Staphylococcus Aureus InfectionNCT01375621
Livestock Contact and MRSA in Rural Areas
An observational study of Staphylococcus Aureus Infection, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 100 years
- Conditions the study is for
- Staphylococcus Aureus Infection
- How many people
- 1,342 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2011to 21 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Individuals enrolled in the Agricultural Health Study, including those who raise swine; and a matched population-based group with no livestock exposure.
Who may be able to join
- Cohort A: Participant or child of participant in the Agricultural Health Study
- Cohort B: Resident of Iowa
Who cannot join
- Cohort A: Age <8 months
- Cohort B: Age <8 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the detailed description
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:
- 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.
- 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.
- Conditions
- Staphylococcus Aureus Infection
- Keywords
- Farming, Antibiotic Resistant, Bacteria
- Medical subject headings
- Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| AHS cohort | population of S. aureus asymptomatic rural Iowans | |
| Non-AHS group | symptomatic S. aureus infections in rural Iowans. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2011 (estimated)
- Study start1 Jun 2011
- Primary completion21 Mar 2016
- Study completion21 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Staphylococcus Aureus InfectionStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,342 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Laura Beane-Freeman, Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01375621
- Sponsor's protocol ID
- 999911169
- Other IDs
- 11-C-N169
- Status last verified
- May 2020
- First submitted
- 16 Jun 2011
- Last updated
- 22 May 2020
- Results posted
- No
Publications
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.
PubMed 16520472Wertheim 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.
PubMed 16310147Fritz 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.
PubMed 19747505
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Rural MRSA : Is Livestock Contact a Risk Factor?
- ClinicalTrials.gov ID
- NCT01375621
- Acronym / sponsor ID
- 999911169
- Conditions
- Staphylococcus Aureus Infection
- Keywords
- Farming, Antibiotic Resistant, Bacteria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,342 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 1 Jun 2011 (actual)
- Primary completion
- 21 Mar 2016 (actual)
- Study completion
- 21 May 2020 (actual)
- First posted
- 17 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- 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.
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AHS cohort | – | –population of S. aureus asymptomatic rural Iowans |
| Non-AHS group | – | –symptomatic S. aureus infections in rural Iowans. |
Who may qualify
- Ages
- 6 months to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals enrolled in the Agricultural Health Study, including those who raise swine; and a matched population-based group with no livestock exposure.
Key inclusion criteria (2 listed)
- Cohort A: Participant or child of participant in the Agricultural Health Study
- Cohort B: Resident of Iowa
Key exclusion criteria (2 listed)
- Cohort A: Age <8 months
- Cohort B: Age <8 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Epidemiology of MRSA in AHS cohort
Time frame: ongoing
Establish the prevalence, molecular subtypes, and antibiotic resistance profiles of S. aureus in populations of rural Iowans, and determine risk factors for colonization.
Epidemiology of MRSA in matched, population-based non-AHS group
Time frame: ongoing
Determine the incidence and molecular epidemiology of symptomatic S. aureus infections in rural Iowans.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2020.
- Background: PubMed 16520472Graham 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.
- Background: PubMed 16310147Wertheim 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.
- Background: PubMed 19747505Fritz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Beane-Freeman principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Staphylococcus Aureus Infection, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epidemiology of MRSA in AHS cohort (time frame: ongoing). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01375621, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2020.