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Livestock Contact and MRSA in Rural Areas

21. mai 2020 oppdatert av: National Cancer Institute (NCI)

Epidemiology of Rural MRSA : Is Livestock Contact a Risk Factor?

Background:

- MRSA is a type of bacteria that causes serious health problems. It can cause severe infections and is difficult to treat. MRSA has been found in a high number of people who work with some kinds of livestock, such as pigs. Researchers want to study people in rural areas, where more people work with or around livestock. They want to see if MRSA is more common or causes more serious infections in these areas.

Objectives:

- To look at the relationship between livestock handling (especially pigs) and MRSA bacteria in people in rural areas.

Eligibility:

  • Participants in the Agricultural Health Study in Iowa, including those who are exposed to livestock.
  • Healthy volunteers who are not exposed to livestock.

Design:

  • This study requires an initial visit and monthly follow-up surveys for 18 months.
  • At the first visit, participants will have throat and nose swabs to collect cell and bacteria samples. They will also complete a questionnaire about their health habits. Other questions will ask about any work that brings them into contact with livestock like cows, pigs, or chickens.
  • Every month for the next 17 months, participants will complete another questionnaire to record any changes in their health and livestock contact information. They will also collect throat and nose swabs. They will send the questionnaires and the swabs to the study researchers.
  • Participants will be paid for the first visit and for every monthly survey and swab collection they return.
  • No treatment will be given as part of this protocol.

Studieoversikt

Status

Fullført

Detaljert beskrivelse

The goal of this study is to understand the epidemiology of antibiotic-resistant S. aureus, including methicillin resistant S. aureus (MRSA), outside of the hospital environment. Our objective is to characterize the epidemiology of S. aureus in the rural community, focusing on persons who have contact with livestock. We will achieve this by carrying out two parallel prospective cohort studies in Iowa, examining 1) individuals enrolled in the Agricultural Health Study, including those who raise swine; and 2) a matched population-based group with no livestock exposure. We will partner with the state s microbiological diagnostic laboratories in order to collect isolates from the symptomatic S. aureus infections. Our central hypothesis is that individuals working in close proximity to livestock and poultry are at risk of occupational exposure to MRSA. We further hypothesize that farmers in contact with livestock (swine in particular) will be more likely to be colonized with swine-associated S. aureus strains than are individuals without contact. Finally, we expect to see both typical human strains of S. aureus (including USA300) as well as animal-associated strains (such as ST398) causing infections in Iowans. Our rationale is that successful completion will provide opportunities to institute an early warning system to evaluate emerging S. aureus strains, allowing for potential interventions prior to widespread dissemination in the human population. We will test our central hypothesis and accomplish the objective of this application by pursuing the following specific aims:

  1. Establish the prevalence, molecular subtypes, and antibiotic resistance profiles of S. aureus in populations of rural Iowans, and determine risk factors for colonization. We hypothesize that individuals in contact with swine will be more likely to carry MRSA than individuals lacking such exposure; that swine workers will more frequently be colonized with swine-associated strains such as ST398; and that S. aureus isolates collected from livestock farmers will more frequently demonstrate resistance to antibiotics including methicillin and tetracyclines than isolates collected from individuals lacking livestock exposure.
  2. Determine the incidence and molecular epidemiology of symptomatic S. aureus infections in rural Iowans. We hypothesize that symptomatic infections will be uncommon in our cohort relative to colonization, and that the majority of such infections will be skin and soft tissue infections. We further hypothesize that the majority of infections in our cohorts and elsewhere in the state will be caused by common strains (including USA300), but that some infections will also be caused by animal-associated strains, including ST398.

Studietype

Observasjonsmessig

Registrering (Faktiske)

1342

Kontakter og plasseringer

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

Studiesteder

    • Iowa
      • Coralville, Iowa, Forente stater, 52241
        • University of Iowa

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

6 måneder til 100 år (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Individuals enrolled in the Agricultural Health Study, including those who raise swine; and a matched population-based group with no livestock exposure.

Beskrivelse

  • INCLUSION CRITERIA:
  • Cohort A: Participant or child of participant in the Agricultural Health Study
  • Cohort B: Resident of Iowa

EXCLUSION CRITERIA:

  • Cohort A: Age <8 months
  • Cohort B: Age <8 months

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
AHS cohort
population of S. aureus asymptomatic rural Iowans
Non-AHS group
symptomatic S. aureus infections in rural Iowans.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Epidemiology of MRSA in AHS cohort
Tidsramme: ongoing
Establish the prevalence, molecular subtypes, and antibiotic resistance profiles of S. aureus in populations of rural Iowans, and determine risk factors for colonization.
ongoing
Epidemiology of MRSA in matched, population-based non-AHS group
Tidsramme: ongoing
Determine the incidence and molecular epidemiology of symptomatic S. aureus infections in rural Iowans.
ongoing

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Publikasjoner og nyttige lenker

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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 (Faktiske)

1. juni 2011

Primær fullføring (Faktiske)

21. mars 2016

Studiet fullført (Faktiske)

21. mai 2020

Datoer for studieregistrering

Først innsendt

16. juni 2011

Først innsendt som oppfylte QC-kriteriene

16. juni 2011

Først lagt ut (Anslag)

17. juni 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. mai 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. mai 2020

Sist bekreftet

1. mai 2020

Mer informasjon

Begreper knyttet til denne studien

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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