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

Rambam Health Care Campus200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Klebsiella Pneumoniae Carbapenemase Resistant Associated Bacteremia or Pneumonia

Interventions

Colistin (Polymyxin E) 100mg x 4/dDRUG

Colistin (Polymyxin E) 100mg x 4/d

both medicationsDRUG

PO Garamycin 80mg x 4/d +PO Colistin (Polymyxin E) 100mg x 4/d

will not receive PO treatmentDRUG

will not receive PO treatment - will receive plecebo treatment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Inclusion Criteria 1. Patient identified as a KPC carrier. 2. Patient capable to understand and sign informed consent 3. Age \> 18 4. Patient capable to receive oral medication Exclusion Criteria: * Exclusion Criteria: 1. Patient unable to sign informed consent 2. Age ≤ 18 3. Pregnant/lactating female 4. Patient not expected to survive \> 2 weeks. 5. Patient unable or not allowed to receive oral medications 6. A known allergy to study drugs.

Locations (1)

Rambam Mc

Haifa, Israel

Outcomes

Primary Outcomes

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

Time frame: twice a week

Data from ClinicalTrials.gov

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