SDD for Eradicating CRKP Carriage
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|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 ]
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): NCT01761487
|Contact: Lisa Saidel-Odes, MDfirstname.lastname@example.org|
|Soroka University Medical Center||Not yet recruiting|
|Beer Sheva, Negev, Israel, 84101|