NCT01375621

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,342

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 17, 2011

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2016

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 21, 2020

Completed
Last Updated

May 22, 2020

Status Verified

May 1, 2020

Enrollment Period

4.8 years

First QC Date

June 16, 2011

Last Update Submit

May 21, 2020

Conditions

Staphylococcus Aureus Infection

Keywords

FarmingAntibiotic ResistantBacteria

Outcome Measures

Primary Outcomes (2)

  • Epidemiology of MRSA in AHS cohort

    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

    Determine the incidence and molecular epidemiology of symptomatic S. aureus infections in rural Iowans.

    ongoing

Study Arms (2)

AHS cohort

population of S. aureus asymptomatic rural Iowans

Non-AHS group

symptomatic S. aureus infections in rural Iowans.

Eligibility Criteria

Age6 Months - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iowa

Coralville, Iowa, 52241, United States

Location

Related Publications (3)

  • Graham PL 3rd, Lin SX, Larson EL. A U.S. population-based survey of Staphylococcus aureus colonization. Ann Intern Med. 2006 Mar 7;144(5):318-25. doi: 10.7326/0003-4819-144-5-200603070-00006.

    PMID: 16520472BACKGROUND

  • Wertheim HF, Melles DC, Vos MC, van Leeuwen W, van Belkum A, Verbrugh HA, Nouwen JL. The role of nasal carriage in Staphylococcus aureus infections. Lancet Infect Dis. 2005 Dec;5(12):751-62. doi: 10.1016/S1473-3099(05)70295-4.

    PMID: 16310147BACKGROUND

  • Fritz SA, Epplin EK, Garbutt J, Storch GA. Skin infection in children colonized with community-associated methicillin-resistant Staphylococcus aureus. J Infect. 2009 Dec;59(6):394-401. doi: 10.1016/j.jinf.2009.09.001. Epub 2009 Sep 9.

    PMID: 19747505BACKGROUND

MeSH Terms

Conditions

Staphylococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Laura Beane-Freeman

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2011

First Posted

June 17, 2011

Study Start

June 1, 2011

Primary Completion

March 21, 2016

Study Completion

May 21, 2020

Last Updated

May 22, 2020

Record last verified: 2020-05

Locations

US(1)