Selective Digestive Decontamination in Carriers of Carbapenem-resistant Klebsiella Pneumoniae
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ClinicalTrials.gov Identifier: NCT00753558 |
Recruitment Status :
Completed
First Posted : September 16, 2008
Last Update Posted : September 21, 2010
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Condition or disease | Intervention/treatment | Phase |
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Carriage of Carbapemen-resistant Klebsialle Pneumoniae | Drug: Arm #1 :Oral solution and buccal gel of gentamicin and polymyxin E. Arm #2: Placebo. | Not Applicable |
Study Type : | Interventional (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 |
Study Start Date : | November 2008 |
Actual Primary Completion Date : | June 2010 |
Actual Study Completion Date : | July 2010 |
Arm | Intervention/treatment |
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Placebo Comparator: 2
Oral solution of 0.45% saline and oral solution of H2O & saccharine. Oral gel composed of mineral oil, gelatine powder, pectin, sodium carboxymethylcellulose, polyethylene
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Drug: Arm #1 :Oral solution and buccal gel of gentamicin and polymyxin E. Arm #2: Placebo.
Arm #1: Oral gentamicin & polymyxin E, gentamicin & polymyxin E buccal gel. Arm #2: Oral placebo solutions, placebo buccal gel. |
Active Comparator: 1
Oral solution and buccal gel of gentamicin and polymyxin E
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Drug: Arm #1 :Oral solution and buccal gel of gentamicin and polymyxin E. Arm #2: Placebo.
Arm #1: Oral gentamicin & polymyxin E, gentamicin & polymyxin E buccal gel. Arm #2: Oral placebo solutions, placebo buccal gel. |
- Eradication of CRKP carriage measured by negative rectal swabs [ Time Frame: Two days after treatment ends ]
- No new in-hospital acquisition of CRKP [ Time Frame: Six weeks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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): NCT00753558
Israel | |
Soroka University Medical Center | |
Beer Sheva, Israel, 84101 |
Other Publications:
ClinicalTrials.gov Identifier: | NCT00753558 |
Other Study ID Numbers: |
sor475808CTIL |
First Posted: | September 16, 2008 Key Record Dates |
Last Update Posted: | September 21, 2010 |
Last Verified: | September 2010 |
Pneumonia Respiratory Tract Infections Infections Lung Diseases Respiratory Tract Diseases Gentamicins Polymyxins |
Colistin Anti-Bacterial Agents Anti-Infective Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |