A Phase 4 interventional study of Decolonization and Placebo (Decolonization) in Enterobacteriaceae Infections, sponsored by University Hospital, Geneva. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-08-07.
Sponsored by University Hospital, Geneva · Phase 4, Interventional, and Prevention
Multidrug-resistant Enterobacteriaceae producing extended-spectrum β-lactamases (hereafter called ESBLs) have emerged as an important cause of bloodstream infection in hospitalized patients and urinary tract infections in the community. As is the case with other multidrug-resistant organisms chronic colonization is frequent, in the case of ESBLs mostly intestinal and urinary carriage.
To the investigators knowledge no randomized, placebo-controlled clinical trial has been performed to study the efficacy of a systematic ESBL eradication strategy. Eradication of ESBL carriage would cause benefits for the individual patient - by reducing the risk of infection - and for the community - by reducing transmission. Even if eradication turns out to be impossible, transient suppression of ESBL might reduce the likelihood of transmission and thus still be beneficial from an ecologic perspective.
The purpose of the proposed study is to test the hypothesis that the administration of a 10 day course of oral antibiotics active against ESBLs can lead to decolonization of ESBL carriage in hospitalized patients.
56 studies on the registry are indexed under Enterobacteriaceae Infections; 13 are open to participants now.
This study's enrollment of 58 is below the median of 108 across 28 interventional studies indexed under Enterobacteriaceae Infections.
Browse Enterobacteriaceae Infections studies →University Hospital, Geneva is the lead sponsor of 372 studies on the registry; 68 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients can be enrolled into the study provided that all of the following criteria are met:
Exclusion Criteria:
Drug: Decolonization
Drug: Placebo (Decolonization)
Colistin sulphate (50mg 4x/d PO) + Neomycin (250mg 4x/day PO) for 10 days plus In the presence of urinary tract colonization choice of one of the following agents (according to susceptibility profile, creatinine clearance and individual contraindications) Nitrofurantoin (100mg 3x/day PO) or Norfloxacin (400mg 2x/day PO) for 5 days
Placebo
Rate of eradication of carriage with ESBL-producing Enterobacteriaceae at day 28 post-treatment
Time frame: 28 days
This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.
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Enterobacteriaceae Infections→
University Hospital, Geneva