Rates of antimicrobial resistance are increasing worldwide. There is increasing evidence that physiological gut microbiota is a large reservoir of antibiotic-resistance genes. Healthy gut microbiota is known to prevent the colonization of the gastrointestinal tract by pathogens, the so-called mechanism of colonization resistance, but this protective mechanism can be altered by therapies that impair gut microbiota, including antibiotics with consequent colonization of gut pathogens, including carbapenem-resistant Enterobacterales (CRE). CRE carriers represent an epidemiological threat to other hospitalized patients and to the whole community, but are also at risk of developing clinical consequences of this colonization, including bloodstream infections from these pathogens. Neomycin has shown high efficacy in the eradication of CRE invitro. Neomycin has also been approved to treat hepatic coma by eradicating bacterial in gastrointestinal tract. Therefore, this evidence suggests that this procedure could be useful in eradicating CRE. However, current evidence is mostly limited. The aim of this study is to investigate the efficacy of Neomycin, compared with no intervention in eradicating gut colonization from CRE.
The investigators will randomize patients colonized by CRE (diagnosed by rectal swab) to Neomycin by stratified randomization according to type of CRE species (E.coli or non-E.coli). Then, patients will be followed up, rectal swabs will be repeated, and stool samples for culture and will be collected, up to 14 days after Neomycin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Neomycin (350 mg/tablet) 1.4 g three times a day (4.2 g per day) for 5 days
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Thailand
RECRUITINGNumber of patients with microbiological eradication at 2 weeks after neomycin administration
Microbiological eradication is defined as the disappearance of CRE in hospitalized patients' faces at 2 weeks after neomycin administration
Time frame: 2 weeks
Incidence of ์Neomycin toxicity (safety)
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Time frame: 2 weeks
Incidence of ์carbapenemases in isolated CRE
Number of carbapenemases in isolated CRE
Time frame: 2 weeks
Number of CRE isolates susceptible to neomycin at 2 weeks after neomycin administration
Number of CRE isolates are susceptible to neomycin at 2 weeks after neomycin administration according to the Clinical and Laboratory Standards Institute (CLSI) guideline.
Time frame: 2 weeks
Number of CRE isolates susceptible to amikacin at 2 weeks after neomycin administration
Number of CRE isolates are susceptible to amikacin after at 2 weeks after neomycin administration according to the Clinical and Laboratory Standards Institute (CLSI) guideline.
Time frame: 2 weeks
Number of CRE isolates susceptible to gentamicin at 2 weeks after neomycin administration
Number of CRE isolates are susceptible to gentamicin at 2 weeks after neomycin administration according to the Clinical and Laboratory Standards Institute (CLSI) guideline.
Time frame: 2 weeks
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