Impact of Specific Antibiotic Therapies on the Prevalence of Human Host Resistant Bacteria (SATURN)
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|ClinicalTrials.gov Identifier: NCT01311154|
Recruitment Status : Unknown
Verified March 2011 by Tel-Aviv Sourasky Medical Center.
Recruitment status was: Recruiting
First Posted : March 9, 2011
Last Update Posted : March 9, 2011
|Condition or disease|
|Focus of Study: Carriers of Resistant Enterobacteriaceae.|
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 Type :||Observational|
|Estimated Enrollment :||400 participants|
|Official Title:||Impact of Specific Antibiotic Therapies on the Prevalence of Human Host Resistant Bacteria - WP5|
|Study Start Date :||February 2011|
|Estimated Primary Completion Date :||February 2013|
|Estimated Study Completion Date :||July 2015|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01311154
|Tel-aviv, Israel, 64239|
|Contact: Meital Kazma, Msc 03-6973625|
|Contact: Shimrit Chone, Msc 03-6973625|