Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-28 @ 6:09 PM
Study NCT ID:
NCT00753558
Status:
COMPLETED
Last Update Posted:
2010-09-21
First Post:
2008-09-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Selective Digestive Decontamination in Carriers of Carbapenem-resistant Klebsiella Pneumoniae
Sponsor:
Soroka University Medical Center
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2010-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: