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

19 settembre 2016 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

987

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Texas
      • Houston, Texas, Stati Uniti, 77030
        • Baylor College of Medicine
      • Houston, Texas, Stati Uniti, 77030
        • Texas Children's Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 3 mesi a 18 anni (Bambino, Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Routine Measures
Procedura: 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.
Altri nomi:
  • Prevention of Infections Caused by CA-SA in Children.
Sperimentale: Bleach Baths
Procedura: 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.
Altri nomi:
  • Clorox Baths

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Medically Attended Skin and Soft Tissue Infections (MA-SSI)
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Baylor College of Medicine

Investigatori

  • Investigatore principale: Sheldon L Kaplan, MD, Baylor College of Medicine

Pubblicazioni e link utili

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Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 giugno 2009

Completamento primario (Effettivo)

1 gennaio 2012

Completamento dello studio (Effettivo)

1 gennaio 2013

Date di iscrizione allo studio

Primo inviato

11 maggio 2009

Primo inviato che soddisfa i criteri di controllo qualità

12 maggio 2009

Primo Inserito (Stima)

13 maggio 2009

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

6 novembre 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

19 settembre 2016

Ultimo verificato

1 settembre 2016

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • Thrasher21631

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Prove cliniche su Routine Measures Group

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