Methicillin Resistant Staphylococcus AureusMRSABrazilNCT01359358
Study of Methicillin-resistant Staphylococcus Aureus (MRSA) Isolated From Infected Patients in Brazil
An observational study of Methicillin Resistant Staphylococcus Aureus, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
This project has as general objective to determine if there is any Methicillin-resistant Staphylococcus aureus (MRSA) strain disseminating in the hospital of Belo Horizonte. If this is the case, the investigators will determine if this is an international known strain by typing it by PFGE and MLST. Read more about this study
- Who is it for?
- Ages 1 month and older
- Conditions the study is for
- Methicillin Resistant Staphylococcus Aureus
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2011to not given
- 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 1 month and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: MRSA from infection or from colonization of a patient who was already infected by MRSA during the time of the study
Who may be able to join
- MRSA from infection sites
- MRSA from colonization of the patients who already was infected by MRSA during the time of the study
Who cannot join
- MRSA from colonization of a patient who has not infection caused by MRSA
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto de Física de Sao Carlos - Universidade de Sao Paulo
São Carlos, São Paulo, 13560-590
About this study
Official title: Epidemiological Study of Methicillin-resistant Staphylococcus Aureus (MRSA) Isolated From Infected Patients During a Hospital Surveillance Period
This project has as general objective to determine if there is any Methicillin-resistant Staphylococcus aureus (MRSA) strain disseminating in the hospital of Belo Horizonte. If this is the case, the investigators will determine if this is an international known strain by typing it by PFGE and MLST.
The detection of mecA gene will be performed by PCR. Their susceptibility profile to several drugs will also be accessed and it will be possible to compare the response to those drugs commonly in use to that of Daptomycin, a new drug available in Brazil.
It will be screened for reduced susceptibility to vancomycin by Macromethod Etest (MET) in order to search for VISA or hetero-VISA. Also, due to the discussions at the literature about mutations in genes that are said to be responsible for reduced susceptibility to vancomycin, the investigators will sequence these genes in all PFGE type strain of this study looking for mutations already described to compare to the screening results.
Read the detailed description
Multidrug resistant and virulent MRSA strains have been disseminating worldwide and few alternatives of treatment for diseases caused by this pathogen are available. In this study, 36 isolates from colonization or different clinical specimens from infected patients of the Hospital Rizoleta Tolentino Neves will be analyzed. These results will provide important data for doctors and nurses, such as whether there is any strain dissemination or not in the hospital what could suggest an outbreak. It will be performed molecular typing by pulsed field gel electrophoresis (PFGE) and multilocus sequence typing (MLST). The investigators will evaluate the efficiency of several antimicrobials and the frequency of h-VISA and VISA among the Brazilian MRSA. Besides, the investigators will verify the presence of mutation in genes that are involved in resistance mechanisms of VISA. According to the strains profile present in the hospital, if this is suggested that there is a dissemination of some strain, the health professionals can start a more rigid infection control measures in order to decrease the number of cases of nosocomial infection, decreasing the time of hospitalization of patients and, consequently the cost for the hospital.
- Keywords
- MRSA, MLST, PFGE, Resistance, isolated from colonization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2011 (estimated)
- Study startJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methicillin Resistant Staphylococcus AureusStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Ilana L B Camargo, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01359358
- Sponsor's protocol ID
- Novartis IFSC-USP
- Acronym
- MRSABrazil
- Status last verified
- May 2011
- First submitted
- 20 May 2011
- Last updated
- 24 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Study of Methicillin-resistant Staphylococcus Aureus (MRSA) Isolated From Infected Patients During a Hospital Surveillance Period
- ClinicalTrials.gov ID
- NCT01359358
- Acronym / sponsor ID
- MRSABrazil / Novartis IFSC-USP
- Keywords
- MRSA, MLST, PFGE, Resistance, isolated from colonization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jul 2011
- First posted
- 24 May 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.
This project has as general objective to determine if there is any Methicillin-resistant Staphylococcus aureus (MRSA) strain disseminating in the hospital of Belo Horizonte. If this is the case, the investigators will determine if this is an international known strain by typing it by PFGE and MLST.
The detection of mecA gene will be performed by PCR. Their susceptibility profile to several drugs will also be accessed and it will be possible to compare the response to those drugs commonly in use to that of Daptomycin, a new drug available in Brazil.
It will be screened for reduced susceptibility to vancomycin by Macromethod Etest (MET) in order to search for VISA or hetero-VISA. Also, due to the discussions at the literature about mutations in genes that are said to be responsible for reduced susceptibility to vancomycin, the investigators will sequence these genes in all PFGE type strain of this study looking for mutations already described to compare to the screening results.
Detailed description
Multidrug resistant and virulent MRSA strains have been disseminating worldwide and few alternatives of treatment for diseases caused by this pathogen are available. In this study, 36 isolates from colonization or different clinical specimens from infected patients of the Hospital Rizoleta Tolentino Neves will be analyzed. These results will provide important data for doctors and nurses, such as whether there is any strain dissemination or not in the hospital what could suggest an outbreak. It will be performed molecular typing by pulsed field gel electrophoresis (PFGE) and multilocus sequence typing (MLST). The investigators will evaluate the efficiency of several antimicrobials and the frequency of h-VISA and VISA among the Brazilian MRSA. Besides, the investigators will verify the presence of mutation in genes that are involved in resistance mechanisms of VISA. According to the strains profile present in the hospital, if this is suggested that there is a dissemination of some strain, the health professionals can start a more rigid infection control measures in order to decrease the number of cases of nosocomial infection, decreasing the time of hospitalization of patients and, consequently the cost for the hospital.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 month and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- MRSA from infection or from colonization of a patient who was already infected by MRSA during the time of the study
Key inclusion criteria (2 listed)
- MRSA from infection sites
- MRSA from colonization of the patients who already was infected by MRSA during the time of the study
Key exclusion criteria (1 listed)
- MRSA from colonization of a patient who has not infection caused by MRSA
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2011.
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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.
Ilana L B Camargo, PhD principal investigator
University of Sao Paulo
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 Resistant Staphylococcus Aureus, run by University of Sao Paulo at 1 site in Brazil.
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 1 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: status not confirmed, as of the sponsor's last update on 24 May 2011. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyllo Baeta MArcelo Jr, Master degree (55 31 99929631, hyllo@lustosa.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 24 May 2011.