A Study Evaluating the Role of Oral Antibiotics in an Aim to Eradicate Carrier State of Carbapenem- Resistant Klebsiella Pneumonia (KPC).

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Open Label Study Evaluating the Role of Oral Antibiotics in an Aim to Eradicate Carrier State of Carbapenem- Resistant Klebsiella Pneumonia (KPC).

Conditions
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Klebsiella Pneumoniae Carbapenemase Resistant Associated Bacteremia or Pneumonia

Intervention / Treatment
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* Drug: Colistin (Polymyxin E) 100mg x 4/d
* Drug: both medications
* Drug: will not receive PO treatment
* Drug: PO Garamycin 80mg x 4/d


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion Criteria Patient identified as a KPC carrier. Patient capable to understand and sign informed consent Age > 18 Patient capable to receive oral medication Exclusion Criteria: Exclusion Criteria: Patient unable to sign informed consent Age ≤ 18 Pregnant/lactating female Patient not expected to survive > 2 weeks. Patient unable or not allowed to receive oral medications A known allergy to study drugs.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1: will receive PO Garamycin 80mg x 4/d<br>will receive PO Garamycin 80mg x 4/d | Drug: PO Garamycin 80mg x 4/d<br>* PO Garamycin 80mg x 4/d<br>|
| Active Comparator: Group 2 : will receive PO Colistin (Polymyxin E) 100mg x 4/d<br> | Drug: Colistin (Polymyxin E) 100mg x 4/d<br>* Colistin (Polymyxin E) 100mg x 4/d<br>|
| Active Comparator: Group 3: will receive both medications<br> | Drug: both medications<br>* PO Garamycin 80mg x 4/d +PO Colistin (Polymyxin E) 100mg x 4/d<br>|
| Placebo Comparator: Group 4: will not receive PO treatment<br> | Drug: will not receive PO treatment<br>* will not receive PO treatment - will receive plecebo treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Klebsiella , pneumonia, carbapenem-hydrolyzing lactamase, carbapenem-resistant Klebsiella (KPC), eradication,