Methicillin ResistanceNCT00254527
Colonization, Infection, and Molecular Typing of Methicillin-Resistant Staphylococcus Aureus (MRSA) in Children.
An observational study of Methicillin Resistance and Staphylococcus Aureus, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial summary
The intent of this study is to: 1. Define the prevalence of MRSA carriage in the pediatric population in Kansas City. 2. Systematically define patient risk factors for MRSA carriage and infection. 3. Read more about this study
- Who is it for?
- Ages 3 months to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Methicillin Resistance, Staphylococcus Aureus
- How many people
- 477 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Apr 2007
- 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 3 months to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Colonization:
- Children ages 3 months to 12 years
- Invasive:
- Invasive MRSA infection
Who cannot join
- Colonization:
- -None
- Invasive:
- -Those without invasive MRSA infection
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108
About this study
The intent of this study is to:
- Define the prevalence of MRSA carriage in the pediatric population in Kansas City.
- Systematically define patient risk factors for MRSA carriage and infection.
- Characterize the unique genetic characteristics of MRSA strains, both community acquired (CA) and healthcare associated (HCA) that are present in the different pediatric populations.
Read the detailed description
Staphylococcus aureus (SA) are responsible for both localized and invasive infections including carbuncles, cellulitis, lymph node abscess, and wound infections among others. SA is a ubiquitous environmental organism that colonizes 30-50% adults and more than 50% of children with underlying skin disorders. Hematogenous seeding can result in fulminant infection, and sites as diverse as bone, joint, lung, muscle, pericardium, endocardium, and other vascular structures can be involved. Factors which are known to increase the risk for colonization include the presence of underlying skin disorders and history of frequent needle use which occur in the setting of diabetes, or hemodialysis. Health care workers have traditionally been noted to have higher carriage rates.
MRSA strains emerged in the last two decades in the US and similarities to the evolution of penicillin resistant S. aureus were noted with colonization and infection in the hospital based setting noted first. Again, risk factors for MRSA colonization or infection in the hospital were noted to include prior antibiotic exposure, admission to an intensive care unit, surgery, and exposure to an MRSA-colonized patient. Emergence of CA-MRSA strains has been noted in the last decade having resistance to methicillin and erythromycin but susceptibility to clindamycin. These strains have challenged the practitioner's approach to the treatment of common skin and soft tissue infections as well as the management of invasive disease. The importance of such strains was underscored by the 1999 report detailing the deaths of 4 US children with invasive MRSA infection, none of whom had identifiable MRSA risk factors. Pulsed field typing of the isolates confirmed that these community strains were distinct from nosocomial strains isolated from patients in local hospitals.
This study seeks to more clearly define the prevalence of MRSA carriage; better identify risk factors through personal interview; and further identify resistance patterns and molecular strains. This data will guide physicians at Children's Mercy and in the community at large in choosing the best treatment option for children with MRSA infections.
The absence of traditional risk factors for MRSA infection has been noted in children with CA infections. Many studies that describe risk factors in MRSA patients do so by retrospective review of the medical record. Misclassification of patients may occur as physicians do not routinely document the presence or absence of such risk factors, particularly among household contacts.
This study will look at nasal colonization for 500 children in the Kansas City area to determine prevalence of MRSA colonization. During the study period, all invasive MRSA isolates will also be collected. Pulsed field typing will be done to determine whether the strains are community or healthcare associated and both groups will be compared.
- Conditions
- Methicillin Resistance, Staphylococcus Aureus
- Keywords
- Methicillin Resistant Staphylococcus aureus, Children, Colonization, Risk Factor
- Medical subject headings
- Staphylococcal Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2005 (estimated)
- Study startJan 2005
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Methicillin ResistanceStudies of the same condition, open and under way.
- 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
- Time perspective
- Other
- Enrolment
- 477 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Investigators
- Emily A Thorell, MD, Principal investigator, Children's Mercy Hospital Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00254527
- Sponsor's protocol ID
- IRB# 04 11-135E
- Status last verified
- Nov 2005
- First submitted
- 14 Nov 2005
- Last updated
- 2 May 2007
- Results posted
- No
Publications
Wadlvogel FA. Staphylococcus aureus. In: Mandell GL, Bennett JE, Dolin R, editors. Principles and Practice of Infectious Diseases. 5th ed. Philadelphia: Churchill Livingstone, 2000. p.2072-3
Kirby WM. EXTRACTION OF A HIGHLY POTENT PENICILLIN INACTIVATOR FROM PENICILLIN RESISTANT STAPHYLOCOCCI. Science. 1944 Jun 2;99(2579):452-3. doi: 10.1126/science.99.2579.452.
PubMed 17798398ROZWADOWSKA-DOWZENKO M, LAMERS H. [Infection by penicillin resistant staphylococci]. Pol Tyg Lek (Wars). 1951 May 7;6(18-19):613-7. No abstract available. Undetermined Language.
PubMed 14875525Ross S, Rodriguez W, Controni G, Khan W. Staphylococcal susceptibility to penicillin G. The changing pattern among community strains. JAMA. 1974 Aug 19;229(8):1075-7. No abstract available.
PubMed 4276728Gross-Schulman S, Dassey D, Mascola L, Anaya C. Community-acquired methicillin-resistant Staphylococcus aureus. JAMA. 1998 Aug 5;280(5):421-2. No abstract available.
PubMed 9701074L'Heriteau F, Lucet JC, Scanvic A, Bouvet E. Community-acquired methicillin-resistant Staphylococcus aureus and familial transmission. JAMA. 1999 Sep 15;282(11):1038-9. doi: 10.1001/jama.282.11.1038. No abstract available.
PubMed 10493201Centers for Disease Control and Prevention (CDC). Four pediatric deaths from community-acquired methicillin-resistant Staphylococcus aureus - Minnesota and North Dakota, 1997-1999. MMWR Morb Mortal Wkly Rep. 1999 Aug 20;48(32):707-10.
PubMed 21033181Bartlett PC, Martin RJ, Cahill BR. Furunculosis in a high school football team. Am J Sports Med. 1982 Nov-Dec;10(6):371-4. doi: 10.1177/036354658201000611.
PubMed 7180958Lindenmayer JM, Schoenfeld S, O'Grady R, Carney JK. Methicillin-resistant Staphylococcus aureus in a high school wrestling team and the surrounding community. Arch Intern Med. 1998 Apr 27;158(8):895-9. doi: 10.1001/archinte.158.8.895.
PubMed 9570176Thorell E, Jackson MA, Bratcher D, Swanson DS, Selvarangan R. Antimicrobial Resistance of Staphylococcus aureus from Kansas City Children: What is the Appropriate Current Therapy for Pediatric Staphylococcal Infections? 42nd Annual Meeting of Infectious Diseases Society of America, Boston, Sept 30- Oct 3, 2004
Chambers HF. The changing epidemiology of Staphylococcus aureus? Emerg Infect Dis. 2001 Mar-Apr;7(2):178-82. doi: 10.3201/eid0702.010204.
PubMed 11294701Hussain FM, Boyle-Vavra S, Daum RS. Community-acquired methicillin-resistant Staphylococcus aureus colonization in healthy children attending an outpatient pediatric clinic. Pediatr Infect Dis J. 2001 Aug;20(8):763-7. doi: 10.1097/00006454-200108000-00009.
PubMed 11734738McDougal LK, Steward CD, Killgore GE, Chaitram JM, McAllister SK, Tenover FC. Pulsed-field gel electrophoresis typing of oxacillin-resistant Staphylococcus aureus isolates from the United States: establishing a national database. J Clin Microbiol. 2003 Nov;41(11):5113-20. doi: 10.1128/JCM.41.11.5113-5120.2003.
PubMed 14605147
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colonization, Infection, and Molecular Typing of Methicillin-Resistant Staphylococcus Aureus (MRSA) in Children.
- ClinicalTrials.gov ID
- NCT00254527
- Acronym / sponsor ID
- IRB# 04 11-135E
- Conditions
- Methicillin Resistance, Staphylococcus Aureus
- Keywords
- Methicillin Resistant Staphylococcus aureus, Children, Colonization, Risk Factor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 477 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Study start
- Jan 2005
- Study completion
- Apr 2007 (actual)
- First posted
- 16 Nov 2005 (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.
The intent of this study is to:
- Define the prevalence of MRSA carriage in the pediatric population in Kansas City.
- Systematically define patient risk factors for MRSA carriage and infection.
- Characterize the unique genetic characteristics of MRSA strains, both community acquired (CA) and healthcare associated (HCA) that are present in the different pediatric populations.
Detailed description
Staphylococcus aureus (SA) are responsible for both localized and invasive infections including carbuncles, cellulitis, lymph node abscess, and wound infections among others. SA is a ubiquitous environmental organism that colonizes 30-50% adults and more than 50% of children with underlying skin disorders. Hematogenous seeding can result in fulminant infection, and sites as diverse as bone, joint, lung, muscle, pericardium, endocardium, and other vascular structures can be involved. Factors which are known to increase the risk for colonization include the presence of underlying skin disorders and history of frequent needle use which occur in the setting of diabetes, or hemodialysis. Health care workers have traditionally been noted to have higher carriage rates.
MRSA strains emerged in the last two decades in the US and similarities to the evolution of penicillin resistant S. aureus were noted with colonization and infection in the hospital based setting noted first. Again, risk factors for MRSA colonization or infection in the hospital were noted to include prior antibiotic exposure, admission to an intensive care unit, surgery, and exposure to an MRSA-colonized patient. Emergence of CA-MRSA strains has been noted in the last decade having resistance to methicillin and erythromycin but susceptibility to clindamycin. These strains have challenged the practitioner's approach to the treatment of common skin and soft tissue infections as well as the management of invasive disease. The importance of such strains was underscored by the 1999 report detailing the deaths of 4 US children with invasive MRSA infection, none of whom had identifiable MRSA risk factors. Pulsed field typing of the isolates confirmed that these community strains were distinct from nosocomial strains isolated from patients in local hospitals.
This study seeks to more clearly define the prevalence of MRSA carriage; better identify risk factors through personal interview; and further identify resistance patterns and molecular strains. This data will guide physicians at Children's Mercy and in the community at large in choosing the best treatment option for children with MRSA infections.
The absence of traditional risk factors for MRSA infection has been noted in children with CA infections. Many studies that describe risk factors in MRSA patients do so by retrospective review of the medical record. Misclassification of patients may occur as physicians do not routinely document the presence or absence of such risk factors, particularly among household contacts.
This study will look at nasal colonization for 500 children in the Kansas City area to determine prevalence of MRSA colonization. During the study period, all invasive MRSA isolates will also be collected. Pulsed field typing will be done to determine whether the strains are community or healthcare associated and both groups will be compared.
Study design
- Time perspective
- Other
Who may qualify
- Ages
- 3 months to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children ages 3 months to 12 years
- Invasive MRSA infection
Key exclusion criteria (4 listed)
- -None
- -Those without invasive MRSA infection
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
Not reported in the source record.
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 2 May 2007.
- BackgroundWadlvogel FA. Staphylococcus aureus. In: Mandell GL, Bennett JE, Dolin R, editors. Principles and Practice of Infectious Diseases. 5th ed. Philadelphia: Churchill Livingstone, 2000. p.2072-3
- Background: PubMed 17798398Kirby WM. EXTRACTION OF A HIGHLY POTENT PENICILLIN INACTIVATOR FROM PENICILLIN RESISTANT STAPHYLOCOCCI. Science. 1944 Jun 2;99(2579):452-3. doi: 10.1126/science.99.2579.452.
- Background: PubMed 14875525ROZWADOWSKA-DOWZENKO M, LAMERS H. [Infection by penicillin resistant staphylococci]. Pol Tyg Lek (Wars). 1951 May 7;6(18-19):613-7. No abstract available. Undetermined Language.
- Background: PubMed 4276728Ross S, Rodriguez W, Controni G, Khan W. Staphylococcal susceptibility to penicillin G. The changing pattern among community strains. JAMA. 1974 Aug 19;229(8):1075-7. No abstract available.
- Background: PubMed 9701074Gross-Schulman S, Dassey D, Mascola L, Anaya C. Community-acquired methicillin-resistant Staphylococcus aureus. JAMA. 1998 Aug 5;280(5):421-2. No abstract available.
- Background: PubMed 10493201L'Heriteau F, Lucet JC, Scanvic A, Bouvet E. Community-acquired methicillin-resistant Staphylococcus aureus and familial transmission. JAMA. 1999 Sep 15;282(11):1038-9. doi: 10.1001/jama.282.11.1038. No abstract available.
- Background: PubMed 21033181Centers for Disease Control and Prevention (CDC). Four pediatric deaths from community-acquired methicillin-resistant Staphylococcus aureus - Minnesota and North Dakota, 1997-1999. MMWR Morb Mortal Wkly Rep. 1999 Aug 20;48(32):707-10.
- Background: PubMed 7180958Bartlett PC, Martin RJ, Cahill BR. Furunculosis in a high school football team. Am J Sports Med. 1982 Nov-Dec;10(6):371-4. doi: 10.1177/036354658201000611.
- Background: PubMed 9570176Lindenmayer JM, Schoenfeld S, O'Grady R, Carney JK. Methicillin-resistant Staphylococcus aureus in a high school wrestling team and the surrounding community. Arch Intern Med. 1998 Apr 27;158(8):895-9. doi: 10.1001/archinte.158.8.895.
- BackgroundThorell E, Jackson MA, Bratcher D, Swanson DS, Selvarangan R. Antimicrobial Resistance of Staphylococcus aureus from Kansas City Children: What is the Appropriate Current Therapy for Pediatric Staphylococcal Infections? 42nd Annual Meeting of Infectious Diseases Society of America, Boston, Sept 30- Oct 3, 2004
- Background: PubMed 11294701Chambers HF. The changing epidemiology of Staphylococcus aureus? Emerg Infect Dis. 2001 Mar-Apr;7(2):178-82. doi: 10.3201/eid0702.010204.
- Background: PubMed 11734738Hussain FM, Boyle-Vavra S, Daum RS. Community-acquired methicillin-resistant Staphylococcus aureus colonization in healthy children attending an outpatient pediatric clinic. Pediatr Infect Dis J. 2001 Aug;20(8):763-7. doi: 10.1097/00006454-200108000-00009.
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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.
Emily A Thorell, MD principal investigator
Children's Mercy Hospital Kansas City
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 Methicillin Resistance and Staphylococcus Aureus, run by Children's Mercy Hospital Kansas City 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 4 inclusion and 4 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 2 May 2007. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00254527, which also lists 13 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 2 May 2007.