Focus of Study: Carriers of Resistant Enterobacteriaceae.SATURNNCT01311154
Impact of Specific Antibiotic Therapies on the Prevalence of Human Host Resistant Bacteria
An observational study of Focus of Study: Carriers of Resistant Enterobacteriaceae., run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
The proposed study is distinctive in studying known carriers of resistant Enterobacteriaceae. It examines both phenotypic and genotypic expansion in the AMR bacterial population as a function of antibiotic treatment, and examines the effect of antibiotics on the dissemination of resistance genes from species to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Focus of Study: Carriers of Resistant Enterobacteriaceae.
- How many people
- 400 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2011to Jul 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: known carriers of resistant Enterobacteriaceae
Who may be able to join
- known carriers of resistant Enterobacteriaceae
Who cannot join
- no exclusion criteria
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Tasmc
Tel Aviv, 64239
Meital Kazma, Msc, 03-6973625
Shimrit Chone, Msc, 03-6973625
About this study
Official title: Impact of Specific Antibiotic Therapies on the Prevalence of Human Host Resistant Bacteria - WP5
The proposed study is distinctive in studying known carriers of resistant Enterobacteriaceae. It examines both phenotypic and genotypic expansion in the AMR bacterial population as a function of antibiotic treatment, and examines the effect of antibiotics on the dissemination of resistance genes from species to species. It will examine CRE, important emerging pathogens, which are a significant threat to public health, but yet not well studied. The proposed study will use an interdisciplinary approach, combining PK/PD, phenotypic, and genetic data to understand the effect of antibiotics on the likelihood of spread of AMR. Most previous studies have focused on the effect of antibiotic agents on clinical detection, infection or acquisition of AMR among non-carriers67,68. Other studies have looked at the effects on colonisation-resistance mostly among healthy volunteers69. Very few studies have examined the effects of various antibiotic agents on carriers of ARB and those focused primarily on vancomycin resistant enterococci (VRE)70. No similar studies have been conducted with regard to ESBL or to CRE. Correlation with clinical factors and environmental contamination has not been determined in previously published studies. The proposed study also extends the analysis to the effect of antibiotic treatment on dissemination of resistance genes which may be of great importance as these events may lead to emergence of new AMR strains and species. The proposed study not only examines the effects of various antibiotic agents and classes, but also the effects of duration of treatment and PK/PD indices on amplification of ARB. The study will also examine the effect of antibiotics on the epidemicity and fitness of colonising strains
Read the detailed description
We will conduct an observational longitudinal prospective study in 3 hospitals in units with high prevalence of resistant organisms. Consenting patients will be screened for carriage of AMR organisms at admission, and those found to be carriers of the target ARB will be included in the longitudinal study. To improve the yield of screening we may use risk stratification based on risk factors identified at each center. Patients included in the longitudinal study will be asked to provide serial stool samples every 2-3 days during hospitalisation (rectal swab will be allowed as replacement for stool specimen, after developing appropriate methodology to correlate between stool samples and rectal swabs).
These samples will be analysed using quantitative cultures for the number of resistant organisms, and samples will be subject to quantitative real time PCR to quantify resistant genes (CTX-M, TEM, SHV, KPC, VIM as required). In parallel, environmental contamination will be examined and quantified using similar methods. Data will be collected daily regarding antibiotic treatment, other medications, clinical parameters, bowel movements and presence of diarrhoea, and various PK/PD indices. The target antibiotic for this study include commonly use agents in the hospital setting including quinolones, cephalosporins, piperacillin/tazobactam, ertapenem, imipenem, doripenem, metronidazole, clindamycin and aminoglycosides. The duration, the sequential order of treatment and PK/PD indices will be examined. The effects of surgical antibiotic prophylaxis will be examined as an important end point. The effects of the target antibiotic agents/classes on selection, enrichment, and spread of the target AMR organisms. Analyses will be conducted to compare: 1. the effects of various antibiotics 2. the effect of duration of therapy 3. the durability of the effect (posttreatment). 4. The effects of PK/PD indices.
Secondary analysis will examine the risk of developing infections as function of various factors including time and load of carriage of resistant organisms and of exposure to antibiotics will be performed. Correlation with clinical isolates will be performed including typing, gene and plasmid analyses to determine correlation between colonising and infecting strains. Experiment simulating patient contact will be conducted to examine contamination of hands, gloves and gowns after contact in order to correlate between environmental contamination and contamination of healthcare workers. Additional work will be conducted on profiling bacterial communities by DNA fingerprinting techniques using length hetrogeneity (LH-PCR) and automated ribososmal internal spacer analysis (ARISA) on a sample of the patients studied.
- Keywords
- carriers, resistant Enterobacteriaceae, AMR, antibiotic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2011 (estimated)
- Study startFeb 2011
- Primary completionFeb 2013 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focus of Study: Carriers of Resistant Enterobacteriaceae.Studies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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
- Cohort
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Collaborators
- European Union
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01311154
- Sponsor's protocol ID
- TASMC-0425-10-TLV
- Acronym
- SATURN
- Status last verified
- Mar 2011
- First submitted
- 7 Mar 2011
- Last updated
- 9 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Specific Antibiotic Therapies on the Prevalence of Human Host Resistant Bacteria - WP5
- ClinicalTrials.gov ID
- NCT01311154
- Acronym / sponsor ID
- SATURN / TASMC-0425-10-TLV
- Keywords
- carriers, resistant Enterobacteriaceae, AMR, antibiotic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Collaborators
- European Union
- Study start
- Feb 2011
- Primary completion
- Feb 2013 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 9 Mar 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.
The proposed study is distinctive in studying known carriers of resistant Enterobacteriaceae. It examines both phenotypic and genotypic expansion in the AMR bacterial population as a function of antibiotic treatment, and examines the effect of antibiotics on the dissemination of resistance genes from species to species. It will examine CRE, important emerging pathogens, which are a significant threat to public health, but yet not well studied. The proposed study will use an interdisciplinary approach, combining PK/PD, phenotypic, and genetic data to understand the effect of antibiotics on the likelihood of spread of AMR. Most previous studies have focused on the effect of antibiotic agents on clinical detection, infection or acquisition of AMR among non-carriers67,68. Other studies have looked at the effects on colonisation-resistance mostly among healthy volunteers69. Very few studies have examined the effects of various antibiotic agents on carriers of ARB and those focused primarily on vancomycin resistant enterococci (VRE)70. No similar studies have been conducted with regard to ESBL or to CRE. Correlation with clinical factors and environmental contamination has not been determined in previously published studies. The proposed study also extends the analysis to the effect of antibiotic treatment on dissemination of resistance genes which may be of great importance as these events may lead to emergence of new AMR strains and species. The proposed study not only examines the effects of various antibiotic agents and classes, but also the effects of duration of treatment and PK/PD indices on amplification of ARB. The study will also examine the effect of antibiotics on the epidemicity and fitness of colonising strains
Detailed description
We will conduct an observational longitudinal prospective study in 3 hospitals in units with high prevalence of resistant organisms. Consenting patients will be screened for carriage of AMR organisms at admission, and those found to be carriers of the target ARB will be included in the longitudinal study. To improve the yield of screening we may use risk stratification based on risk factors identified at each center. Patients included in the longitudinal study will be asked to provide serial stool samples every 2-3 days during hospitalisation (rectal swab will be allowed as replacement for stool specimen, after developing appropriate methodology to correlate between stool samples and rectal swabs).
These samples will be analysed using quantitative cultures for the number of resistant organisms, and samples will be subject to quantitative real time PCR to quantify resistant genes (CTX-M, TEM, SHV, KPC, VIM as required). In parallel, environmental contamination will be examined and quantified using similar methods. Data will be collected daily regarding antibiotic treatment, other medications, clinical parameters, bowel movements and presence of diarrhoea, and various PK/PD indices. The target antibiotic for this study include commonly use agents in the hospital setting including quinolones, cephalosporins, piperacillin/tazobactam, ertapenem, imipenem, doripenem, metronidazole, clindamycin and aminoglycosides. The duration, the sequential order of treatment and PK/PD indices will be examined. The effects of surgical antibiotic prophylaxis will be examined as an important end point. The effects of the target antibiotic agents/classes on selection, enrichment, and spread of the target AMR organisms. Analyses will be conducted to compare: 1. the effects of various antibiotics 2. the effect of duration of therapy 3. the durability of the effect (posttreatment). 4. The effects of PK/PD indices.
Secondary analysis will examine the risk of developing infections as function of various factors including time and load of carriage of resistant organisms and of exposure to antibiotics will be performed. Correlation with clinical isolates will be performed including typing, gene and plasmid analyses to determine correlation between colonising and infecting strains. Experiment simulating patient contact will be conducted to examine contamination of hands, gloves and gowns after contact in order to correlate between environmental contamination and contamination of healthcare workers. Additional work will be conducted on profiling bacterial communities by DNA fingerprinting techniques using length hetrogeneity (LH-PCR) and automated ribososmal internal spacer analysis (ARISA) on a sample of the patients studied.
Study design
- Observational model
- Cohort
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- known carriers of resistant Enterobacteriaceae
Key inclusion criteria (1 listed)
- known carriers of resistant Enterobacteriaceae
Key exclusion criteria (1 listed)
- no exclusion criteria
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 9 Mar 2011.
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.
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 Focus of Study: Carriers of Resistant Enterobacteriaceae., run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 1 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 9 Mar 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 Israel. 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?
Each site lists its own contact: choose the nearest one under Trial locations. 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 9 Mar 2011.