Carriage of Carbapemen-resistant Klebsialle Pneumoniae Clinical Trial
Official title:
A Randomized,Double-Blind,Placebo-Controled Trial of Selective Digestive Decontamination Using Oral Gentamicin and Oral Polymyxin E for Eradication of Carbapenem-Resistant Klebsiella Pneumoniae Carriage
There is an urgent need to control our current national outbreak of carbapenem-resistant Klebsiella pneumoniae (CRKP). The purpose of this study is to eradicate CRKP gastrointestinal carriage using selective digestive decontamination (SDD); with buccal and oral gentamicin and polymyxin E administration. This will reduce infections and hopefully mortality caused by CRKP.
| Status | Completed |
| Enrollment | 0 |
| Est. completion date | July 2010 |
| Est. primary completion date | June 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Hospitalized men and women with a positive rectal swab for CRKP - Age 18 years or older Exclusion Criteria: - Age less than 18 years - Pregnant women, lactating women - A known allergy to the study drugs |
N/A
| Country | Name | City | State |
|---|---|---|---|
| Israel | Soroka University Medical Center | Beer Sheva |
| Lead Sponsor | Collaborator |
|---|---|
| Soroka University Medical Center |
Israel,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Eradication of CRKP carriage measured by negative rectal swabs | Two days after treatment ends | No | |
| Secondary | No new in-hospital acquisition of CRKP | Six weeks | No |