SDD for Eradicating CRKP Carriage
|ClinicalTrials.gov Identifier: NCT01761487|
Recruitment Status : Unknown
Verified October 2012 by Soroka University Medical Center.
Recruitment status was: Not yet recruiting
First Posted : January 4, 2013
Last Update Posted : January 4, 2013
There is an urgent need to control the current national outbreak of Carbapenem-resistent Klebsiella pneumonia (CRKP). In Israel, the death rate among CRKP carriers is 3.5 times higher than in Carbapenem-sensitive Klebsiella pneumonia carriers (44% vs. 12.5%, respectively).
In the investigators' previous study: A Randomized, Double-Blind, Placebo-Controlled Trial of Selective Digestive Decontamination (SDD) Using Oral Gentamicin and Oral Polymyxin E for Eradication of CRKP Carriage (Infect Control Hosp Epidemiol. 2012;33:14-19) the investigators have shown that the investigators' SDD regimen is effective for decolonization patients colonized with CRKP.
The investigators' assumption is that a higher dose of polymyxin E together with gentamicin (SDD drugs) for a prolonged period is needed to overcome the likelihood of a high rate of drug inactivation in the gut, thereby reaching CRKP carriage eradication.
|Condition or disease||Intervention/treatment||Phase|
|Carriers of Carbapenem-resistant Klebsiella Pneumonia||Device: Gentamicin and polymyxin E||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||SELECTIVE DIGESTIVE DECONTAMINATION USING ORAL GENTAMICIN AND ORAL POLYMYXIN E FOR ERADICATION OF CARBAPENEM-RESISTANT KLEBSIELLA PNEUMONIAE CARRIAGE IN HOSPITALIZED PATIENTS|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||February 2014|
One arm only - Gentamicin and polymyxin E
All subjects will receive:Gentamicin and polymyxin E paste applied on buccal surface four times daily + gentamicin + polymyxin E PO + Strict contact precautions
|Device: Gentamicin and polymyxin E|
- CRKP carriage at end of treatment [ Time Frame: one year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01761487
|Contact: Lisa Saidel-Odes, MDfirstname.lastname@example.org|
|Soroka University Medical Center||Not yet recruiting|
|Beer Sheva, Negev, Israel, 84101|