in water to which sodium hypochlorite (Clorox) has been added and the recurrence rate in children for whom a similar prevention strategy has been recommended but without the bath component.
  2. Determine the recurrence rate (over a 12 month period) of skin and soft tissue infection caused by CA-S. aureus in children for whom a 3-month prevention strategy includes taking a bath twice a week in water to which sodium hypochlorite (Clorox) has been added and the recurrence rate in children for whom a similar prevention strategy has been recommended but without the bath component.
  3. Determine the + rates of S. aureus colonization of the anterior nares, pharynx, and groin for children being evaluated in the emergency center of Texas Children's Hospital (TCH) or admitted to TCH with suspected S. aureus infections.

Studietype

Intervensjonell

Registrering (Faktiske)

987

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Texas
      • Houston, Texas, Forente stater, 77030
        • Baylor College of Medicine
      • Houston, Texas, Forente stater, 77030
        • Texas Children's Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

3 måneder til 18 år (Barn, Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Otherwise healthy children 3 months to 18 years seen in the emergency center of Texas Children's Hospital with suspected CA-S. aureus infections
  • Have a lesion which can be cultured (abscess or cellulitis with drainage, invasive infections)
  • Can be evaluated and treated in the emergency center and be followed as outpatients
  • Can be admitted to the hospital

Exclusion Criteria:

  • Children less than 3 months old or greater than 18 years
  • Immune deficiency or underlying condition other than reactive airway disease or simple eczema which is not being followed by a dermatologist
  • Patient has a history of 2 or more previous skin or soft tissue infections
  • Children with one previous episode whose family may have already employed the sodium hypochlorite baths
  • Families without a bathtub or running water
  • Families without a phone or primary care physician
  • Families unable or unwilling to comply with the prevention measures
  • Hypersensitivity to sodium hypochlorite

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Routine Measures
Fremgangsmåte: Routine Measures Group
Cultures will be obtained from the anterior nares of the nose, the throat and the groin using separate culturette swabs. S. aureus isolates will be identified and antibiotic susceptibility determined. Isolates will subsequently undergo testing for susceptibility to methicillin to determine if the isolate is an MSSA or MRSA strain. All patients and parents will be instructed orally and provided written instructions about routine measures employed for the prevention of S. aureus skin infections. Please see supplemental material from the publication Randomized Trial of "Bleach Baths" plus Routine Hygienic Measures vs Routine Hygienic Measures Alone for Prevention of Recurrent Infections Clinical Infectious Diseases 2014;58:679-682 for the details regarding routine measures.
Andre navn:
  • Prevention of Infections Caused by CA-SA in Children.
Eksperimentell: Bleach Baths
Fremgangsmåte: Bleach Bath Group (Bleach plus routine measures)
Cultures will be obtained from the anterior nares of the nose, the throat and the groin using culturette swabs. S. aureus isolates will be identified and antibiotic susceptibility determined. Isolates will subsequently undergo testing for susceptibility to methicillin to determine if the isolate is an MSSA or MRSA strain. Patients and parents will be instructed orally and provided written instructions about routine measures employed for the prevention of S. aureus skin infections. Patients will be given further oral and written instructions regarding clorox baths. Please see supplemental material from the publication Randomized Trial of "Bleach Baths" plus Routine Hygienic Measures vs Routine Hygienic Measures Alone for Prevention of Recurrent Infections Clinical Infectious Diseases 2014;58:679-682 for the details regarding instructions for bleach baths.
Andre navn:
  • Clorox Baths

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Medically Attended Skin and Soft Tissue Infections (MA-SSI)
Tidsramme: From time of enrollment until the first MA-SSI or 12 months following enrollment, whichever came first.
Medically attended skin and soft tissue infections (MA-SSI) which is defined as a skin or soft tissue infection that has been evaluated and treated by a medical professional in an office, clinic, urgent care or emergency center setting.
From time of enrollment until the first MA-SSI or 12 months following enrollment, whichever came first.

Samarbeidspartnere og etterforskere

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Sponsor

Baylor College of Medicine

Etterforskere

  • Hovedetterforsker: Sheldon L Kaplan, MD, Baylor College of Medicine

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juni 2009

Primær fullføring (Faktiske)

1. januar 2012

Studiet fullført (Faktiske)

1. januar 2013

Datoer for studieregistrering

Først innsendt

11. mai 2009

Først innsendt som oppfylte QC-kriteriene

12. mai 2009

Først lagt ut (Anslag)

13. mai 2009

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

6. november 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

19. september 2016

Sist bekreftet

1. september 2016

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • Thrasher21631

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