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Klebsiella pneumonia, inhabitant of the digestive tract, is a frequent nosocomial pathogen. It is currently the fourth most common cause of pneumonia and fifth most common cause of bacteremia in intensive care patients (1-3).
The aim of the present randomized controlled trial is to assess the efficacy of non-absorbable oral antibiotics in the eradication of the KPC carrier state.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: will receive PO Garamycin 80mg x 4/d | Active Comparator | will receive PO Garamycin 80mg x 4/d |
|
| Group 2 : will receive PO Colistin (Polymyxin E) 100mg x 4/d | Active Comparator |
| |
| Group 3: will receive both medications | Active Comparator |
| |
| Group 4: will not receive PO treatment | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colistin (Polymyxin E) 100mg x 4/d | Drug | Colistin (Polymyxin E) 100mg x 4/d |
|
| Measure | Description | Time Frame |
|---|---|---|
| The specific measure that will be used to determine the effect of the intervention(s): eradication rate (%). | - Is this outcome measure assessing a safety issue? Select: no | twice a week |
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Inclusion Criteria:
Inclusion Criteria
Exclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tsila Zuckerman, DR | rambam mc | Principal Investigator |
| ILANA OREN, Dr | Site Sub Investigator | Principal Investigator |
| Jacob M Rowe, Prof | Site Sub-Investigator | Principal Investigator |
| RENATO FINKELSTEIN, Prof | Site Sub-Investigator | Principal Investigator |
| Norberto Krivoy, Prof | Site Sub-Investigator | Principal Investigator |
| HANA Shprecher, Dr | Site Sub-Investigator | Principal Investigator |
| Noam Benyamini, Dr | Site Sub-Investigator | Principal Investigator |
| Salim Hadad, Dr | Site Sub-Investigator | Principal Investigator |
| Ami Neuberger, Dr | Site Sub-Investigator | Principal Investigator |
| Eyal Braun, Dr | Site Sub-Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambam Mc | Haifa | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15561858 | Result | Woodford N, Tierno PM Jr, Young K, Tysall L, Palepou MF, Ward E, Painter RE, Suber DF, Shungu D, Silver LL, Inglima K, Kornblum J, Livermore DM. Outbreak of Klebsiella pneumoniae producing a new carbapenem-hydrolyzing class A beta-lactamase, KPC-3, in a New York Medical Center. Antimicrob Agents Chemother. 2004 Dec;48(12):4793-9. doi: 10.1128/AAC.48.12.4793-4799.2004. |
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| both medications | Drug | PO Garamycin 80mg x 4/d +PO Colistin (Polymyxin E) 100mg x 4/d |
|
| will not receive PO treatment | Drug | will not receive PO treatment - will receive plecebo treatment |
|
| PO Garamycin 80mg x 4/d | Drug | PO Garamycin 80mg x 4/d |
|
| Principal Investigator |
| Ayelet Raz, Dr | Site Sub-Investigator | Principal Investigator |
| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D007710 | Klebsiella Infections |
| C536151 | Keratoconus posticus circumscriptus |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004756 | Enterobacteriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D003091 | Colistin |
| ID | Term |
|---|---|
| D011113 | Polymyxins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D055666 | Lipopeptides |
| D008055 | Lipids |
| D023181 | Antimicrobial Cationic Peptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000089882 | Antimicrobial Peptides |
| D052899 | Pore Forming Cytotoxic Proteins |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
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